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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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

location_facility: Centre Hospitalier Universaitaire Hôpital mère-enfant

location_facility: GCS Hôpitaux pédiatriques Centre Hospitalier Universitaire Lenval

location_facility: Institut d'Hématologie et Oncologie Pédiatrique

location_facility: Centre Hospitalier Universitaire Hôpital Nord

location_facility: Centre Hospitalier Universaitaire hôpital d'enfants

location_facility: Centre Hospitalier Régional Universitaire Hôpital Saint-Jacques

location_facility: Centre Hospitalier Universitaire Hôpital Sud

location_facility: Centre Hospitalier Universaitaire Hôpital Côte de Nacre

location_facility: Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche

location_facility: Centre René Gauducheau de Nantes Atlantique

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

location_facility: Centre Hospitalier Universitaire Hôpial Hôtel Dieu

location_facility: Centre Hospital-Universitaire Hôpital Nord


type: Other Identifier

title: A retrospecTive and Prospective Non-Interventional Study to Assess the Clinical pracTice in Real Life for Patients With Wet AMD Refractory to raNibizumab and Switching to Aflibercept

acronym: TITAN

summary:
The aim of the TITAN study is to describe the clinical practices of a cohort of patients with wAMD refractory to ranibizumab (persistence of intra-retinal and/or subretinal fluid) who switch to aflibercept after less than 12 months of ranibizumab treatment.

The study will be conducted in real-life conditions and will allow describing conditions of use of aflibercept in patients refractory to ranibizumab

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Other

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Razavi S, Kodjikian L, Giocanti-Aurégan A, Dufour I, Souied E. Efficacy and safety of intravitreal aflibercept in ranibizumab-refractory patients with neovascular age-related macular degeneration. BMC Ophthalmol. 2021 Feb 17;21(1):90. doi: 10.1186/s12886-021-01841-6.

lead_sponsor: Bayer

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Neurodevelopmental Assessment and Parents Feelings at 7-8 Years of Age for Prematurely Born Children Involved in the Réseau Périnatal Lorrain Follow-up Program

summary:
Thanks to the evolution in knowledge and technical advances in premature newborn intensive care, the survival of very premature infants is now possible. However, prognosis remain sometimes uncertain.

In 2011, the Epipage 2 study showed a significant improvement as compared with the 1997 Epipage1 study with a decrease in mortality and an increase of the survival rate without severe morbidity of 14% for preterm babies born between 25 and 29 weeks and 6% for babies born between 30 and 31 weeks.

However, surviving babies without initial major deficiencies, may later show problems in terms of growth, sensory - motor and/or neuro-psychologic development. This untoward evolution lead to social and family interaction disorders and school difficulties.

In this context, a perinatal care network was created for each Region in France, making it possible to take care of these vulnerable children early on and all along their development. A retrospective study will evaluate 97 pre-term babies born before 33 weeks in 2012 and who are taken care of at Nancy as part of the Lorraine regional network program "Rafael" until they are 7 years old.

The objective is to evaluate objectively the neurocognitive and school abilities of these children at the age of 7.

At 8 years of age, a secondary measure of outcome will be the impact of the eventual neurocognitive consequences on the quality of their family life, on the behavior of the child and the parents' feelings. This way more options to improve the way they are taken care of will be available.

time_perspective: Retrospective

lead_sponsor: Central Hospital, Nancy, France

lead_sponsor_type: academique


title: Collaborative Mental Health Care Model: an Evaluation of the Implementation of a Pilot in Four Health Homes

acronym: Mosaique

summary:
Frequent mental disorders (anxiety or mood disorders), an important part of primary care patient care, remain insufficiently detected and treated. Improving their care requires better coordination between general practice and specialized care. The collaborative care model developed in Washington State with the introduction of a care manager is recognized. About 100 randomized controlled trials have established its effectiveness and efficiency, in terms of improving the progression of disorders (remission rate), adherence, quality of life, professional and patient satisfaction, and cost savings. However, the possibility of implementation of these validated care remains to be explored. A dozen collaborative care implementation studies exist, all conducted in the USA and not having considered all the dimensions of the indicators of penetration, acceptability/adoption, feasibility, fidelity and cost. A first implementation in France is implemented since September 2021 in the Yvelines department on four sites of different size, organization and environments: the multi-professional health centers (MSP) of Mureaux and Celle St Cloud, the Chevreuse medical house and MG in isolated practice in Versailles.

The main objective of the research project is to evaluate the first implementation in France of collaborative care for frequent psychic disorders according to the indicators of penetration, acceptability/adoption, fidelity, relevance, feasibility and cost.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Health Services Research

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Dr Nadia YOUNES

location_facility:
Cabinet Médical Versailles
cabinet médical Versailles
Maison de Santé Pluridisciplinaire

intervention_type: Other

status_simplified: Ongoing


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.

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.

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.

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.

lead_sponsor: Institut de Myologie, France


title: Evaluation of the Future of Adolescents and Young Adults Received in an Early Care System

acronym: ReFSEF

summary:
This is a prospective clinical epidemiology study based on the naturalistic follow-up of a cohort of 1 500 young people aged 11 to 25 presenting consecutively over the course of one year at the Relais d'Ile de France.

Young people will be assessed on entry into the system (T0), at the end of the follow-up (T1) and 6 months after the end of the follow-up (T6).

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Fondation Santé des Étudiants de France

location_facility:
Relais 77
Relais - Centre Adour
Relais 93 - Sceaux


title: Acceptability of Human Papillomavirus Self-sampling in Women Living With HIV

acronym: AUTOCol

summary: Women living with HIV are unsufficiently screened for cervix cancer although they have a higher risk of developping it, resulting of many obstacles. Offering a new screening technique, more accessible and which doesn't require gynecologic examination, could help improving this coverage rate. HPV screening have a higher-performance for cervix cancer than smear test. Self-collected vaginal swabs are as efficient as vaginal swabs collected by clinicians. They are also proved acceptable among general population but only one study in South Africa is about women living with HIV. The main hypothesis is that self-collected vaginal swabs are also acceptable among women living with HIV in the CoreVIH IDF Nord cohort.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Prevention

lead_sponsor: Assistance Publique - Hôpitaux de Paris


acronym: PUFPAE

summary:
The purposes of this study are :

To know and to understand frequency and variability (quantitative and qualitative) of end-of-life emergencies in nursing homes.
To know and to understand practices applied in these situations depending on the institution and the different reasons of hospital use.
To know and to understand the practical and organizational elements, in nursing homes, that can determine a (re) hospitalization or an end-of-life

lead_sponsor: Rennes University Hospital


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 110 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.

ReferenceCitation: Dap M, Chen B, Banasiak C, Hossu G, Morel O, Beaumont M, Bertholdt C. Magnetic Resonance Imaging Angiography of Physiological and Pathological Pregnancy Placentas Ex Vivo: Protocol for a Prospective Pilot Study. JMIR Res Protoc. 2022 Aug 10;11(8):e35051. doi: 10.2196/35051.

location_facility: Centre Hospitalier Régional Universitaire de Nancy


title: Positioning, Utilization and Effectiveness of Osimertinib in First Line in Real-life Therapeutic Strategy in France Prospective Cohort of Locally Advanced and Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations

acronym: POSITHES

summary:
This is an observational multicenter study. A cross-sectional descriptive study of patients with locally advanced or metastatic Non Small Cell Lung Cancer with activating EGFR mutation treated by any first line therapy will be used to identify cohort with a prospective follow-up of patients initiating a treatment by osimertinib in first line

A cross-sectional descriptive study of all patients with locally advanced or metastatic NSCLC with activating EGFR mutation treated by any first line therapy will be collected at the study participating sites. The study which is transversal will allow to characterize the population of patients with locally advanced or metastatic NSCLC with activating EGFR mutation treated in first line, the day of first line initiation.
Additionally, a prospective study targeting a cohort of patients focusing on patients with locally advanced or metastatic NSCLC with activating EGFR mutation initiating a treatment by osimertinib in first line will be conducted to address describe in real life conditions the 36-months overall survival, patients baseline characteristics, disease evolution, sequencing and treatment patterns, and quality of life.

lead_sponsor: AstraZeneca


title: Etude 3000 ARTHROSES Symptomatic Knee and Hip Osteoarthritis Prevalence Survey. Programme de Recherche du Groupe Qualité de Vie, de la Section Epidémiologie et de la Section Arthrose de la Société Française de Rhumatologie

summary: Nationwide descriptive epidemiology survey aiming to determine lower limb OA prevalence, based on a validated method previously used to assess inflammatory rheumatism (rheumatoid arthritis and spondylarthropathy) prevalence in France.

time_perspective: Cross-Sectional

ReferenceCitation: Guillemin F, Rat AC, Mazieres B, Pouchot J, Fautrel B, Euller-Ziegler L, Fardellone P, Morvan J, Roux CH, Verrouil E, Saraux A, Coste J; 3000 Osteoarthritis group. Prevalence of symptomatic hip and knee osteoarthritis: a two-phase population-based survey. Osteoarthritis Cartilage. 2011 Nov;19(11):1314-22. doi: 10.1016/j.joca.2011.08.004. Epub 2011 Aug 16.

location_facility: Service de Rhumatologie. Hôpital de la Pitié-Salpêtrière

location_facility: Service de Rhumatologie. CHU de la Cavale Blanche

location_facility: Centre d'Epidémiologie Clinique. Service de rhumatologie. CHU Nancy

location_facility: Service de Rhumatologie. Hôpital Rangueil


title: Retrospective Clinical Study of Malaria in Strasbourg University

acronym: ACMUS

summary: The primary purpose is to describe the anamnestic, clinical, biological, and therapeutic characteristics of imported malaria in people originated from endemic areas. Indeed, clinicians have observed that people from such areas start malaria just after their arrival in France. Such observation needed to be confirmed. In addition, The investigators observed a variation in the laboratory diagnostic performance of malaria between hospital and private laboratories. Such observation also needed to be analyzed objectively

status: Unknown status

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de Maladies Infectieuses et Tropicales

status_simplified: Unknown


title: Etude de la Performance Diagnostique de l'EEG-Haute Résolution Sur la Localisation de la Zone épileptogène Pour le Traitement Chirurgical Des épilepsies Partielles Pharmaco-résistantes

acronym: EEG-HR

summary: Multicenter prospective study comparing the diagnosis value of high-resolution EEG and depth-EEG to localize the epileptogenic zone in drug resistant partial epilepsies.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceType: background

ReferenceCitation: Maillard L, Koessler L, Colnat-Coulbois S, Vignal JP, Louis-Dorr V, Marie PY, Vespignani H. Combined SEEG and source localisation study of temporal lobe schizencephaly and polymicrogyria. Clin Neurophysiol. 2009 Sep;120(9):1628-36. doi: 10.1016/j.clinph.2009.06.022. Epub 2009 Jul 24.

ReferenceCitation: Koessler L, Benar C, Maillard L, Badier JM, Vignal JP, Bartolomei F, Chauvel P, Gavaret M. Source localization of ictal epileptic activity investigated by high resolution EEG and validated by SEEG. Neuroimage. 2010 Jun;51(2):642-53. doi: 10.1016/j.neuroimage.2010.02.067. Epub 2010 Mar 4.

ReferenceType: result

ReferenceCitation: Koessler L, Cecchin T, Caspary O, Benhadid A, Vespignani H, Maillard L. EEG-MRI co-registration and sensor labeling using a 3D laser scanner. Ann Biomed Eng. 2011 Mar;39(3):983-95. doi: 10.1007/s10439-010-0230-0. Epub 2010 Dec 8.

ReferenceCitation: Koessler L, Salido-Ruiz R, Ranta R, Louis-Dorr V, Gavaret M, Maillard L. Influence of source separation and montage on ictal source localization. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:2898-901. doi: 10.1109/IEMBS.2010.5626321.

location_facility:
University Hospital of Marseille
Central Hospital

intervention_type: Device


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
Caen University Hospital
Rouen University Hospital

intervention_type: Procedure


title: Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study

acronym: DSNATUR

summary: Repetitive Transcranial Magnetic Stimulation (rTMS) for repetitive Transcranial Magnetic Stimulation) is a a recent technique to stimulate the brain in a way that non-invasive, for therapeutic purposes. The first trials of analgesic use of rTMS date back to about 15 years ago. years and clinical use has now entered the practice of some specialized centers. Used at a frequency less than or equal to 1 Hertz (Hz; a stimulation per second), it is called bass rTMS. frequency and results in inhibition of cortical excitability at the level of the stimulated area. Conversely, a stimulation with a frequency higher than 5 Hz, called high-frequency rTMS, will have an excitatory effect on the targeted neurons. In addition to its local effects at the stimulation site, rTMS can also have effects on distance on regions other than those directly targeted. The impact of this treatment would be the local modulation of the cerebral plasticity and also act on the anatomical connectivity and functional brain function in both healthy subjects and those who are patients with psychiatric disorders

primary_purpose: Treatment

lead_sponsor: Centre hospitalier de Ville-Evrard, France

location_facility:
Youcef Bencherif
Unité de recherche clinique


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: 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.

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


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.

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.

lead_sponsor: Saint-Louis Hospital, Paris, France


acronym: PRADO-IC

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.

Investigators goals are to make an inventory of PRADO-IC project in terms of its effectiveness on readmission of patients with heart failure.

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


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.


title: Impact of the COVID-19 Pandemic on Mental Health Service Utilization in Children and Adolescents

acronym: MENTALPED

summary: Mental health consequences of the COVID-19 pandemic may be vast and may potentially overwhelm the mental health system in a long-lasting manner. Evaluating the effects of the COVID-19 pandemic on mental health in vulnerable groups such as children and adolescents has become an immediate priority. The aim of this study is to evaluate the impact of COVID-19 pandemic on use of mental health resources namely 1) prescriptions of psychotropic medications and 2) mental health-related outpatient visits, hospitalizations and emergency department visits in children and adolescents in France. Secondary aim is to evaluate the impact of the pandemic on episodes of fatal and non-fatal self-harm episodes in the same population. This will be a population-based cohort study using data from healthcare claims, administrative medical and outpatient drug dispensation databases in France between January 1, 2016 and June 1, 2021. Findings will inform on the risk of upcoming outbreaks of mental disorders that can result in significant morbidity and mortality and guide timely targeted actions to improve mental health outcomes and wellbeing in the youngest.

location_facility: Robert Debre Hospital - Assistance Publique Hopitaux de Paris


title: Impact of Burden in Caregivers of Patients Hospitalized for a Psychotic Episode: a Multicenter Study

acronym: AFP

summary:
Family support is a positive predictor for psychiatric patients. For example, since the 1980s, it has been shown that family psychoeducation improves patient adherence to care and statistically decreases patient relapse and hospitalization rates by half, resulting in lower care costs. Yet, the stress of hospitalizing a patient, seeing the feelings of shame or guilt of caregiver and the impact on their quality of life are rarely taken into account by caregivers during the first weeks hospitalization in a patient's psychiatry.

Barrelet emphasizes the importance of organizing the meeting in the first hours of hospitalization with the family in order to strengthen the alliance, to improve communication.


title: Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study

acronym: TMS/DEP

summary:
number of center : 1

duration of study : 24 months
recruitement time : 23 months
Aim :Principal

Evaluate the interest of maintenance rTMS in a one-year double blind randomized controlled study for TRD patients.

Secondary

Evaluate the impact of rTMS on cognitive functions.

design_allocation: Randomized


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: Hôpital Bretonneau - Service des Maladies Infectieuses

location_facility: Service de Medecine Interne Hopital Antoine Beclere

location_facility: Service de Medecine Interne Hopital Cochin

location_facility: Hopital du Kremlin Bicêtre Service de médecine interne

location_facility: Service de Médecine interne - Centre Hospitalier Intercommunal


title: Pathologies métaboliques et Infectieuses en Population générale à La Réunion : étude REUNION

summary:
The aim of the present study is to determine the prevalence of cardiometabolic and infectious disease in La Reunion (french oversea department and region of France).

Known or suspected risk factor for these diseases will also be assessed, such as microbiota, cognitive impairement, social inequalities, and genetics.

location_facility: Centre Hospitalier Universitaire de La Réunion

intervention_type: Diagnostic Test


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.


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.

status: Active, not recruiting

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


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.

primary_purpose: Other

ReferenceCitation: Egnell M, Boutron I, Péneau S, Ducrot P, Touvier M, Galan P, Fezeu L, Porcher R, Ravaud P, Hercberg S, Kesse-Guyot E, Julia C. Impact of the Nutri-Score front-of-pack nutrition label on purchasing intentions of individuals with chronic diseases: results of a randomised trial. BMJ Open. 2022 Aug 29;12(8):e058139. doi: 10.1136/bmjopen-2021-058139.

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.

ReferenceCitation: Egnell M, Boutron I, Peneau 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.

lead_sponsor: University of Paris 13

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.

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 Working Group on the Evaluation of Carcinogenic Risks to Humans. Chemical agents and related occupations. IARC Monogr Eval Carcinog Risks Hum. 2012;100(Pt F):9-562. Review.

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.

ipd_sharing: Yes

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

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


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

lead_sponsor: Gérond'if


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.

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.

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: 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.

lead_sponsor: Hospices Civils de Lyon

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


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: 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: A Multicentre Prospective Longitudinal Observational Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies

acronym: ImmUniverse

summary:
UC is a chronic, idiopathic form of intestinal inflammatory disease (IBD) that affects the colon, most commonly afflicting adults aged 30-40 years and resulting in disability and lower quality of life (1). It is characterized by relapsing and remitting mucosal inflammation, starting in the rectum and extending to proximal segments of the colon. Although biologic therapies have provided clinical benefits to patients, these goals are still poorly met, due to the limited knowledge of the underlying mechanisms of immunopathology and the lack of predictive biomarkers that would allow proper patient stratification.

The hypothesis of this study is that by identifying new biomarkers in blood, stool and tissue that (i) predict response (or non-response) to therapy prior to the start of treatment and (ii) predict response to therapy in the early phase of treatment will allow to find the right treatment for the right patient (personalized medicine).

lead_sponsor: Central Hospital, Nancy, France


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: 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: 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.

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_description: Open to collaboration

lead_sponsor: Assistance Publique - Hôpitaux de Paris

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: 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: 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


type: EudraCT Number

title: Evaluation of Spironolactone Efficacy in Patient With Rheumatoid Arthritis (RA)

acronym: ALDORA

summary:
Evaluation of spironolactone, a well-known cardiological treatment, in patients with rheumatoid arthritis (RA).

The hypothesis is that spironolactone, through its anti-inflammatory and anti-fibrosis actions, decreases RA's activity. The primary objective is to assess the efficacy of spironolactone on RA activity by evaluating the proportion of patients achieving DAS28-CRP < 3.2 at 3 months (comparison between spironolactone and placebo arms). CRP (C reactive protein)

lead_sponsor: University Hospital, Strasbourg, France


title: Exploratory Metabolomics Study of Exhaled Breath in Pulmonary Embolism

acronym: MetabolAir

summary:
Pulmonary embolism is a frequent and recurrent pathology, especially in the elderly. It is often preventable, with high mortality and morbidity, making it a major public health issue. The clinical presentation of pulmonary embolism is non-specific and very highly variable, ranging from asymptomatic thrombus diagnosed incidentally to sudden death. The current diagnosis of pulmonary embolism is based on several diagnostic techniques, mainly non-invasive, which should be used sequentially.

We propose to sample the volatile organic compounds using a device that allows them to be trapped on polymer cartridges. Sampling will be performed under monitoring of respiratory pressure and a capnograph to collect alveolar and upper respiratory tract air separately without contamination of the oral cavity or sinuses.

This exploratory metabolic analysis will be non-targeted (analysis of all molecules detectable without a priori).

The main objective of the study is to identify specific metabolic profiles to predict the results of ventilation-perfusion pulmonary tomoscintigraphy in subjects undergoing this examination for suspected acute pulmonary embolism.

Secondary purposes :

To identify metabolic profiles to be used to predict, in combination with clinical probability scores, the results of ventilation-perfusion pulmonary tomoscintigraphy in subjects undergoing this examination for suspected acute pulmonary embolism.;
To correlate metabolic profiles with the topography of embolized lung territories


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-Bien

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.


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

primary_purpose: Basic Science

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 Nationale Des Enfants et Adultes Avec Syndromes d'Hypercroissance Dysharmonieuse National Evaluation of Patients With PIK3CA-Related Overgrowth Spectrum (PROS)

acronym: COSY

summary: Overgrowth syndromes are rare genetic disorders defined by tissue hypertrophy that can be either localized or generalized, affecting both latitudinal and longitudinal growth. The genes involved in overgrowth syndromes are not well characterized but mostly concern the PIK3CA/AKT/mTOR pathway, a major actor of cell growth and proliferation. The mutations are not inherited but occurs during embryogenesis leading to somatic mosaicism. Owing to the variability of the clinical presentation, their exact prevalence is yet unknown. In order to answer this question, the investigators team create here the first French national registry on overgrowth syndromes.

ReferenceCitation: Canaud G, Hammill AM, Adams D, Vikkula M, Keppler-Noreuil KM. A review of mechanisms of disease across PIK3CA-related disorders with vascular manifestations. Orphanet J Rare Dis. 2021 Jul 8;16(1):306. doi: 10.1186/s13023-021-01929-8. Review.

ReferenceCitation: Morin G, Canaud G. Treatment strategies for mosaic overgrowth syndromes of the PI3K-AKT-mTOR pathway. Br Med Bull. 2021 Dec 16;140(1):36-49. doi: 10.1093/bmb/ldab023. Review.

ReferenceCitation: Delestre F, Venot Q, Bayard C, Fraissenon A, Ladraa S, Hoguin C, Chapelle C, Yamaguchi J, Cassaca R, Zerbib L, Magassa S, Morin G, Asnafi V, Villarese P, Kaltenbach S, Fraitag S, Duong JP, Broissand C, Boccara O, Soupre V, Bonnotte B, Chopinet C, Mirault T, Legendre C, Guibaud L, Canaud G. Alpelisib administration reduced lymphatic malformations in a mouse model and in patients. Sci Transl Med. 2021 Oct 6;13(614):eabg0809. doi: 10.1126/scitranslmed.abg0809. Epub 2021 Oct 6.

ReferenceCitation: Morin G, Degrugillier-Chopinet C, Vincent M, Fraissenon A, Aubert H, Chapelle C, Hoguin C, Dubos F, Catteau B, Petit F, Mezel A, Domanski O, Herbreteau G, Alesandrini M, Boddaert N, Boutry N, Broissand C, Han TK, Branle F, Sarnacki S, Blanc T, Guibaud L, Canaud G. Treatment of two infants with PIK3CA-related overgrowth spectrum by alpelisib. J Exp Med. 2022 Mar 7;219(3). pii: e20212148. doi: 10.1084/jem.20212148. Epub 2022 Jan 26.

ReferenceCitation: Venot Q, Blanc T, Rabia SH, Berteloot L, Ladraa S, Duong JP, Blanc E, Johnson SC, Hoguin C, Boccara O, Sarnacki S, Boddaert N, Pannier S, Martinez F, Magassa S, Yamaguchi J, Knebelmann B, Merville P, Grenier N, Joly D, Cormier-Daire V, Michot C, Bole-Feysot C, Picard A, Soupre V, Lyonnet S, Sadoine J, Slimani L, Chaussain C, Laroche-Raynaud C, Guibaud L, Broissand C, Amiel J, Legendre C, Terzi F, Canaud G. Targeted therapy in patients with PIK3CA-related overgrowth syndrome. Nature. 2018 Jun;558(7711):540-546. doi: 10.1038/s41586-018-0217-9. Epub 2018 Jun 13. Erratum in: Nature. 2019 Apr;568(7752):E6.

ReferenceCitation: Manning BD, Toker A. AKT/PKB Signaling: Navigating the Network. Cell. 2017 Apr 20;169(3):381-405. doi: 10.1016/j.cell.2017.04.001. Review.

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

location_facility: Translational medicine and Targeted therapies unit, Hôpital Necker Enfants Malades