title: Constitution d'Une Cohorte Nationale rétrospective de Survivants d'un Cancer Solide de l'Enfant diagnostiqué Avant 2000

acronym: FCCSS

summary:
The FCCSS is a multicentric national large-scale collaborative population-based study of children treated for a solid tumor before 2000 in France and before the age of 19 years.

The study is concerned by improving knowledge about the long-term effects caused by cancer and its treatments including adverse health and social outcomes.

The main reason of the FCCSS is to estimate the risk of adverse health and social outcomes that may occur after a cancer treatment and to prevent them by providing adapted follow-up care.

The cohort will be followed for up to 20 years from 2011.

ReferenceCitation: Pein F, Iserin L, de Vathaire F, Lemerle J. [Cardiac toxicity of cancer treatment regimes in children and adolescents: physiopathology, clinical data and the paediatric oncologist's point of view]. Bull Cancer. 2004 Nov;91 Suppl 3:185-91. Review. French.

ReferenceCitation: Haddy N, El-Fayech C, Guibout C, Adjadj E, Thomas-Teinturier C, Oberlin O, Veres C, Pacquement H, Jackson A, Munzer M, N'Guyen TD, Bondiau PY, Berchery D, Laprie A, Bridier A, Lefkopoulos D, Schlumberger M, Rubino C, Diallo I, de Vathaire F. Thyroid adenomas after solid cancer in childhood. Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):e209-15. doi: 10.1016/j.ijrobp.2012.03.044. Epub 2012 Jun 5.

family: Haddy

full_name: Nadia Haddy

given: Nadia

family: El-Fayech

full_name: Chiraz El-Fayech

given: Chiraz

family: Guibout

full_name: Catherine Guibout

family: Adjadj

full_name: Elisabeth Adjadj

given: Elisabeth

family: Thomas-Teinturier

full_name: Cécile Thomas-Teinturier

given: Cécile

family: Oberlin

full_name: Odile Oberlin

given: Odile

family: Veres

full_name: Cristina Veres

given: Cristina

family: Pacquement

full_name: Hélène Pacquement

given: Hélène

family: Jackson

full_name: Angela Jackson

given: Angela

family: Munzer

full_name: Martine Munzer

given: Martine

family: N'Guyen

full_name: Tan Dat N'Guyen

given: Tan Dat

family: Bondiau

full_name: Pierre-Yves Bondiau

given: Pierre-Yves

family: Berchery

full_name: Delphine Berchery

given: Delphine

family: Laprie

full_name: Anne Laprie

given: Anne

family: Bridier

full_name: André Bridier

given: André

family: Lefkopoulos

full_name: Dimitri Lefkopoulos

given: Dimitri

family: Schlumberger

full_name: Martin Schlumberger

given: Martin

family: Rubino

full_name: Carole Rubino

given: Carole

family: Diallo

full_name: Ibrahima Diallo

given: Ibrahima

family: de Vathaire

full_name: Florent de Vathaire

given: Florent

journal_name: International Journal of Radiation Oncology*Biology*Physics

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Thyroid Adenomas After Solid Cancer in Childhood

ReferenceCitation: Tukenova M, Diallo I, Anderson H, Hawkins M, Garwicz S, Sankila R, El Fayech C, Winter D, Rubino C, Adjadj E, Haddy N, Oberlin O, Moller T, Langmark F, Tryggvadottir L, Pacquement H, Svahn-Tapper G, de Vathaire F. Second malignant neoplasms in digestive organs after childhood cancer: a cohort-nested case-control study. Int J Radiat Oncol Biol Phys. 2012 Mar 1;82(3):e383-90. doi: 10.1016/j.ijrobp.2011.05.069.

family: Tukenova

full_name: Markhaba Tukenova

given: Markhaba

repository_institution: Lund University - Lund University Publications

title: Second Malignant Neoplasms in Digestive Organs After Childhood Cancer: A Cohort-Nested Case-Control Study

ReferenceCitation: Haddy N, Mousannif A, Tukenova M, Guibout C, Grill J, Dhermain F, Pacquement H, Oberlin O, El-Fayech C, Rubino C, Thomas-Teinturier C, Le-Deley MC, Hawkins M, Winter D, Chavaudra J, Diallo I, de Vathaire F. Relationship between the brain radiation dose for the treatment of childhood cancer and the risk of long-term cerebrovascular mortality. Brain. 2011 May;134(Pt 5):1362-72. doi: 10.1093/brain/awr071.

ReferenceCitation: Dufour C, Oberlin O, De Vathaire F. [Offspring of childhood cancer survivors]. Arch Pediatr. 2010 Jun;17(6):926-7. doi: 10.1016/S0929-693X(10)70182-2. Review. French.

title: Descendance des patients guéris d’un cancer

ReferenceCitation: Tukenova M, Guibout C, Hawkins M, Quiniou E, Mousannif A, Pacquement H, Winter D, Bridier A, Lefkopoulos D, Oberlin O, Diallo I, de Vathaire F. Radiation therapy and late mortality from second sarcoma, carcinoma, and hematological malignancies after a solid cancer in childhood. Int J Radiat Oncol Biol Phys. 2011 Jun 1;80(2):339-46. doi: 10.1016/j.ijrobp.2010.02.004. Epub 2010 Jun 18.

title: Radiation Therapy and Late Mortality From Second Sarcoma, Carcinoma, and Hematological Malignancies After a Solid Cancer in Childhood

ReferenceCitation: Tukenova M, Diallo I, Hawkins M, Guibout C, Quiniou E, Pacquement H, Dhermain F, Shamsaldin A, Oberlin O, de Vathaire F. Long-term mortality from second malignant neoplasms in 5-year survivors of solid childhood tumors: temporal pattern of risk according to type of treatment. Cancer Epidemiol Biomarkers Prev. 2010 Mar;19(3):707-15. doi: 10.1158/1055-9965.EPI-09-1156. Epub 2010 Mar 3.

journal_name: Cancer Epidemiology Biomarkers & Prevention

publisher: American Association for Cancer Research (AACR)

publisher_dissemination: American Association for Cancer Research

publisher_group: American Association for Cancer Research

publisher_normalized: American Association for Cancer Research

title: Long-term Mortality from Second Malignant Neoplasms in 5-Year Survivors of Solid Childhood Tumors: Temporal Pattern of Risk according to Type of Treatment

ReferenceCitation: Tukenova M, Guibout C, Oberlin O, Doyon F, Mousannif A, Haddy N, Guérin S, Pacquement H, Aouba A, Hawkins M, Winter D, Bourhis J, Lefkopoulos D, Diallo I, de Vathaire F. Role of cancer treatment in long-term overall and cardiovascular mortality after childhood cancer. J Clin Oncol. 2010 Mar 10;28(8):1308-15. doi: 10.1200/JCO.2008.20.2267. Epub 2010 Feb 8. Erratum in: J Clin Oncol. 2010 Jul 1;28(19):3205.

name: From L'Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Gustave Roussy; University of Paris XI, Villejuif; Institut Curie; INSERM, Centre Epidémiologie sur les Causes Médicales de Décès, Paris, France; and Centre for Childhood Cancer Survivor Studies, Department of Public Health and Epidemiology, University of Birmingham, United Kingdom.

publisher: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Role of Cancer Treatment in Long-Term Overall and Cardiovascular Mortality After Childhood Cancer

ReferenceCitation: Diallo I, Haddy N, Adjadj E, Samand A, Quiniou E, Chavaudra J, Alziar I, Perret N, Guérin S, Lefkopoulos D, de Vathaire F. Frequency distribution of second solid cancer locations in relation to the irradiated volume among 115 patients treated for childhood cancer. Int J Radiat Oncol Biol Phys. 2009 Jul 1;74(3):876-83. doi: 10.1016/j.ijrobp.2009.01.040. Epub 2009 Apr 20.

title: Frequency Distribution of Second Solid Cancer Locations in Relation to the Irradiated Volume Among 115 Patients Treated for Childhood Cancer

ReferenceCitation: Nguyen F, Rubino C, Guerin S, Diallo I, Samand A, Hawkins M, Oberlin O, Lefkopoulos D, De Vathaire F. Risk of a second malignant neoplasm after cancer in childhood treated with radiotherapy: correlation with the integral dose restricted to the irradiated fields. Int J Radiat Oncol Biol Phys. 2008 Mar 1;70(3):908-15. doi: 10.1016/j.ijrobp.2007.10.034.

title: Risk of a Second Malignant Neoplasm After Cancer in Childhood Treated With Radiotherapy: Correlation With the Integral Dose Restricted to the Irradiated Fields

ReferenceCitation: Guérin S, Hawkins M, Shamsaldin A, Guibout C, Diallo I, Oberlin O, Brugières L, de Vathaire F. Treatment-adjusted predisposition to second malignant neoplasms after a solid cancer in childhood: a case-control study. J Clin Oncol. 2007 Jul 1;25(19):2833-9.

ReferenceCitation: Guérin S, Guibout C, Shamsaldin A, Dondon MG, Diallo I, Hawkins M, Oberlin O, Hartmann O, Michon J, Le Deley MC, de Vathaire F. Concomitant chemo-radiotherapy and local dose of radiation as risk factors for second malignant neoplasms after solid cancer in childhood: a case-control study. Int J Cancer. 2007 Jan 1;120(1):96-102.

ReferenceCitation: Haddy N, Le Deley MC, Samand A, Diallo I, Guérin S, Guibout C, Oberlin O, Hawkins M, Zucker JM, de Vathaire F. Role of radiotherapy and chemotherapy in the risk of secondary leukaemia after a solid tumour in childhood. Eur J Cancer. 2006 Nov;42(16):2757-64. Epub 2006 Sep 11.

ReferenceCitation: Guibout C, Adjadj E, Rubino C, Shamsaldin A, Grimaud E, Hawkins M, Mathieu MC, Oberlin O, Zucker JM, Panis X, Lagrange JL, Daly-Schveitzer N, Chavaudra J, de Vathaire F. Malignant breast tumors after radiotherapy for a first cancer during childhood. J Clin Oncol. 2005 Jan 1;23(1):197-204.

ReferenceCitation: Menu-Branthomme A, Rubino C, Shamsaldin A, Hawkins MM, Grimaud E, Dondon MG, Hardiman C, Vassal G, Campbell S, Panis X, Daly-Schveitzer N, Lagrange JL, Zucker JM, Chavaudra J, Hartman O, de Vathaire F. Radiation dose, chemotherapy and risk of soft tissue sarcoma after solid tumours during childhood. Int J Cancer. 2004 May 20;110(1):87-93.

ReferenceCitation: Rubino C, Adjadj E, Guérin S, Guibout C, Shamsaldin A, Dondon MG, Valteau-Couanet D, Hartmann O, Hawkins M, de Vathaire F. Long-term risk of second malignant neoplasms after neuroblastoma in childhood: role of treatment. Int J Cancer. 2003 Dec 10;107(5):791-6.

ReferenceCitation: Guérin S, Dupuy A, Anderson H, Shamsaldin A, Svahn-Tapper G, Moller T, Quiniou E, Garwicz S, Hawkins M, Avril MF, Oberlin O, Chavaudra J, de Vathaire F. Radiation dose as a risk factor for malignant melanoma following childhood cancer. Eur J Cancer. 2003 Nov;39(16):2379-86.

ReferenceCitation: de Vathaire F, Hardiman C, Shamsaldin A, Campbell S, Grimaud E, Hawkins M, Raquin M, Oberlin O, Diallo I, Zucker JM, Panis X, Lagrange JL, Daly-Schveitzer N, Lemerle J, Chavaudra J, Schlumberger M, Bonaïti C. Thyroid carcinomas after irradiation for a first cancer during childhood. Arch Intern Med. 1999 Dec 13-27;159(22):2713-9.

ReferenceCitation: de Vathaire F, Hawkins M, Campbell S, Oberlin O, Raquin MA, Schlienger JY, Shamsaldin A, Diallo I, Bell J, Grimaud E, Hardiman C, Lagrange JL, Daly-Schveitzer N, Panis X, Zucker JM, Sancho-Garnier H, Eschwège F, Chavaudra J, Lemerle J. Second malignant neoplasms after a first cancer in childhood: temporal pattern of risk according to type of treatment. Br J Cancer. 1999 Apr;79(11-12):1884-93.

ReferenceCitation: Little MP, de Vathaire F, Shamsaldin A, Oberlin O, Campbell S, Grimaud E, Chavaudra J, Haylock RG, Muirhead CR. Risks of brain tumour following treatment for cancer in childhood: modification by genetic factors, radiotherapy and chemotherapy. Int J Cancer. 1998 Oct 29;78(3):269-75.

ReferenceCitation: Le Vu B, de Vathaire F, Shamsaldin A, Hawkins MM, Grimaud E, Hardiman C, Diallo I, Vassal G, Bessa E, Campbell S, Panis X, Daly-Schveitzer N, Lagrange JL, Zucker JM, Eschwège F, Chavaudra J, Lemerle J. Radiation dose, chemotherapy and risk of osteosarcoma after solid tumours during childhood. Int J Cancer. 1998 Jul 29;77(3):370-7.

ReferenceCitation: de Vathaire F, Shamsaldin A, Grimaud E, Campbell S, Guerra M, Raquin M, Bessa E, Hardiman C, Jan P, Rumeau N, et al. Solid malignant neoplasms after childhood irradiation: decrease of the relative risk with time after irradiation. C R Acad Sci III. 1995 Apr;318(4):483-90.

ReferenceCitation: Pein F, Sakiroglu O, Dahan M, Lebidois J, Merlet P, Shamsaldin A, Villain E, de Vathaire F, Sidi D, Hartmann O. Cardiac abnormalities 15 years and more after adriamycin therapy in 229 childhood survivors of a solid tumour at the Institut Gustave Roussy. Br J Cancer. 2004 Jul 5;91(1):37-44.

ReferenceCitation: Guldner L, Haddy N, Pein F, Diallo I, Shamsaldin A, Dahan M, Lebidois J, Merlet P, Villain E, Sidi D, Sakiroglu O, Hartmann O, Leftakopoulos D, de Vathaire F. Radiation dose and long term risk of cardiac pathology following radiotherapy and anthracyclin for a childhood cancer. Radiother Oncol. 2006 Oct;81(1):47-56. Epub 2006 Sep 20.

ReferenceCitation: Shamsaldin A, Grimaud E, Hardiman C, Diallo I, de-Vathaire F, Chavaudra J. Dose distribution throughout the body from radiotherapy for Hodgkin's disease in childhood. Radiother Oncol. 1998 Oct;49(1):85-90.

ReferenceCitation: de Vathaire F, François P, Schlumberger M, Schweisguth O, Hardiman C, Grimaud E, Oberlin O, Hill C, Lemerle J, Flamant R. Epidemiological evidence for a common mechanism for neuroblastoma and differentiated thyroid tumour. Br J Cancer. 1992 Mar;65(3):425-8.

ReferenceCitation: de Vathaire F, François P, Hill C, Schweisguth O, Rodary C, Sarrazin D, Oberlin O, Beurtheret C, Dutreix A, Flamant R. Role of radiotherapy and chemotherapy in the risk of second malignant neoplasms after cancer in childhood. Br J Cancer. 1989 May;59(5):792-6.

ReferenceCitation: de Vathaire F, Schweisguth O, Rodary C, François P, Sarrazin D, Oberlin O, Hill C, Raquin MA, Dutreix A, Flamant R. Long-term risk of second malignant neoplasm after a cancer in childhood. Br J Cancer. 1989 Mar;59(3):448-52.

ReferenceCitation: de Vathaire F, François P, Schweisguth O, Oberlin O, Le MG. Irradiated neuroblastoma in childhood as potential risk factor for subsequent thyroid tumour. Lancet. 1988 Aug 20;2(8608):455.

ReferenceCitation: de Vathaire F, El-Fayech C, Ben Ayed FF, Haddy N, Guibout C, Winter D, Thomas-Teinturier C, Veres C, Jackson A, Pacquement H, Schlumberger M, Hawkins M, Diallo I, Oberlin O. Radiation dose to the pancreas and risk of diabetes mellitus in childhood cancer survivors: a retrospective cohort study. Lancet Oncol. 2012 Oct;13(10):1002-10. doi: 10.1016/S1470-2045(12)70323-6. Epub 2012 Aug 23.

ReferenceCitation: de Vathaire F, Haddy N, Allodji RS, Hawkins M, Guibout C, El-Fayech C, Teinturier C, Oberlin O, Pacquement H, Diop F, Kalhouche A, Benadjaoud M, Winter D, Jackson A, Bezin Mai-Quynh G, Benabdennebi A, Llanas D, Veres C, Munzer M, Nguyen TD, Bondiau PY, Berchery D, Laprie A, Deutsch E, Lefkopoulos D, Schlumberger M, Diallo I, Rubino C. Thyroid Radiation Dose and Other Risk Factors of Thyroid Carcinoma Following Childhood Cancer. J Clin Endocrinol Metab. 2015 Nov;100(11):4282-90. doi: 10.1210/jc.2015-1690. Epub 2015 Sep 1.

journal_name: The Journal of Clinical Endocrinology & Metabolism

location_facility: Centre Hospitalier Régional Universitaire Hôpital Saint-Jacques

location_facility: Centre Hospitalier Universitaire Hôpital Sud

location_facility: Hôpital d'Enfants de Margency (HEM) Croix Rouge Française

location_facility: Centre Hospitalier Universitaire Hôpial Hôtel Dieu

location_facility: Centre Régional de Lutte Contre le Cancer de Lorraine ALEXIS VAUTRIN

location_facility: Centre Hospitalier Universaitaire hôpital d'enfants

location_facility: Centre Hospitalier Universitaire Hôpital Nord

location_facility: GCS Hôpitaux pédiatriques Centre Hospitalier Universitaire Lenval

location_facility: Centre Hospitalier Universaitaire Hôpital Côte de Nacre

location_facility: Centre René Gauducheau de Nantes Atlantique

location_facility: Centre Hospital-Universitaire Hôpital Nord

location_facility: Centre Régional de Lutte Contre le Cancer Centre Léon Bérard

location_facility: Centre Hospitalier Universaitaire Hôpital mère-enfant

location_facility: Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche

location_facility: Institut d'Hématologie et Oncologie Pédiatrique


title: Evaluation of the Performance and Tolerance of the NOVATECH ® LUCIOLA TM EB Fiducial Marker During Radiotherapy Sessions in Patients Suffering From Lung Cancer: Multicenter, Post CE-mark Study

acronym: LUCIOLA

summary:
Following CE certification, this Post Market Clinical Follow-up investigates the performance and safety of using the new fiducial marker, NOVATECH® LUCIOLA™ EB, in the lung airways to monitor in real-time tumor location during radiotherapy.

At the time of insertion near the tumor, the Luciola's 3 fiducial marker arms are deployed simultaneously. Optimal detection of the fiducial marker is considered during the radiotherapy treatment.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Hospital St. Joseph, Marseille, France

location_facility: Centre de radiothérapie Francois Baclesse

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing


title: Morphological and Functional Changes in White Adipose Tissue in Nondiabetic Chronic Kidney Disease Patients

acronym: MODAIR

summary: Many metabolic disturbances, such as protein-energy wasting, inulin resistance, and dyslipidemia are common features of chronic kidney disease (CKD). However, to date, the underlying mechanisms of these disturbances remain elusive. Many in vitro studies have demonstrated that white adipose cells exhibit dysfunctions in conditions that mimics uremic environment. In good agreement, several animal experiments have reported that chronic kidney disease was associated with lipoatrophy, adipose tissue dysfunction and ectopic lipid redistribution. The goal of this protocol is to collect and study structural and metabolic properties of white adipose tissue in CKD stage V patients to evidence adipose tissue dysfunction associated with CKD. The primary outcome measure will be the cellularity of the adipose tissue (i.e. size of the adipose cells) and the secondary measure to study the gene expression profile using microarray and metabolic properties of adipose tissue (i.e. lipogenesis). To this end, 15 male adult volunteers and 15 non-diabetic and non-dialyzed CKD stage V patients, matched for age, gender and body mass index (BMI) will be recruited at the Departments of Nephrology or Urology of Lyon University Hospital (Lyon, France). The biopsies of abdominal subcutaneous white adipose tissue (2-3 g) will be performed during elective urologic surgery (i.e. peritoneal dialysis catheter for CKD patients and radical prostatectomy for non CKD patients).

status: Completed

study_completion_date_type: Actual

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Néphrologie, dialyse, hypertension artérielle - Pavillon P - Hôpital Edouard Herriot -

intervention_type: Other

status_simplified: Completed


title: Cardiac and Respiratory Prognostic Factors in Patients With Myotonic Dystrophy Type 1

summary:
Myotonic dystrophy type 1 (DM1) is the most frequent neuromuscular disease in adults. DM1 patients have an impaired prognosis (mean age of death <60 years) due to cardiac and respiratory complications.

Our primary objective was to identify cardiac and respiratory prognostic factors in DM1.

study_type: Observational

time_perspective: Retrospective

ReferenceType: derived

ReferenceCitation: Chong-Nguyen C, Wahbi K, Algalarrondo V, Bécane HM, Radvanyi-Hoffman H, Arnaud P, Furling D, Lazarus A, Bassez G, Béhin A, Fayssoil A, Laforêt P, Stojkovic T, Eymard B, Duboc D. Association Between Mutation Size and Cardiac Involvement in Myotonic Dystrophy Type 1: An Analysis of the DM1-Heart Registry. Circ Cardiovasc Genet. 2017 Jun;10(3). pii: e001526. doi: 10.1161/CIRCGENETICS.116.001526.

family: Chong-Nguyen

full_name: Caroline Chong-Nguyen

given: Caroline

sequence: first

family: Wahbi

full_name: Karim Wahbi

given: Karim

sequence: additional

family: Algalarrondo

full_name: Vincent Algalarrondo

given: Vincent

family: Bécane

full_name: Henri Marc Bécane

given: Henri Marc

family: Radvanyi-Hoffman

full_name: Hélène Radvanyi-Hoffman

family: Arnaud

full_name: Pauline Arnaud

given: Pauline

family: Furling

full_name: Denis Furling

given: Denis

family: Lazarus

full_name: Arnaud Lazarus

given: Arnaud

family: Bassez

full_name: Guillaume Bassez

given: Guillaume

family: Béhin

full_name: Anthony Béhin

given: Anthony

family: Fayssoil

full_name: Abdallah Fayssoil

given: Abdallah

family: Laforêt

full_name: Pascal Laforêt

given: Pascal

family: Stojkovic

full_name: Tanya Stojkovic

given: Tanya

family: Eymard

full_name: Bruno Eymard

given: Bruno

family: Duboc

full_name: Denis Duboc

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Circulation: Cardiovascular Genetics

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Wahbi K, Babuty D, Probst V, Wissocque L, Labombarda F, Porcher R, Bécane HM, Lazarus A, Béhin A, Laforêt P, Stojkovic T, Clementy N, Dussauge AP, Gourraud JB, Pereon Y, Lacour A, Chapon F, Milliez P, Klug D, Eymard B, Duboc D. Incidence and predictors of sudden death, major conduction defects and sustained ventricular tachyarrhythmias in 1388 patients with myotonic dystrophy type 1. Eur Heart J. 2017 Mar 7;38(10):751-758. doi: 10.1093/eurheartj/ehw569.

family: Babuty

full_name: Dominique Babuty

given: Dominique

family: Probst

full_name: Vincent Probst

family: Wissocque

full_name: Ludivine Wissocque

given: Ludivine

family: Labombarda

full_name: Fabien Labombarda

given: Fabien

ReferenceCitation: Wahbi K, Algalarrondo V, Bécane HM, Fressart V, Beldjord C, Azibi K, Lazarus A, Berber N, Radvanyi-Hoffman H, Stojkovic T, Béhin A, Laforêt P, Eymard B, Hatem S, Duboc D. Brugada syndrome and abnormal splicing of SCN5A in myotonic dystrophy type 1. Arch Cardiovasc Dis. 2013 Dec;106(12):635-43. doi: 10.1016/j.acvd.2013.08.003. Epub 2013 Oct 17.

ReferenceCitation: Wahbi K, Meune C, Porcher R, Bécane HM, Lazarus A, Laforêt P, Stojkovic T, Béhin A, Radvanyi-Hoffmann H, Eymard B, Duboc D. Electrophysiological study with prophylactic pacing and survival in adults with myotonic dystrophy and conduction system disease. JAMA. 2012 Mar 28;307(12):1292-301. doi: 10.1001/jama.2012.346. Erratum in: JAMA. 2012 Jul 25;308(4):342.

title: Electrophysiological Study With Prophylactic Pacing and Survival in Adults With Myotonic Dystrophy and Conduction System Disease


title: MRI Angiography of Physiological and Pathological Pregnancy Placentas Ex-vivo

acronym: MAPLE

summary:
Introduction:

The placenta is the organ that permits the maternal-fetal exchange of the oxygen and nutrients. The development of its vascular network occurs in the first trimester. Any deficit during this important angiogenesis procedure can lead to the dysfunction of the placental vasculature, which can potentially cause pathologies including preeclampsia (PE) and intrauterine growth restriction (IUGR). PE concerns 3% of the pregnancy in France. It can occur at any gestational age and leads to serious complications such as eclampsia, the HELLP syndrome or the retro-placental hematoma. IUGR does not only lead to the morbidity and fetal and neonatal mortality, but also has a predisposition for certain pathologies in the adulthood.

Many groups have studied the placenta vasculature at the microscopic (histological) scale. However, recent studies show that in addition to the damage at the microvasculature level, the macroscopic placental vessel architecture is also altered. Nonetheless, the origin and the etiology of this phenomenon remains unknown.

Since it is difficult to apply in-vivo imaging techniques on pregnant women due to the restriction of usage of contrast agent. Alternatively, ex-vivo MR angiography (MRA) techniques have been developed by our team and others to visualize the entire placental vasculature in a faster way (as compared to corrosion casting). Up to now, only the study of the healthy placenta is done and published. The analysis of the pathological placental vasculature (i.e. PE and IUGR cases) at different gestational age and its comparison to the physiological ones have not been conducted, which will potentially enable a better understanding of the placental vasculature pathology.

Objectives: the main objective of this study is to compare the vasculature architecture of the normal and pathological placentas (with possible alteration in the placental vasculature).

Methods and analysis: This is a monocentric, prospective, controlled but not randomized study. The investigators expect to include 100 women in Nancy. The pregnant women will be recruited when they arrived at the maternity hospital for delivery, for both the physiological and potential pathological cases. The notice of this study will be given. If no opposition is given by the subject, the placenta may be collected. This study will not collect the patient consent but only the opposition declaration will be collected.

time_perspective: Prospective

lead_sponsor: Central Hospital, Nancy, France

location_facility: Centre Hospitalier Régional Universitaire de Nancy


title: Title A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer

acronym: Python

summary: PYTHON is designed to establish the efficacy and safety of 18F-DCFPyL in comparison with that of 18F-fluorocholine, in patients with first biochemical recurrence (BCR) after initial definitive therapy (prostatectomy, external beam radiotherapy or brachytherapy) for histopathologically confirmed prostate adenocarcinoma per original diagnosis. PET/CT scans will be each interpreted by three independent masked experts who are not otherwise involved in the trial.

status: Active, not recruiting

design_allocation: Randomized

primary_purpose: Diagnostic

ipd_sharing: Undecided

lead_sponsor: Curium PET France

intervention_type: Diagnostic Test

lead_sponsor_type: industriel


title: ACCEPTABILITY AND WRITING FREQUENCY OF ADVANCED DIRECTIVES IN ONCO-DERMATOLOGY PATIENTS

acronym: PADAONCODERM

summary:
The law about advance directives is evolving but, in France, few people write it.

Te main endpoint of this research is to estimate the proportion of patients who have written their advance directives or considering doing so in onco-dermatologic population. If this rate remains low, some insights on the reasons will be able to be advanced looking at the point of view and opinion of patients about this topic.

Seconds endpoints are :

For patients against or not planning to write it, understand their reasons

Estimate the proportion of patients requesting information and understand how they would like to receive it.

Investigate a possible association between the stage of the oncological disease and the positioning of the patient concerning advance directives.

status: Unknown status

time_perspective: Cross-Sectional

status_simplified: Unknown


title: Randomized Trial to Evaluate the Safety and Efficacy of Outpatient Treatments to Reduce the Risk of Worsening in Individuals With COVID-19 With Risk Factors (COVERAGE France)

acronym: COVERAGEFrance

summary: In adults with COVID-19 without criteria for hospitalization or oxygen therapy but with risk factors for aggravation, early treatment may avoid hospitalization, indication for oxygen therapy or death. No treatment is currently validated for this indication.

primary_purpose: Treatment

ReferenceCitation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

name: Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Kreuzberger

full_name: Nina Kreuzberger

given: Nina

family: Hirsch

full_name: Caroline Hirsch

name: Transfusion Research Unit, School of Public Health and Preventive Medicine; Monash University; Melbourne Australia

family: Chai

full_name: Khai Li Chai

given: Khai Li

name: Population Health Sciences, Bristol Medical School; University of Bristol; Bristol UK

family: Tomlinson

full_name: Eve Tomlinson

given: Eve

family: Khosravi

full_name: Zahra Khosravi

given: Zahra

name: Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine; University Hospital Wuerzburg; Wuerzburg Germany

family: Popp

full_name: Maria Popp

given: Maria

family: Neidhardt

full_name: Miriam Neidhardt

given: Miriam

family: Piechotta

full_name: Vanessa Piechotta

given: Vanessa

name: Laboratory of Experimental Immunology, Institute of Virology; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Salomon

full_name: Susanne Salomon

given: Susanne

name: Jon J van Rood Center for Clinical Transfusion Research; Sanquin/Leiden University Medical Center; Leiden Netherlands

family: Valk

full_name: Sarah J Valk

given: Sarah J

family: Monsef

full_name: Ina Monsef

given: Ina

name: Department of Nephrology; Technical University of Munich, School of Medicine, Klinikum rechts der Isar; Munich Germany

family: Schmaderer

full_name: Christoph Schmaderer

given: Christoph

family: Wood

full_name: Erica M Wood

given: Erica M

name: Erasmus Medical Centre; Rotterdam Netherlands

family: So-Osman

full_name: Cynthia So-Osman

given: Cynthia

name: Systematic Review Initiative; NHS Blood and Transplant; Oxford UK

family: Roberts

full_name: David J Roberts

given: David J

family: McQuilten

full_name: Zoe McQuilten

given: Zoe

name: Haematology/Transfusion Medicine; NHS Blood and Transplant; Oxford UK

family: Estcourt

full_name: Lise J Estcourt

given: Lise J

name: Cochrane Cancer, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Skoetz

full_name: Nicole Skoetz

given: Nicole

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Duvignaud A, Lhomme E, Pistone T, Onaisi R, Sitta R, Journot V, Nguyen D, Peiffer-Smadja N, Crémer A, Bouchet S, Darnaud T, Poitrenaud D, Piroth L, Binquet C, Michel JF, Lefèvre B, Lebeaux D, Lebel J, Dupouy J, Roussillon C, Gimbert A, Wittkop L, Thiébaut R, Orne-Gliemann J, Joseph JP, Richert L, Anglaret X, Malvy D; COVERAGE study group. Home Treatment of Older People with Symptomatic SARS-CoV-2 Infection (COVID-19): A structured Summary of a Study Protocol for a Multi-Arm Multi-Stage (MAMS) Randomized Trial to Evaluate the Efficacy and Tolerability of Several Experimental Treatments to Reduce the Risk of Hospitalisation or Death in outpatients aged 65 years or older (COVERAGE trial). Trials. 2020 Oct 13;21(1):846. doi: 10.1186/s13063-020-04619-1.

family: Duvignaud

full_name: Alexandre Duvignaud

given: Alexandre

family: Lhomme

full_name: Edouard Lhomme

given: Edouard

family: Pistone

location_facility:
CNGE
CHU de Dijon-Bourgogne
Groupe hospitalier Paris Saint Joseph
Université Angers
CHU de Montpellier
Université Nantes
Bordeaux university Hospital
CH de Bastia
CHRU de Nancy
CHU de Toulouse
IMEA


title: Impact of Hydroxocobalamine on Outcome of Smoke Inhalation Injury Admitted to the ICU

acronym: COB-AKI

summary: In Europe, hydroxocobalamin (cyanokit) has been used for suspicion of cyanide intoxication associated with the inhalation of fire smoke (1). However, the impact of hydroxocobalamin on outcome has never been thoroughly evaluated. While hydroxocobalamin has long been presented as being side-effect free, recent data suggest that in patients with severe burns, its use was associated with the occurrence of acute renal failure by intra tubular precipitation of oxalate crystals (2, 3). The purpose of this observational study is to investigate the association between use of hydroxocobalamin and outcome after smoke inhalation.

ReferenceType: background

ReferenceCitation: 1. Anseeuw K, Delvau N, Burillo-Putze G, et al.: Cyanide poisoning by fire smoke inhalation: a European expert consensus. Eur J Emerg Med 2013; 20:2-9 2. for the PRONOBURN Study Group, Legrand M, Michel T, et al.: Risk of oxalate nephropathy with the use of cyanide antidote hydroxocobalamin in critically ill burn patients. Intensive Care Medicine 2016; 42:1080-1081 3. Legrand M, Michel T: Empiric use of hydroxocobalamin in patients with smoke inhlation injury: Not so fast! Burns 2017; 43:886

ReferenceCitation: Dépret F, Hoffmann C, Daoud L, Thieffry C, Monplaisir L, Creveaux J, Annane D, Parmentier E, Mathieu D, Wiramus S, Demeure DIt Latte D, Kpodji A, Textoris J, Robin F, Klouche K, Pontis E, Schnell G, Barbier F, Constantin JM, Clavier T, du Cheyron D, Terzi N, Sauneuf B, Guerot E, Lafon T, Herbland A, Megarbane B, Leclerc T, Mallet V, Pirracchio R, Legrand M. Association between hydroxocobalamin administration and acute kidney injury after smoke inhalation: a multicenter retrospective study. Crit Care. 2019 Dec 23;23(1):421. doi: 10.1186/s13054-019-2706-0.

family: Dépret

full_name: François Dépret

given: François

family: Hoffmann

full_name: Clément Hoffmann

given: Clément

family: Daoud

full_name: Laura Daoud

given: Laura

family: Thieffry

full_name: Camille Thieffry

given: Camille

family: Monplaisir

full_name: Laure Monplaisir

given: Laure

family: Creveaux

full_name: Jules Creveaux

given: Jules

family: Annane

full_name: Djillali Annane

given: Djillali

family: Parmentier

full_name: Erika Parmentier

given: Erika

family: Mathieu

full_name: Daniel Mathieu

given: Daniel

family: Wiramus

full_name: Sandrine Wiramus

given: Sandrine

family: Demeure DIt Latte

full_name: Dominique Demeure DIt Latte

given: Dominique

family: Kpodji

full_name: Aubin Kpodji

given: Aubin

family: Textoris

full_name: Julien Textoris

given: Julien

family: Robin

full_name: Florian Robin

given: Florian

family: Klouche

full_name: Kada Klouche

given: Kada

family: Pontis

full_name: Emmanuel Pontis

given: Emmanuel

family: Schnell

full_name: Guillaume Schnell

given: Guillaume

family: Barbier

full_name: François Barbier

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

family: Clavier

full_name: Thomas Clavier

given: Thomas

family: du Cheyron

full_name: Damien du Cheyron

given: Damien

family: Terzi

full_name: Nicolas Terzi

given: Nicolas

family: Sauneuf

full_name: Bertrand Sauneuf

given: Bertrand

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - INSU


title: Genetic Susceptibility to Radiation Induced Thyroid Cancer

summary:
Case control on thyroid cancer occuring in a cohort of 7300 subjects treated during their childhood, mostly by radiotherapy, for a skin Angioma at Gustave Roussy, Villejuif France between 1947 and 1973.

This case control study, which is included in a larger european project, aims to investigate the DNA variant interacting with the risk of radiation induced thyroid cancer after irradiation.

The sutdy is planed to include about 30 cases and 30 controls. Matching criteria are date of birth, gender, and age at irradiation.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France


title: Effect of Cannabis Consumption on Sperm Nuclear Quality in Infertile Men : a Prospective Exposed / Unexposed Study

acronym: CANNASPERM

summary: Lifestyle and environmental factors can disrupt development and testicular function. In France, cannabis is the most widely used illicit substance and about 8% of adults between 18 and 64 years smoke cannabis at least once a year, and mostly men under 45 years. Endocannabinoids are lipid mediators that share some effects with the active ingredients of cannabis. Cannabis and endocannabinoids act via two types of endogenous receptors which were detected at different levels of the reproductive system and are involved in the central and local regulation of the gonad. Cannabis use may alter the normal regulation of the endocannabinoid system. In males, the regulation of the endocannabinoid system is critical for Sertoli and Leydig cells functions, germ cell differentiation, maturation of sperm nucleus and sperm quality. The cannabis can have a negative impact on sperm parameters, capacitation and acrosome reaction. Cannabinoids may decrease testosterone synthesis and induce apoptosis of Sertoli cells. Studies on the effect of cannabinoids on male fertility are scarce or nonexistent in infertile men because of ethical considerations and bias due to consumption often underreported. Investigators hypothesized that cannabis use may alter sperm nuclear quality. Investigators want to explore this hypothesis conducting a multicentric prospective study exposed/non-exposed in infertile men who are consulting for Medically Assisted Reproductive Technologies (ART). To reach this study, it is planned to include a total of 200 subjects taking into account any exclusions.

lead_sponsor: University Hospital, Rouen

location_facility:
Lille University Hospital
Rouen University Hospital
Caen University Hospital

intervention_type: Procedure


title: Attention and Grouping of Visual Information: What is Disturbed in Patients With Schizophrenia?

summary: The main objective of the study is to contribute to a better understanding of the physiopathology of schizophrenia, by studying causal relationships between cognitive deficits and the neurobiological basis for these deficits. Processing visual information involves both automatic grouping processes and control processes. Automatic grouping processes allow the building of a global configuration from local contour information. It is necessary in order to recognize objects. Control processes allow tending to and prioritizing information parts. The paradigm the investigators use allows to dissociate these processes, and is used in order to characterize the impairments observed in patients with schizophrenia. It is adapted to fMRI in order to explore the neurobiological basis of the deficits. The investigators will examine whether functional disconnectivity between activated areas subtend the impairments observed in patients.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Inserm U666 - Département de Psychiatrie, Hôpitaux Universitaires de Strasbourg


title: Anticipation and Detection of Heart Failure Decompensation With Automatic Treatment of Informations Derived From Non Intrusive Sensors and Devices

acronym: e-INCA

summary:
Heart failure (HF) is a serious chronic disease with frequent readmissions, some of which can be prevented by early action. The management of HF is complex: long, often difficult and costly. In France, nearly one million people suffer from HF and 120,000 new cases are diagnosed every year. With the aging population, this number will continue to evolve and become a real public health problem. Within 10 to 20 years ahead, WHO projects that heart failure in either the 3 most common diseases in industrialized countries.

The objective of the project is to test an intelligent platform for monitoring at home, using non-intrusive sensors, patients with heart failure, particularly those with stage II and III NYHA. It will assist the medical automating the processing of information from these sensors to detect and report an early stage risk situations.

Patient monitoring, by a system of telemedicine tools associated with motivation and education helps significantly reduce the number of days of hospitalization becomes important when the patient is hospitalized for acute HF.

location_facility: Service de Médecine Interne, diabète et maladies métaboliques - Médicale B


title: Assessment of the Contribution of Hypnosis in the Tolerance of the Bronchoscopy

acronym: FIBROHYPNOSE

summary:
Bronchoscopy is an examination performed routinely in pulmonology. This exam is considered as uncomfortable by nearly 60% of patients, especially due to respiratory blocking sensation, cough and nausea it causes, despite the use of a local anesthetic. Conversely, this examination is rarely performed under general anesthesia in hospitals in France, because it lengthens the duration of the procedure, increases its cost and can be dangerous for the respiratory failure patient.

Hypnosis is an altered state of consciousness between wakefulness and sleep, which can cause the patient to ignore the reality in which he is focusing his attention on his imagination, reducing his anxiety, his painful or unpleasant perceptions and their memorization.

The hypnosis benefit has already been evaluated in the control of pain and anxiety in many medical situations, surgical, obstetric and dental. In endoscopy, the results are mixed. In bronchoscopy, hypnosis has, to our knowledge, not been evaluated.

In a preliminary study in the endoscopy unit of the Hospital Saint Joseph, involving 66 patients, investigators showed that bronchoscopy was poorly tolerated in more than half of patients and that this poor tolerance was correlated to the level anxiety of patients, but 75% of patients surveyed would prefer the waning redo the examination in the same conditions if their health required it, rather than using a general anesthetic. Investigators then hypothesized that hypnosis would improve tolerance bronchoscopy under local anesthesia, without the need for general anesthesia.

primary_purpose: Health Services Research

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Cohorte ANRS CO5 "Cohorte Nationale VIH2"

acronym: ANRS CO VIH2

summary: The HIV2 study is an open cohort of prospective, multicentric, national observation. The main objective is to study HIV-2 infection in adult patients followed in France.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Hopital du Kremlin Bicêtre Service de médecine interne

location_facility: Service de Medecine Interne Hopital Antoine Beclere

location_facility: Service de Médecine interne - Centre Hospitalier Intercommunal

location_facility: Hôpital Bretonneau - Service des Maladies Infectieuses

location_facility: Service de Medecine Interne Hopital Cochin

intervention_type: Drug


title: Impact of front-of Pack Nutrition Labels on Purchase Intentions in an Online Supermarket-A Series of Randomized Trials

acronym: SUPERNET

summary:
Front-Of-Pack (FOP) nutrition labelling, providing simplified information on nutritional content at a glance, in order to help consumer make informed choices, has been identified as of major interest by public health specialists of many countries. French health authorities are currently considering the endorsement of a FOP nutrition label, but no specific format has yet been determined. A more simplified FOP nutrition label has been put forward in France, the 5-Colour Nutrition Label (5-CNL). Recent data suggests that the 5-CNL FOP label is well perceived and understood by consumers. The introduction of a FOP nutrition labelling system has been identified as challenging in certain population groups, due to their lower level of nutrition knowledge and unhealthier diets.

The aim of the investigators is to evaluate the impact of FOP nutrition labels on the nutritional quality of the shopping cart in an online experimental supermarket in various nutritionally at-risk populations. Two FOP systems will be tested to a control situation without FOP labelling: the Reference Intakes (RI), currently in use by some manufacturers and present in a portion of food products sold in France, and the 5-Colour Nutrition Label (5-CNL).

Three 3 arm parallel arm randomized trials are designed, each targeting a specific population. The methodology and interventions are identical across trials. Trials will be conducted in: 1) Working adults between 30-50 years old with low income, 2) Students and 3) Older subjects with identified chronic diseases. The intervention consists in the application of FOP nutrition labels on all food products, either the RI label, currently in use in some products in France, and the 5-CNL label. A control situation with no FOP will also be used. Participants will be asked to perform a shopping session in an experimental online supermarket, in one of the three experimental conditions described. The main outcome will be the overall nutritional quality of the shopping cart, assessed using the mean Food Standards Agency Nutrient profiling system score of the items in the shopping cart.

ReferenceCitation: Egnell M, Galan P, Fialon M, Touvier M, Péneau S, Kesse-Guyot E, Hercberg S, Julia C. The impact of the Nutri-Score front-of-pack nutrition label on purchasing intentions of unprocessed and processed foods: post-hoc analyses from three randomized controlled trials. Int J Behav Nutr Phys Act. 2021 Mar 17;18(1):38. doi: 10.1186/s12966-021-01108-9.

family: Egnell

full_name: Manon Egnell

given: Manon

family: Galan

full_name: Pilar Galan

given: Pilar

family: Fialon

full_name: Morgane Fialon

given: Morgane

family: Touvier

full_name: Mathilde Touvier

given: Mathilde

family: Péneau

full_name: Sandrine Péneau

family: Kesse-Guyot

full_name: Emmanuelle Kesse-Guyot

given: Emmanuelle

family: Hercberg

full_name: Serge Hercberg

given: Serge

family: Julia

full_name: Chantal Julia

given: Chantal

bso_classification: Biology (fond.)

currency_apc_doaj: GBP

journal_name: International Journal of Behavioral Nutrition and Physical Activity

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Egnell M, Boutron I, Péneau S, Ducrot P, Touvier M, Galan P, Buscail C, Porcher R, Ravaud P, Hercberg S, Kesse-Guyot E, Julia C. Randomised controlled trial in an experimental online supermarket testing the effects of front-of-pack nutrition labelling on food purchasing intentions in a low-income population. BMJ Open. 2021 Feb 8;11(2):e041196. doi: 10.1136/bmjopen-2020-041196.

family: Boutron

full_name: Isabelle Boutron

given: Isabelle

family: Ducrot

full_name: Pauline Ducrot

given: Pauline

family: Buscail

full_name: Camille Buscail

given: Camille

family: Porcher

full_name: Raphaël Porcher

given: Raphaël

family: Ravaud

full_name: Philippe Ravaud

given: Philippe

location_facility: Equipe de Recherche en Epidémiologie Nutritionnelle


title: Etiosarc: Study of the Environmental Aetiology (Environment, Occupations and Lifestyle) of Sarcomas (Soft Tissue, Visceral and Bone) From a Multicenter French Population-based Case-control Study Among Adults.

acronym: ETIOSARC

summary:
Introduction: Sarcomas are rare tumors of connective tissue. The exact overall incidence of sarcomas is unknown due to diagnostic difficulties and the various histological subtypes (over 80 subtypes). However, the apparent increasing incidence of sarcomas suggests environmental causes such as pesticides. Except for some specific factors (i.e. ionizing radiation, vinyl chloride, dioxin, and genetic predispositions) the scientific knowledge on the aetiology of sarcomas is sparse and inconsistent. France is a particularly appropriate country to set up a study investigating the causes of sarcoma occurrence due to the French organization in treatment and care of sarcoma patients, which is highly structured and revolved around national expert networks. The main objective of the ETIOSARC project is to study the role of lifestyle, environmental and occupational factors in the occurrence of sarcomas among adults from a multicentric population-based case-control study.

Methods and analysis: Cases will be all incident cases (older than 18 years old) identified in 15 districts of France covered by a cancer registry and/or a reference center in sarcoma's patient care over a three-year period with an inclusion start date ranging from the 1st October 2018 to the 1st January 2020 and histologically confirmed by a second review of the diagnosis. Two controls will be individually-matched by sex, age (5-years group), and districts of residence and randomly selected from electoral list. A standardized questionnaire will be administered by a trained interviewer in order to gather information about occupational and residential history, demographic and socioeconomic characteristics and lifestyle factors. At the end of the interview, a saliva sample will be systematically proposed.

This study will permit to validate or not already suspected risk factors for sarcomas such as phenoxyherbicides, chlorophenol and to generate new hypothesis to increase our understanding about the genetic and environmental contributions in the carcinogenicity process.

ReferenceCitation: Alexandrov LB, Stratton MR. Mutational signatures: the patterns of somatic mutations hidden in cancer genomes. Curr Opin Genet Dev. 2014 Feb;24:52-60. doi: 10.1016/j.gde.2013.11.014. Epub 2013 Dec 29. Review.

ReferenceCitation: Bisanti L, Maggini M, Raschetti R, Alegiani SS, Ippolito FM, Caffari B, Segnan N, Ponti A. Cancer mortality in ethylene oxide workers. Br J Ind Med. 1993 Apr;50(4):317-24.

ReferenceCitation: Blair A, Zahm SH. Agricultural exposures and cancer. Environ Health Perspect. 1995 Nov;103 Suppl 8:205-8. Review.

ReferenceCitation: Briggs NC, Levine RS, Hall HI, Cosby O, Brann EA, Hennekens CH. Occupational risk factors for selected cancers among African American and White men in the United States. Am J Public Health. 2003 Oct;93(10):1748-52.

ReferenceCitation: Burningham Z, Hashibe M, Spector L, Schiffman JD. The epidemiology of sarcoma. Clin Sarcoma Res. 2012 Oct 4;2(1):14. doi: 10.1186/2045-3329-2-14.

ReferenceCitation: Downs TD, Crane MM, Kim KW. Mortality among workers at a butadiene facility. Am J Ind Med. 1987;12(3):311-29.

ReferenceCitation: Ducimetière F, Lurkin A, Ranchère-Vince D, Decouvelaere AV, Péoc'h M, Istier L, Chalabreysse P, Muller C, Alberti L, Bringuier PP, Scoazec JY, Schott AM, Bergeron C, Cellier D, Blay JY, Ray-Coquard I. Incidence of sarcoma histotypes and molecular subtypes in a prospective epidemiological study with central pathology review and molecular testing. PLoS One. 2011;6(8):e20294. doi: 10.1371/journal.pone.0020294. Epub 2011 Aug 3.

family: Ducimetière

full_name: Françoise Ducimetière

given: Françoise

family: Lurkin

full_name: Antoine Lurkin

given: Antoine

family: Ranchère-Vince

full_name: Dominique Ranchère-Vince

given: Dominique

family: Decouvelaere

full_name: Anne-Valérie Decouvelaere

given: Anne-Valérie

family: Péoc'h

full_name: Michel Péoc'h

given: Michel

family: Istier

full_name: Luc Istier

given: Luc

family: Chalabreysse

full_name: Philippe Chalabreysse

family: Muller

full_name: Christine Muller

given: Christine

family: Alberti

full_name: Laurent Alberti

given: Laurent

family: Bringuier

full_name: Pierre-Paul Bringuier

given: Pierre-Paul

family: Scoazec

full_name: Jean-Yves Scoazec

given: Jean-Yves

family: Schott

full_name: Anne-Marie Schott

given: Anne-Marie

family: Bergeron

full_name: Christophe Bergeron

given: Christophe

family: Cellier

full_name: Dominic Cellier

given: Dominic

family: Blay

full_name: Jean-Yves Blay

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

currency_apc_doaj: USD

journal_name: PLoS ONE

evidence: oa repository (via OAI-PMH doi match)

repository_institution: PubMed Central - Europe PMC

title: Incidence of Sarcoma Histotypes and Molecular Subtypes in a Prospective Epidemiological Study with Central Pathology Review and Molecular Testing

ReferenceCitation: Ducimetière F, Lurkin A, Ranchère-Vince D, Decouvelaere AV, Isaac S, Claret-Tournier C, Suignard Y, Salameire D, Cellier D, Alberti L, Bringuier PP, Blay JY, Ray-Coquard I. [Incidence rate, epidemiology of sarcoma and molecular biology. Preliminary results from EMS study in the Rhône-Alpes region]. Bull Cancer. 2010 Jun;97(6):629-41. doi: 10.1684/bdc.2010.1117. Review. French.

ReferenceCitation: Eriksson M, Hardell L, Adami HO. Exposure to dioxins as a risk factor for soft tissue sarcoma: a population-based case-control study. J Natl Cancer Inst. 1990 Mar 21;82(6):486-90.

ReferenceCitation: Grimalt JO, Sunyer J, Moreno V, Amaral OC, Sala M, Rosell A, Anto JM, Albaiges J. Risk excess of soft-tissue sarcoma and thyroid cancer in a community exposed to airborne organochlorinated compound mixtures with a high hexachlorobenzene content. Int J Cancer. 1994 Jan 15;56(2):200-3.

ReferenceCitation: Guillou L, Aurias A. Soft tissue sarcomas with complex genomic profiles. Virchows Arch. 2010 Feb;456(2):201-17. doi: 10.1007/s00428-009-0853-4. Review.

ReferenceCitation: Hardell L, Eriksson M. The association between soft tissue sarcomas and exposure to phenoxyacetic acids. A new case-referent study. Cancer. 1988 Aug 1;62(3):652-6.

ReferenceCitation: Hoar SK, Blair A, Holmes FF, Boysen CD, Robel RJ, Hoover R, Fraumeni JF Jr. Agricultural herbicide use and risk of lymphoma and soft-tissue sarcoma. JAMA. 1986 Sep 5;256(9):1141-7. Erratum in: JAMA 1986 Dec 26;256(24):3351.

ReferenceCitation: Hoar Zahm S, Blair A, Holmes FF, Boysen CD, Robel RJ. A case-referent study of soft-tissue sarcoma and Hodgkin's disease. Farming and insecticide use. Scand J Work Environ Health. 1988 Aug;14(4):224-30.

ReferenceCitation: Hoppin JA, Tolbert PE, Flanders WD, Zhang RH, Daniels DS, Ragsdale BD, Brann EA. Occupational risk factors for sarcoma subtypes. Epidemiology. 1999 May;10(3):300-6.

ReferenceCitation: Hossain A, McDuffie HH, Bickis MG, Pahwa P; Cross Canada Study of Pesticides and Health Researchers. Case-control study on occupational risk factors for soft-tissue sarcoma. J Occup Environ Med. 2007 Dec;49(12):1386-93. doi: 10.1097/JOM.0b013e318157d2f2.

ReferenceCitation: Howe HL, Wingo PA, Thun MJ, Ries LA, Rosenberg HM, Feigal EG, Edwards BK. Annual report to the nation on the status of cancer (1973 through 1998), featuring cancers with recent increasing trends. J Natl Cancer Inst. 2001 Jun 6;93(11):824-42.

ReferenceCitation: IARC (2012). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 100. A review of human carcinogens, part D: radiation. Lyon, IARC (International Agency for Research on Cancer)

ReferenceCitation: IARC (2012). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 100. A review of human carcinogens, part F: chemical agents and related occupations. Lyon, IARC (International Agency for Research on Cancer)

ReferenceCitation: Karanian M, Coindre JM. [Fourth edition of WHO classification tumours of soft tissue]. Ann Pathol. 2015 Jan;35(1):71-85. doi: 10.1016/j.annpat.2014.11.003. Epub 2014 Dec 17. French.

ReferenceCitation: Kogevinas M, Kauppinen T, Winkelmann R, Becher H, Bertazzi PA, Bueno-de-Mesquita HB, Coggon D, Green L, Johnson E, Littorin M, et al. Soft tissue sarcoma and non-Hodgkin's lymphoma in workers exposed to phenoxy herbicides, chlorophenols, and dioxins: two nested case-control studies. Epidemiology. 1995 Jul;6(4):396-402.

ReferenceCitation: Landrigan PJ. Critical assessment of epidemiologic studies on the human carcinogenicity of 1,3-butadiene. Environ Health Perspect. 1990 Jun;86:143-7. Review.

ReferenceCitation: Lurkin A, Ducimetière F, Vince DR, Decouvelaere AV, Cellier D, Gilly FN, Salameire D, Biron P, de Laroche G, Blay JY, Ray-Coquard I. Epidemiological evaluation of concordance between initial diagnosis and central pathology review in a comprehensive and prospective series of sarcoma patients in the Rhone-Alpes region. BMC Cancer. 2010 Apr 19;10:150. doi: 10.1186/1471-2407-10-150.

ReferenceCitation: Mathoulin-Pélissier S, Chevreau C, Bellera C, Bauvin E, Savès M, Grosclaude P, Albert S, Goddard J, Le Guellec S, Delannes M, Bui BN, Mendiboure J, Stoeckle E, Coindre JM, Kantor G, Kind M, Cowppli-Bony A, Hoppe S, Italiano A. Adherence to consensus-based diagnosis and treatment guidelines in adult soft-tissue sarcoma patients: a French prospective population-based study. Ann Oncol. 2014 Jan;25(1):225-31. doi: 10.1093/annonc/mdt407. Epub 2013 Nov 26.

ReferenceCitation: Merletti F, Richiardi L, Bertoni F, Ahrens W, Buemi A, Costa-Santos C, Eriksson M, Guénel P, Kaerlev L, Jöckel KH, Llopis-Gonzalez A, Merler E, Miranda A, Morales-Suárez-Varela MM, Olsson H, Fletcher T, Olsen J. Occupational factors and risk of adult bone sarcomas: a multicentric case-control study in Europe. Int J Cancer. 2006 Feb 1;118(3):721-7.

ReferenceCitation: Pahwa P, McDuffie HH, Dosman JA, Robson D, McLaughlin JR, Spinelli JJ, Fincham S. Exposure to animals and selected risk factors among Canadian farm residents with Hodgkin's disease, multiple myeloma, or soft tissue sarcoma. J Occup Environ Med. 2003 Aug;45(8):857-68.

ReferenceCitation: Ray-Coquard I, Montesco MC, Coindre JM, Dei Tos AP, Lurkin A, Ranchère-Vince D, Vecchiato A, Decouvelaere AV, Mathoulin-Pélissier S, Albert S, Cousin P, Cellier D, Toffolatti L, Rossi CR, Blay JY. Sarcoma: concordance between initial diagnosis and centralized expert review in a population-based study within three European regions. Ann Oncol. 2012 Sep;23(9):2442-2449. doi: 10.1093/annonc/mdr610. Epub 2012 Feb 13.

ReferenceCitation: Sathiakumar N, Delzell E, Austin H, Cole P. A follow-up study of agricultural chemical production workers. Am J Ind Med. 1992;21(3):321-30.

ReferenceCitation: Savage SA, Mirabello L, Wang Z, Gastier-Foster JM, Gorlick R, Khanna C, Flanagan AM, Tirabosco R, Andrulis IL, Wunder JS, Gokgoz N, Patiño-Garcia A, Sierrasesúmaga L, Lecanda F, Kurucu N, Ilhan IE, Sari N, Serra M, Hattinger C, Picci P, Spector LG, Barkauskas DA, Marina N, de Toledo SR, Petrilli AS, Amary MF, Halai D, Thomas DM, Douglass C, Meltzer PS, Jacobs K, Chung CC, Berndt SI, Purdue MP, Caporaso NE, Tucker M, Rothman N, Landi MT, Silverman DT, Kraft P, Hunter DJ, Malats N, Kogevinas M, Wacholder S, Troisi R, Helman L, Fraumeni JF Jr, Yeager M, Hoover RN, Chanock SJ. Genome-wide association study identifies two susceptibility loci for osteosarcoma. Nat Genet. 2013 Jul;45(7):799-803. doi: 10.1038/ng.2645. Epub 2013 Jun 2.

ReferenceCitation: Smith JG, Christophers AJ. Phenoxy herbicides and chlorophenols: a case control study on soft tissue sarcoma and malignant lymphoma. Br J Cancer. 1992 Mar;65(3):442-8.

ReferenceCitation: Toro JR, Travis LB, Wu HJ, Zhu K, Fletcher CD, Devesa SS. Incidence patterns of soft tissue sarcomas, regardless of primary site, in the surveillance, epidemiology and end results program, 1978-2001: An analysis of 26,758 cases. Int J Cancer. 2006 Dec 15;119(12):2922-30.

ReferenceCitation: Wibmer C, Leithner A, Zielonke N, Sperl M, Windhager R. Increasing incidence rates of soft tissue sarcomas? A population-based epidemiologic study and literature review. Ann Oncol. 2010 May;21(5):1106-11. doi: 10.1093/annonc/mdp415. Epub 2009 Oct 25. Review.

ReferenceCitation: Wingren G, Fredrikson M, Brage HN, Nordenskjöld B, Axelson O. Soft tissue sarcoma and occupational exposures. Cancer. 1990 Aug 15;66(4):806-11.

ReferenceCitation: Woods JS, Polissar L, Severson RK, Heuser LS, Kulander BG. Soft tissue sarcoma and non-Hodgkin's lymphoma in relation to phenoxyherbicide and chlorinated phenol exposure in western Washington. J Natl Cancer Inst. 1987 May;78(5):899-910.

ReferenceCitation: Lacourt A, Amadéo B, Gramond C, Marrer E, Plouvier S, Baldi I, Blay JY, Coindre JM, de Pinieux G, Gouin F, Italiano A, Le Cesne A, Le Loarer F, Monnereau A, Pellegrin I, Penel N, Ray-Coquard I, Toulmonde M, Ducimetière F, Mathoulin-Pélissier S; Etiosarc study group. ETIOSARC study : environmental aetiology of sarcomas from a French prospective multicentric population-based case-control study-study protocol. BMJ Open. 2019 Jun 18;9(6):e030013. doi: 10.1136/bmjopen-2019-030013.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

title: ETIOSARC study : environmental aetiology of sarcomas from a French prospective multicentric population-based case–control study—study protocol

ipd_sharing_description: Anonymized individual participant data for both cases and controls will be made available under request to the principal investigator

location_facility:
Centre Léon Bérard
Centre François Baclesse
Centre Oscar Lambret
CHU Dupuytren
Institut régional du Cancer Montpellier
CHRU
Institut Bergonié
CHU
Institut Gustave Roussy


type: Registry Identifier

title: Research on Severe Asthma

acronym: RAMSES

summary:
The French Society for Respiratory diseases (SPLF), through its Asthma and Allergy working group (G2A), wishes to set up a national cohort of severe asthma patients to describe this population and the use of step 4 and 5 treatment. This study also meets the demand for post - registration studies required by the Health Authorities for biotherapies and bronchial thermoplasty.

Other European or international cohorts of asthmatic patients exist and RAMSES could contribute to data sharing initiatives.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


type: Other Identifier

title: Diagnostic and Prognostic Value of New Biomarkers in Patients With Heart Disease

summary: The objective of this work is to investigate and then to sequence new biomarkers in the plasma of patients presenting with dyspnea secondary or not to heart failure, and study their diagnostic and prognostic value.

ReferenceCitation: Badoz M, Arrigo M, Mogenet AC, Sadoune M, Meneveau N, Mebazaa A, Seronde MF. Assessment of successful percutaneous mitral commissurotomy by MRproANP and sCD146. BMC Cardiovasc Disord. 2020 Apr 5;20(1):157. doi: 10.1186/s12872-020-01435-y.

family: Badoz

full_name: Marc Badoz

given: Marc

family: Arrigo

full_name: Mattia Arrigo

given: Mattia

family: Mogenet

full_name: Anne-Claire Mogenet

given: Anne-Claire

family: Sadoune

full_name: Malha Sadoune

given: Malha

family: Meneveau

full_name: Nicolas Meneveau

given: Nicolas

family: Mebazaa

full_name: Alexandre Mebazaa

given: Alexandre

family: Seronde

full_name: Marie-France Seronde

given: Marie-France

journal_name: BMC Cardiovascular Disorders

ReferenceCitation: Van Aelst LNL, Abraham M, Sadoune M, Lefebvre T, Manivet P, Logeart D, Launay JM, Karim Z, Puy H, Cohen-Solal A. Iron status and inflammatory biomarkers in patients with acutely decompensated heart failure: early in-hospital phase and 30-day follow-up. Eur J Heart Fail. 2017 Aug;19(8):1075-1076. doi: 10.1002/ejhf.837. Epub 2017 May 17.

name: Department of Cardiovascular Sciences; Catholic University of Leuven; Leuven Belgium

family: Van Aelst

full_name: Lucas N.L. Van Aelst

given: Lucas N.L.

name: Department of Cardiology; Lariboisière Hospital; Paris France

name: U942 INSERM BIOCANVAS (Biomarqueurs Cardiovasculaires); Paris France

family: Abraham

full_name: Marjorie Abraham

given: Marjorie

name: INSERM U1149, Centre de Recherche sur l'Inflammation; University of Paris VII Denis Diderot; Paris France

name: Laboratory of Excellence; GR-Ex Imagine Institute; Paris France

family: Lefebvre

full_name: Thibaud Lefebvre

given: Thibaud

name: Medical Biochemistry and Molecular Biology; Lariboisière Hospital; Paris France

name: Biossip Analytical Platform, Centre for Biological Resources BB-0033-00064; Lariboisière Hospital; Paris France

family: Manivet

full_name: Philippe Manivet

name: Department of Cardiology; University of Paris VII Denis Diderot; Paris France

family: Logeart

full_name: Damien Logeart

given: Damien

family: Launay

full_name: Jean-Marie Launay

given: Jean-Marie

family: Karim

full_name: Zoubida Karim

given: Zoubida

family: Puy

full_name: Hervé Puy

given: Hervé

ReferenceCitation: Vodovar N, Séronde MF, Laribi S, Gayat E, Lassus J, Boukef R, Nouira S, Manivet P, Samuel JL, Logeart D, Ishihara S, Cohen Solal A, Januzzi JL Jr, Richards AM, Launay JM, Mebazaa A; GREAT Network. Post-translational modifications enhance NT-proBNP and BNP production in acute decompensated heart failure. Eur Heart J. 2014 Dec 21;35(48):3434-41. doi: 10.1093/eurheartj/ehu314. Epub 2014 Aug 24.


title: Medico-social Description of Seniors Living With HIV, Associated With a Qualitative Survey on Their Care in the Paris Region Structures

acronym: VIAGE

summary:
This study is part of a national vision to fight against serophobia and support society towards more ethical and benevolent practices vis-à-vis aging and specific populations.

The main objective of this study is to assess over the past five years the prevalence of people living with the Human Immunodeficiency Virus (HIV) aged 60 years and over and its evolution within the Paris Region medico-social structures

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Gérond'if


title: Study of KRAS Mutation in 250 Cases of Colorectal Carcinoma and Study of the Incidence of the Disease in Martinique, From 2007 to 2009

acronym: KRAS

summary:
There is no data at present concerning the KRAS mutation in patients from Martinique with colorectal cancer. Despite the fact that the incidence of this disease continues to increase there is no recent data to confirm it. This study has a descriptive purpose, allowing a comparison of the population from Martinique to other populations.
A study of incidence of colorectal cancer, overseen by the Association from Martinique for the Epidemiological Search on Cancer (AMREC), also leads to a better knowledge of the local characteristics of the colorectal cancer.
These two descriptive characteristics of colorectal cancer in Martinique will be useful data for the health professionals to provide their patients better care.

lead_sponsor: University Hospital Center of Martinique

location_facility: Laboratoire de Virologie - CHU de Fort de France


title: Study of Catalytic Antibodies in a Cohort Population of Martinique

summary:
The Martinique island (French West-Indies) is an area of high prevalence and incidence for Systemic Lupus Erythematosus (SLE), respectively 64,2/ 100000 and 4,7/ 100000. In many cases, this disease concerns Afro Caribbean women, whose auto-antibodies are excessively high; also, organic damages are frequent. The disease can be fatal.
Studies have shown that some cytotoxic auto-antibodies may have a responsibility in the hydrolysing of DNA. This study will focus on the DNA activity and also on the overwhelm hydrolase activity dealing with the Lupus disease in order to measure the link between the disease activity and the catalytic activity. Patients concerned by this study will be Martinique people.

location_facility: Centre Hospitalier Universitaire de Fort de France


title: Transthoracic Echocardiographic Assessment of the Superior Vena Cava Flow Respiratory Variation in ICU Intubated Patients

acronym: CAVSUP

summary:
Acute circulatory failure is frequent, affecting up to one-third of patients admitted to intensive care units (ICU). Monitoring hemodynamics and cardiac function is therefore a major concern. Analysis of respiratory diameter variations of the superior vena cava (SVC) is easily obtained with transesophageal echocardiography (TEE) and is helpful to assess fluid responsiveness.

Transthoracic echocardiography (TTE) exploration of the SVC is not used in routine. Recently, micro-convex ultrasound transducers have been marketed and these may be of use for non-invasive SVC flow examination. However, analysis of diameter variations of the SVC with TTE does not seem to be possible since the approach from the supraclavicular fossa does not allow for a good visualization of the SVC walls.

It was recently demonstrated in a short pilot study that TTE examination of the SVC flow with a micro-convex ultrasound transducer (GE 8C-RS) seems both easy to learn and to use (feasibility = 84.9%), and is reproducible in most ventilated ICU patients with an intraclass correlation coefficient for the systolic fraction of the superior vena cava flow of 0.90 (95% confidence interval [0.86-0.93]).

The hypothesis is that cardio-respiratory interactions in intubated-ventilated patients are responsible of SVC flow variations and that the analysis of the SVC flow respiratory variations could be a new predictive tool of fluid responsiveness.

location_facility: Département d'Anesthésie-Réanimation, Hôpital Edouard Herriot,


title: Comparative Study on Acute Pain Evaluation Between Spanish and French Hospital Emergency Unit

acronym: DASAU

summary:
Today, pain is a difficult affordable subject in Spain. There are however 187 units of pain care with a consultations rate in emergency center of more than 60%.For example OXYCODONE(opioid analgesic)is widely used while it's under used in Spain.

In the same way MEOPA(Kalinox) is a new approach of pain care daily used as well in France (for example in dislocated shoulder pain, or ulceration care...etc) There are lots of studies relative to chronic pain but not too much about acute pain in Spain.That's why we want to focus our study on evaluation of acute pain treatment and efficacy in french and spanish hospital


title: Impact of an Intensive Care Diary on Post-traumatic Stress Disorder on Patients After a Resuscitated Sudden Death and His Relatives

acronym: COREABOR

summary:
Sudden death is a public health problem with more than 300,000 cases per year in USA and 40,000 cases per year in France. Moreover, despite all recent therapeutic improvements (therapeutic hypothermia, new techniques of resuscitation…), the prognosis remains drastically poor and less than 50% of the patients admitted alive at hospital will survive to the event at 1 year.

Outside all medications and technical care to improve patient prognosis, a psychological evaluation looks also critical to detect the occurrence of a "post traumatic stress syndrome". In fact, along with the event severity, a variable period of amnesia related to coma may favor the occurrence of such a syndrome and psychological issues, which at the end may lead to impairment of patient quality of life.

Previous studies have evaluated the impact of an intensive care unit diary on psychological distress in patients and relatives in the context of severe traumatisms. Such an evaluation has however never been done in the specific setting of sudden death and the frequency of this syndrome is unknown in this context.

Aim The aim of the present study is to evaluate the impact of an intensive care unit diary on the occurrence of a "post traumatic stress syndrome" after a sudden death.

Secondary objectives

To evaluate the frequency of the occurrence of a "post traumatic stress syndrome" and other psycho traumatic symptoms after sudden death
To evaluate the impact of an intensive care unit diary on the severity of this syndrome, psycho traumatic symptoms, and psychopathologic comorbidities
To evaluate the impact of the diary on psycho traumatic symptoms and their severity in patient's relatives
To evaluate the satisfaction of the patients and their relatives regarding medical cares in both groups (with and without diary)
Comparison of nurse diagnostic (psychological distress) and diagnostic made by dedicated personal with a specific formation in psychology
Qualitative evaluation of the diary
Evaluation of the paramedical feeling before and after the diary input in practice

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Lille


title: Teaching General Practitioners to Use the Patient-centered Approach When Suggesting Colorectal Cancer Screening

acronym: FORCEPS

summary:
Context : Colorectal cancer (CRC) mass screening has been implemented in France since 2008. Participation rates remain too low. The objective of this study is to test if the implementation of a training course focused on communication skills (whether in-person or e-learning) among general practitioners (GP) would increase the delivery of gFOBT and CRC screening participation among the target population of each participating GP.

Method : Pragmatic controlled cluster randomized trial with 2 parallel groups: Control versus Educational Intervention Intervention ; six hour educational training either in person or through e-learning The Main objective: is to evaluate the effectiveness of an educational intervention teaching physicians the patient-centered approach, either in-person or through e-learning, by evaluating their patients' participation in colorectal cancer (CRC) screening for all risk categories.

lead_sponsor: Collège de la Médecine Générale, France


title: Development of a Classification of the Components of Patient Therapeutic Education Interventions That Can Impact Their Results and Can Ensure Their Continued Existence CONCErTo Study

acronym: CONCErTo

summary:
Interest in patient therapeutic education (PTE) is increasing: in France PTE was included within the 2009 "Hospital, Patient, Health and Territory" law as an essential component of the patient healthcare pathway.

PTE is a complex intervention: its delivery is variable and may vary according to its content, functioning, providers, targeted patients, environment and even its objectives. These differences impact the expected results and make difficult the evaluation of PTE interventions. To overcome this difficulty, it is essential to describe precisely the intervention, the processes and the implementation of PTE that are usually not known. PTE interventions need today a global understanding of their mechanisms constituting their complexity.

CONCErTo study aims at developing a classification of the different elements composing a PTE intervention that can impact their results and can ensure their continued existence.

Mechanisms implemented during PTE interventions will be analyzed by a qualitative research. The investigators wish to identify organizational, pedagogical, psychosocial, medical or contextual elements that can impact the results, the patients' participation and the continuity of the program.

The perspective of this research is to improve the understanding of PTE by providing thorough description of the interventions. This work will help stakeholders to better interpret the results of their interventions, to improve the transferability, the implementation and finally to determine which are the elements able to improve patients' health status.


title: Comparison of Follow-up by Mobile Application or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery: Monocentric, Prospective, Randomized Study

acronym: OFUE

summary: This study evaluate if in an outpatient rotator cuff surgery, can the use of mobile app compared to conventional paper questionnaire improve follow-up care in the first 90-days following surgery.

ReferenceCitation: Gil JA, Durand WM, Johnson JP, Goodman AD, Owens BD, Daniels AH. Unanticipated Admission Following Outpatient Rotator Cuff Repair: An Analysis of 18,061 Cases. Orthopedics. 2018 May 1;41(3):164-168. doi: 10.3928/01477447-20180501-04. Epub 2018 May 9.

ReferenceCitation: Calvo E, Torres MD, Morcillo D, Leal V. Rotator cuff repair is more painful than other arthroscopic shoulder procedures. Arch Orthop Trauma Surg. 2019 May;139(5):669-674. doi: 10.1007/s00402-018-3100-0. Epub 2018 Dec 17.

ReferenceCitation: Kosinski LR, Gil JA, Durand WM, DeFroda SF, Owens BD, Daniels AH. 30-Day readmission following outpatient rotator cuff repair: an analysis of 18,061 cases. Phys Sportsmed. 2018 Nov;46(4):466-470. doi: 10.1080/00913847.2018.1502571. Epub 2018 Jul 27.

ReferenceCitation: Higgins J, Semple J, Murnaghan L, Sharpe S, Theodoropoulos J. Mobile Web-Based Follow-up for Postoperative ACL Reconstruction: A Single-Center Experience. Orthop J Sports Med. 2017 Dec 22;5(12):2325967117745278. doi: 10.1177/2325967117745278. eCollection 2017 Dec.

ReferenceCitation: Armstrong KA, Coyte PC, Brown M, Beber B, Semple JL. Effect of Home Monitoring via Mobile App on the Number of In-Person Visits Following Ambulatory Surgery: A Randomized Clinical Trial. JAMA Surg. 2017 Jul 1;152(7):622-627. doi: 10.1001/jamasurg.2017.0111.

lead_sponsor: L'Institut de Recherche en Chirurgie Orthopédique et Sportive


title: Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in French Gastro and Hepatology Departments

acronym: OBADE

summary:
Baclofen is an agonist of the amino-butyricum B (GABA-B) receptor used for a long time in neurology to treat spastic contracture. Several clinical studies have suggested its efficacy in the treatment of alcohol-dependence in low, even in case of cirrhosis and high dose. French drug authority has authorized its use in 2012 whereas the l'European Association for the Study of the Liver recommends to perform additional studies on this indication.

The goal of this observational study is to evaluate the use of baclofen for alcohol-dependence in real life care as well its efficacy.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz


title: Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey

acronym: ATC

summary: The study focuses on the antibiotic prophylaxis use in adult heart transplantation in France.

time_perspective: Other

ReferenceCitation: Zuckermann A, Barten MJ. Surgical wound complications after heart transplantation. Transpl Int. 2011 Jul;24(7):627-36. doi: 10.1111/j.1432-2277.2011.01247.x. Epub 2011 Mar 21. Review.

ReferenceCitation: Montoya JG, Giraldo LF, Efron B, Stinson EB, Gamberg P, Hunt S, Giannetti N, Miller J, Remington JS. Infectious complications among 620 consecutive heart transplant patients at Stanford University Medical Center. Clin Infect Dis. 2001 Sep 1;33(5):629-40. Epub 2001 Aug 6. Review.

ReferenceCitation: Ramos A, Asensio A, Muñez E, Torre-Cisneros J, Blanes M, Carratalá J, Segovia J, Munoz P, Cisneros JM, Bou G, Aguado JM, Cervera C, Gurgui MM. Incisional surgical infection in heart transplantation. Transpl Infect Dis. 2008 Jul;10(4):298-302. doi: 10.1111/j.1399-3062.2008.00316.x. Epub 2008 May 15.

lead_sponsor: University Hospital, Caen


title: Impact of COVID19 Outbreak in Cardiac Patients Admitted in Intensive Care Unit : the CCU-COVID19 Study

summary: This registry will evaluate the impact of the COVID19 outbreak on Cardiac patients admitted in the Intensive Care Unit of the Pitie-Salpetriere Hospital in Paris, France

ipd_sharing: Yes

ipd_sharing_description: Open to collaboration

location_facility: Unité de Soins Intensifs de Cardiologie, Pitié Salpêtrière Hospital, AP-HP


title: Comparison of Regional Citrate Anticoagulation and Regional Anticoagulation by Citrate-Free Decalcification in Renal Replacement Therapy Using Sustained Low-Efficiency Dialysis

acronym: ARDC-SLED

summary: One of the main RRT issue is anticoagulation of the ECC, because blood contact with biomaterials causes bio-incompatibility reactions, including activation of coagulation cascade. Based on Regional Citrate Anticoagulation (RCA) protocoles, an ionized calcium (Caion) concentration around 0.25 to 0.35mmol / L prevents fibrinoformation and allows anticoagulation for the ECC. During RCA, metabolic side effects may occur due to systemic passage of citrate. Our postulate is that reduction of ionized calcemia related to the use of a calcium-free dialysate and haemofilter performance makes it possible to avoid citrate infusion. Our study aim to compare intermittent RRT using 4% Citrate infusion and without Citrate.

lead_sponsor: Groupe Hospitalier Sud Ile-de-France


title: Prevalence of Osteoporosis in Sickle Cell Disease

acronym: DREPAN'OS

summary:
Sickle cell disease is the most common single-gene disease in the world. Its prevalence is increasing in France, with patients' life expectancy increasing into developed countries. It mainly affects populations originating from sub-Saharan Africa. Among the chronic bone complications associated with sickle cell disease, osteoporosis has previously been highlighted but remains a poorly known complication in this very particular context. A dedicated evaluation of osteoporosis and associated risk factors in sickle cell disease patients living in France may enable better bone management of these patients in the future, as this problem, specific to their disease, is likely to become more frequent as their life expectancy increases.

This is a prospective interventional and monocentric study whose objective is to describe the prevalence of osteoporosis in black patients with sickle cell disease in France

lead_sponsor: Hospices Civils de Lyon


title: An Efficacy and Safety Study to Evaluate Ranger Drug-eluting Balloon for Below the Knee Angioplasty in Patients With Critical Limb Ischemia

acronym: RANGER-BTK

summary:
Endovascular treatment of below the knee disease is a well-established therapy to improve outcomes in patients with critical limb ischemia. Several large cohort studies demonstrated the safety and the efficacy of percutaneous recanalization and angioplasty for distal vessel disease. A successful recanalization of foot artery was related to a higher ulcer healing and a reduction of major amputation. Moreover absence of revascularization in a patient with critical limb ischemia is an independent risk factor for mortality. Despite the introduction of new devices dedicated to below the knee vessel disease treatment, with the development of guides and conical balloons, long term patency outcomes are still poor. Restenosis was observed in more than two thirds of patients within 3 months after angioplasty of tibial arteries with a high target lesions revascularization. These re-interventions are characterized by a higher morbidity and mortality due to several comorbidities associated to these patients. These data confirm the need to obtain more lasting results in order to improve long-term outcomes of these patients.

Recently, the use of drug-eluting balloons (DEB) has revealed an increase in patency after angioplasty of the femoral artery. On the contrary, results for BTK arteries angioplasty have shown controversial results.

The purpose of this study is to evaluate the safety and the efficacy of the Ranger™ SL paclitaxel coated balloon a model of drug eluting balloon in patients with critical limb ischemia.

location_facility: AP-HP - Hopital Europeen Georges-Pompidou Paris, France


title: Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients

summary:
The analysis of a cohort of consecutive non-selected patients from the Strasbourg University Hospital, and therefore representative of the real life, will allow better identifying the risk factors for these infections (by comparison with a cohort of patient with similar conditions of immunosuppression and no infection) and improving the diagnosis and therapeutic management.

The primary objective is to identify prognosis factors affecting survival in patients with opportunistic infections


title: Well-being and Stress Control After Colorectal Surgery

acronym: C-Cien

summary:
The criteria usually considered to evaluate the quality of life are the presence or absence of a stomy, alteration of the transit or the sexual dysfunctions. Quality of life has been improved by introducing an Enhanced Postoperative Rehabilitation Program After Surgery (ERAS). It is a multidisciplinary medical and paramedical care aimed at minimizing the sources of stress allowing a significant reduction in postoperative complications and length of stay.

However, the emotional feelings of patients, their fatigue, the quality of their relationships with others and their experience of the disease are not usually considered. Nevertheless, these criteria influence the quality of life and constitute the fundamental bases of the psychological well-being, essential in the recovery processes.

We propose to enrich the ERAS program by introducing an individualized support of well-being and stress management aimed at increasing the quality of life of patients. The purpose is to make the patient more autonomous by allowing him/her, to implement stress management exercises.

The main goal of the project is to improve the psychological well-being of patients operated on for colorectal cancer by offering stress management sessions in order to promote postoperative rehabilitation.

The secondary objectives are to demonstrate the impact of stress management sessions on the length of stay and to study the link between the efficiency of these sessions and the quality of life of patients before the surgery.

intervention_type: Behavioral


title: Study of the Photomotor Reflex to Evaluate the Role of the Non-visual Effects of Light in Neurological, Psychiatric and Ophthalmological Pathologies

summary: The light has visual and non-visual effects on organism and can act on the behavior, the mood, the cognition and the sleep. These effects are mediated by "classical" retina photoreceptors which allow vision (rods, cones) but also melanopsin cells. The non-visual effects of light seems to be altered in many neurological, psychiatric or ophtalmological conditions but their exact role in the pathogenesis remains poorly understand. The purpose of the study is to increase our knowledge of the non-visual effects of light and establish new therapeutic applications


title: Pain Evaluation After Treatment of Extra-spinal Bone Metastases With OsteoCOOL Radiofrequency (RF) Ablation System

acronym: PERFACOOL

summary: To evaluate the worst pain of cancer patients with painful extra-spinal bone metastases 1 month after bipolar radiofrequency ablation (RFA) performed with the Osteocool system.

primary_purpose: Prevention


title: Kinectics of Distribution of Doxorubicin-Lipiodol Emulsion in c-TACE: a Pilot Study

acronym: CineDoxo

summary:
Conventional transarterial chemoembolization with Doxorubicin (c-TACE) is the gold standard treatment for Hepato Cellular Carcinoma (HCC) stage B (BCLC) / stages A and B (Child-Pugh). Clinical recommendations for cTACE indicate that the doxorubicin solution may be reconstituted in either aqueous solution or iso-osmolar ionic iodinated contrast media. There is no consensus on which solvent should be used. Hence, the clinical evaluation of Lipiodol cTACE would benefit from a standardization in the reconstitution of the drug. In this study, the comparison of the kinetics of distribution of the drug within the tumor micro-environment is expected to allow for comparison of drug solvents.

This pilot study aims at evaluating the kinetics of distribution of the drug within the tumor micro-environment, for the two main solvents used in reconstituting the drug, namely normal saline and contrast media. The kinetics of distribution in the tumor will be evaluated primarily through regular biopsy sampling, and secondary with confocal laser endomicroscopy.


title: Prospective, Randomised, Placebo-controlled Study of Polyvalent Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies

acronym: TINISS

summary:
To summarise, the peripheral neurological complications experienced by patients with primary Sjögren's syndrome are particularly bothersome since they are common and often result in significant disability related to pain or motor impairment. There is currently no standard treatment for these patients.

As these neuropathies are caused by an immune system dysfunction, which is related to a variety of different pathogenic mechanisms, the use of immunosuppressant or immunomodulator drugs is often justified.

With the exception of the vascularitis-related multiplex mononeuropathies, other pSS-related neuropathies could be suitable candidates for IV Ig treatment.


title: Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis

acronym: TREXO

summary: Ocular toxoplasmosis (OT) is a major cause of visual impairment worldwide. OT is responsible for 30 to 50% of posterior uveitis. It is characterized by dormant infections that may reactivate without known reasons, causing severe irreversible visual loss. The overall recurrence rate of OT in Europe is greater than 80% for patients and may range from one episode to 11 episodes (1% of OT) in the most extreme cases. Current treatments do not reduce the risk of recurrences and the risk of toxoplasmosis recurrence cannot be predicted in these immunocompetent patients. These clinical and biological expression changes might be related to an individual genetic susceptibility of each patient. The advanced analysis of the entire genome now possible to consider the project.

status: Terminated

intervention_type: Biological


title: Prospective Evaluation of a New Approach to Perform an Esophageal Myotomy: the Transesophageal Submucosa Approach

summary:
Achalasia is an esophagus motor disability characterized by a lack of relaxation of the lower esophageal sphincter (LES) to deglutition. Myotomy is the gold standard surgical technique allowing to cure this pathology. In this study, investigators are using a new endoluminal technique of myotomy, innovative and less invasive, called POEM (PerOral Endoscopic Myotomy). This technique does not require any cutaneous incision.

Mini-invasive surgery is more and more associated to endoscopy. The practice was initiated by the accession of natural orifice transluminal endoscopic surgery (NOTES). In this context, the introduction of the POEM technique seems to be an original approach and a natural evolution to a new generation of surgical endoscopy.


title: Biomoleculars Markers of Sensitivity to Pre- and Post-operative Chemotherapy of Gastric and Cardia Adenocarcinomas: a Pilot Study

summary:
Some subtypes of gastric and cardia tumors such as adenocarcinoma or gastric linitis with disseminated cells respond poorly to the pre-operative chemotherapy, and some of them do not respond to chemotherapy usually performed. Doing chemotherapy in these patients could delay their surgical management. The completion of chemotherapy for these patients would be a bad prognosis factor according to recent data from the literature. Therefore, the aim of this research is to find prognostic markers of sensitivity to chemotherapy usually performed. The investigators are going to use biopsies realized at diagnosis and select patients "good and bad" responders.

Primary purpose:

To study cardia and gastric tumors, molecular markers sensitivity to pre- and post- perative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation

Secondary purposes:

To assess the impact of patients' lifestyle (via a questionnaire) on the response to chemotherapy
To study markers of cancer stem cells
To correlate clinical and molecular markers with patient survival and quality of life questionnaires
To characterize the expression levels (Met, Her2, FGFR2) and mutations (p53 ras) in frequently deregulated genes in gastric cancers.
To characterize the level of expression of predictive candidate markers (ΔNp73, TAp73, HDAC4, mir140, EZH2, CXCL12, CXCR4, CXCR7) found in the literature.
To correlate the abnormalities found in the with tumor stages (before and after chemotherapy) and with 5 years overall survival and progression-free patients


title: Life Quality Determinant Assessment of Fibromyalgia Patients Related to Health Devices

acronym: FIBROQUALLIFE

summary: The primary purpose is the evaluation of life quality of Fibromyalgia patients. The investigators' main hypothesis includes the role of geographical, sociological, psychological and physical activity on life quality.


title: Morcellator Versus Resectoscope in the Treatment of Uterine Polyps by Hysteroscopy

acronym: RESMO

summary:
Intrauterine pathologies are currently treated by hysteroscopic resection. In this surgical procedure, the intrauterine pathology is resected by a transcervical approach in several fragments using a mono or bipolar cove after distension of the uterine cavity and by endoscopic control. The main risks of this surgery are: uterine perforation and OHIA (operative hysteroscopy intravascular absorption) syndrome. Hysteroscopic morcellators are new intrauterine devices, recently appeared on the French market.

In comparison to classical resectors, morcellators have several theoretical advantages:

A smaller instrument diameter with potentially a lower risk of uterine perforation and cervical laceration during the dilatation procedure,
The use of physiological serum, eliminating the risk of neurological toxicity of glycine,
The risk of electrical accident is canceled (internal or external burns due to leakage current),
A decreased risk of air embolism, due to the absence of bubbles' production,
The instrument is always under visual control, the perforation risk by the active instrument is therefore very limited,
The vision is not obscured by the fragments or by the bubbles,
The treatment of pre-ostial pathologies, not always easy in classical resections, could be facilitated,
the absence of thermal effect, and therefore a potentially lower endometrial aggression, is interesting in women with reproductive desire,
Absence of chips management, limiting the entry and exit movements in the uterine cavity, improving the vision, reducing the infectious and traumatic risks, specially uterine perforation and air embolism,
Morcellation could preserve tissues for histological analysis of possible malignancy (compared to techniques using heat, coagulation, vaporization),
Easy learning in comparison to the time-consuming learning of classical hysteroscopic resection,
Generated additional cost could be partly amortized by reducing operating time and complications.

It seemed useful to study this new technology.

The primary purpose was to compare the time of hysteroscopic treatment of uterine polyps between a hysteroscopic morcellator the UNIDRIVE S III / DrillCut-X II-GYN-Shaver (Integrated Bigatti Shaver IBS), Storz®, and a conventional resectoscope.

The secondary purposes were to compare the efficiency, complications and comfort of these techniques.


title: Evaluation of a Regional Post-discharge Monitoring System for Suicide Attempters in the North-Pas de Calais Region of France

acronym: VIGILANS

summary:
VigilanS is an innovative healthcare program. Participants of this program are all patients leaving in the Nord-Pas de Calais region who survived a suicide attempt.

General goals of the post hospitalization monitoring system for suicidal attempters are:

Standardize general healthcare's practices by offering alert networks and innovative response procedures in case of suicidal crisis.
Coordinate the various health partners' actions around the patient (GP, psychiatrist, psychologist).
Contribute to reducing mortality and morbidity by suicide (subsequent suicide) in determined territories.

The evaluation of VigilanS will be quantitative and qualitative.

ReferenceCitation: Fossi LD, Debien C, Demarty AL, Vaiva G, Messiah A. Suicide reattempt in a population-wide brief contact intervention to prevent suicide attempts: The VigilanS program, France. Eur Psychiatry. 2021 Jul 16;64(1):e57. doi: 10.1192/j.eurpsy.2021.2221.

family: Djembi Fossi

full_name: Larissa Djembi Fossi

given: Larissa

family: Debien

full_name: Christophe Debien

family: Demarty

full_name: Anne-Laure Demarty

given: Anne-Laure

family: Vaiva

full_name: Guillaume Vaiva

given: Guillaume

family: Messiah

full_name: Antoine Messiah

given: Antoine

currency_apc_doaj: EUR

journal_name: European Psychiatry

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_normalized: HAL

version: acceptedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repositories:
HAL
PubMed Central

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

publisher: Royal College of Psychiatrists

publisher_dissemination: Royal College of Psychiatrists

publisher_group: Royal College of Psychiatrists

publisher_normalized: Royal College of Psychiatrists

title: SUICIDE REATTEMPT IN A POPULATION-WIDE BRIEF CONTACT INTERVENTION TO PREVENT SUICIDE ATTEMPTS - THE VIGILANS PROGRAM, FRANCE

ReferenceCitation: Duhem S, Berrouiguet S, Debien C, Ducrocq F, Demarty AL, Messiah A, Courtet P, Jehel L, Thomas P, Deplanque D, Danel T, Walter M, Notredame CE, Vaiva G. Combining brief contact interventions (BCI) into a decision-making algorithm to reduce suicide reattempt: the VigilanS study protocol. BMJ Open. 2018 Oct 23;8(10):e022762. doi: 10.1136/bmjopen-2018-022762.

apc_source: openAPC

family: Duhem

full_name: Stéphane Duhem

given: Stéphane

family: Berrouiguet

full_name: Sofian Berrouiguet

given: Sofian

family: Ducrocq

full_name: François Ducrocq

given: François

full_name: Anne Laure Demarty

given: Anne Laure

family: Courtet

full_name: Philippe Courtet

given: Philippe

family: Jehel

full_name: Louis Jehel

given: Louis

family: Thomas

full_name: Pierre Thomas

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - TEL - Thèses en ligne

location_facility:
General Hospital, Cambrai
General Hospital, Armentieres
General Hospital, Seclin
St Vincent's Hospital, Lille
General Hospital, Lens
General Hospital, Denain
General Hospital, Hazebrouck
General Hospital, Fourmies
General Hospital, St Omer
Riaumont's Polyclinic, Liévin
Genral Hospital, Maubeuge
General Hospital, Montreuil sur Mer
General Hospital, Bethune
General Hospital, Valenciennes
General Hospital, Dunkerque
General Hospital, Boulogne sur Mer
General Hospital, Douai
General Hospital, Roubaix
University Hospital, Lille
EPSM, St Venant
General Hospital, Calais
St Philibert's Hospital, Lomme
Polyclinic, Henin-Beaumont
Clinic Fleury, Hénin Beaumont
General Hospital, Tourcoing
General Hospital, Arras
EPSM, Tourcoing
Lucien Bonnafé Hospital, Roubaix


title: Epidemiological Profile of Children With Early Caries: a Study in the Hauts-de-France Region

acronym: EPIECC

summary: The objective of the study is to determine the different profiles of patients with early caries consulting at the Lille CHU and to analyse the characteristics associated with the severity of the pathology. The data will be collected using a simple clinical examination of the child and a survey of the parent using a questionnaire. The typology of patients with early caries will be analysed according to the predefined variables collected using the questionnaire via a main component analysis in order to study the links between these variables. At the same time, a hierarchical classification analysis will be carried out to study the existence of homogeneous sub-groups of individuals in regard to the early caries. These sub-groups will be described