title: Prospective, Non-randomized, Open-label and Multi-center Study With the Establishment of a Clinical-biological Database.

acronym: DEPLR

summary:
Colorectal cancer (CRC): is one of the most frequent cancers, with almost 42152 new cases estimated in France for 2012. There are 3 levels of risk of developing CRC: moderate, high or very high. At each level of risk, appropriate follow-up recommendations are made. Immunological tests for fecal occult blood tests have emerged in recent years and have rapidly become established as benchmark tests in Europe and then in France (OC Sensor test) as part of mass screening. In the case of a positive immunological test, a diagnostic colonoscopy must be systematically organized in order to characterize the possible recto-colic cause of the digestive bleeding thus observed.

Measurement of the DNA present in the circulating blood (circulating DNA or cfDNA): allowed a significant advance in the personalized management of cancers, as a non-invasive test capable of producing diagnostic, prognostic, theranostic, and of therapeutic follow-up type.

The aim of the work is to measure the cfDNA concentration in subjects undergoing colonoscopy because of a positive immunological fecal test.

ReferenceCitation: Segnan N, Armaroli P, Bonelli L, Risio M, Sciallero S, Zappa M, Andreoni B, Arrigoni A, Bisanti L, Casella C, Crosta C, Falcini F, Ferrero F, Giacomin A, Giuliani O, Santarelli A, Visioli CB, Zanetti R, Atkin WS, Senore C; SCORE Working Group. Once-only sigmoidoscopy in colorectal cancer screening: follow-up findings of the Italian Randomized Controlled Trial--SCORE. J Natl Cancer Inst. 2011 Sep 7;103(17):1310-22. doi: 10.1093/jnci/djr284. Epub 2011 Aug 18. Erratum in: J Natl Cancer Inst. 2011 Dec 21;103(24):1903. Fracchia, M [added].

ReferenceCitation: Schoen RE, Pinsky PF, Weissfeld JL, Yokochi LA, Church T, Laiyemo AO, Bresalier R, Andriole GL, Buys SS, Crawford ED, Fouad MN, Isaacs C, Johnson CC, Reding DJ, O'Brien B, Carrick DM, Wright P, Riley TL, Purdue MP, Izmirlian G, Kramer BS, Miller AB, Gohagan JK, Prorok PC, Berg CD; PLCO Project Team. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. N Engl J Med. 2012 Jun 21;366(25):2345-57. doi: 10.1056/NEJMoa1114635. Epub 2012 May 21.

ReferenceCitation: Minozzi S, Armaroli P, Segnan N. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Principles of evidence assessment and methods for reaching recommendations. Endoscopy. 2012 Sep;44 Suppl 3:SE9-14. Epub 2012 Sep 25.

ReferenceCitation: US Preventive Services Task Force, Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, Epling JW Jr, García FAR, Gillman MW, Harper DM, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Owens DK, Phillips WR, Phipps MG, Pignone MP, Siu AL. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jun 21;315(23):2564-2575. doi: 10.1001/jama.2016.5989. Erratum in: JAMA. 2016 Aug 2;316(5):545. Erratum in: JAMA. 2017 Jun 6;317(21):2239.

ReferenceCitation: Mouliere F, El Messaoudi S, Pang D, Dritschilo A, Thierry AR. Multi-marker analysis of circulating cell-free DNA toward personalized medicine for colorectal cancer. Mol Oncol. 2014 Jul;8(5):927-41. doi: 10.1016/j.molonc.2014.02.005. Epub 2014 Mar 24.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: ICM - Institut régional du Cancer Montpellier


title: Clinical Pathways and Patients' Attitudes in Acute Low Back Pain

acronym: AcuteLBP

summary:
In France the prevalence of low back pain is 70 to 80 %. It's the leading cause of health expenditure in Europe and costs 900 million euros per year to health insurance in France. This is the second reason to consult a general practitioner. Acute low back pain is defined as low back pain lasts less than 6 weeks. It represents 60 to 70 % of low back pain but only 20% of the costs induced by low back pain in general. In fact, acute low back pain often heals spontaneously.

Risk factors for acute low back pain and risk factors for chronic low back pain have been the subject of many publications. They remain very difficult to prevent in practice because of their multiplicity. Preventing acute low back pain is part of the prevention of chronic low back pain. Patient care management of low back pain is well codified and consensual in the various international recommendations. However, their application is sometimes very disparate and bad habits on both patients and professionals persist. Advices recommended in the case of low back pain are widely disseminated but their applications are little studied. In 2017, in France, health insurance started a "back pain" prevention campaign with the objective of raising awareness of good attitudes in the event of back pain. It made an initial assessment of the different knowledges concerning spinal pain in the general population but also in the medical population with the aim of improving them. It appears that number of patients would not consult physician in this case. The many proposals of care and the diversity of medical professionals, paramedics and other stakeholders, proposing to cure low back pain form as many different clinical pathways. Use of alternative or unconventional medicines is poorly assessed. In this context, it seems relevant to evaluate patient clinical pathways and patients' attitudes.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

lead_sponsor: CHU de Reims

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Research of Infra Clinical Liver Injuries in Adult Patients Presented With Alpha-1 AT Deficiency

summary: This cohort study will evaluate the prevalence of the infra clinical liver injuries among a group of adult patients presenting with Alpha-1 AT deficiency followed up in a large university hospital in Lyon, France.

study_type: Interventional

primary_purpose: Screening

ReferenceType: result

ReferenceCitation: Guillaud O, Dumortier J, Traclet J, Restier L, Joly P, Chapuis-Cellier C, Lachaux A, Mornex JF. Assessment of liver fibrosis by transient elastography (Fibroscan(®)) in patients with A1AT deficiency. Clin Res Hepatol Gastroenterol. 2019 Feb;43(1):77-81. doi: 10.1016/j.clinre.2018.08.016. Epub 2019 Jan 3.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Femme Mère Enfant - Hospices Civils de Lyon


title: Barriers and Facilitators to Exercise for Individuals With Autoimmune Myasthenia Gravis, Congenital Myasthenic Syndrome or Lambert-Eaton Myasthenic Syndrome in France: a Descriptive, Cross-sectional Study

acronym: MYaEX

summary:
A few recent observational studies show that despite the lack of clear recommendations, many individuals with myasthenia participate in exercise. However, no link has been found between exercise and the severity of myasthenia symptoms, measured by the Muscle Myasthenia Score or the Myasthenia Gravis Composite Score. This suggests that there are other factors that may limit or prevent some individuals from being active, or factors which may facilitate participation in exercise.

Studies in other diseases have shown that there are internal (beliefs, motivation, etc.) and external (cost, accessibility, etc.) factors unrelated to the disease which may play a role in exercise participation.

The aim of this study is to identify factors that facilitate or limit exercise in individuals with autoimmune myasthenia gravis, congenital myasthenia syndrome and Lambert-Eaton syndrome.

time_perspective: Prospective

ipd_sharing: Undecided

lead_sponsor: Institut de Myologie, France

lead_sponsor_type: industriel


type: Other Identifier

title: Pre-Surgery Assessing HCV, HBV, HIV Status and Revealing During Consultation With Anesthesiologist

acronym: SAHARA

summary: The aim of the study is to assess the feasibility of HCV, HBV, HIV testing (according to the national guidelines) during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France. The feasibility will be the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus).

status: Terminated

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Procedure

status_simplified: Unknown


title: Sarcopenia in Axial and Peripheral Spondyloarthropathies

acronym: SASPAR

summary:
Spondylarthropathies (SpA) are among the most common chronic inflammatory rheumatisms in adults, responsible for a muscular loss or sarcopenia which can be very disabling, not much documented in the literature, and not yet studied in France. In addition, sarcopenia is associated with decreased physical activity and increased risk of falls and fractures. A better characterization of the determinants of this muscular loss will allow to better detect and take care of it.

The aim is to conduct the first French study on the prevalence and severity of sarcopenia in patients with spondyloarthropathies and to study the variables that may be associated with it. Finally, we propose to evaluate obesity related to sarcopenia in these patients and compare them to cases matched for age and sex (from OFELY / STRAMBO cohorts, Lyon, FRANCE).

This is a prospective interventional and monocentric study with minimal risks and constraints: patients will be included for one day for an evaluation of their sarcopenia by measuring their muscle strength, physical performance and body composition and recording of their socio-demographic and disease characteristics.

location_facility: Service de Rhumatologie - Hôpital Edouard Herriot

intervention_type: Radiation


title: Study of the Specific Seroprevalence of SARS-CoV-2 in a Sample of Patients and Salaried Staff From a French Anti-cancer Center at the End of the Containment Period of the SARS-CoV-2 Pandemic

acronym: canSEROcov

summary:
Since March 2020, France has been confronted with the SARS-COV-2 pandemic. Analysis of the data of its spread would indicate that close contact between individuals is necessary and containment would be the best way to contain this virus. France has therefore been contained since March 17, 2020 until 11 May 2020.

In order to assess the impact of the measures taken (containment) to protect patients and salaried staff of a french anti-cancer center on the spread of the virus, this observational study assesses the specific seroprevalence of SARS-COV-2 in all caregivers and non-carers of this hospital and in patients treated in consultation, day hospitalization, full hospitalization at the end of the containment period.

The objective for the staff cohort is to describe the seroprevalence and the link between the seroprevalence and sociological / demographic factors relating to the category of profession, to the contacts with the patients, to the presence in the hospital during the period of containment, to the conditions of home containment.

The objective for the patient cohort is to describe the seroprevalence and the link between the seroprevalence and factors relating to the type of cancer treated, the type of treatment and their possible modification during the period of containment, to the conditions of home containment.

lead_sponsor: Centre Georges Francois Leclerc

intervention_type: Biological


title: Study of the Neural Substrates of Alcohol Craving by High-resolution Electroencephalography

acronym: CRAVING-NET

summary:
Alcohol is the most consumed psychoactive substance in France and is responsible for 49,000 deaths per year in the country. Addictions, characterized by "the repeated impossibility of controlling a behavior and the continuation of this behavior despite the knowledge of its negative consequences", are a major public health issue in France and worldwide. Alcohol dependence (DSM-5 moderate to severe use disorder) is a chronic behavioral disorder, whose main characteristic is its high and prolonged risk of "relapse", i.e. the resumption of problematic consumption after a period of improvement (abstinence or reduction).

One of the main components of addiction is "craving", which can be defined as the irrepressible desire to use a substance (DSM-5, American Psychiatric Association). To date, despite functional imaging studies (fMRI), the brain mechanisms involved in craving remain poorly understood. In recent years, a new neuroimaging device has become available, both in research and in clinical settings: high-resolution electroencephalography (HRE). This non-invasive method allows to observe brain activity at the millisecond level.

The objective of the CRAVING-NET project is to better understand brain function in alcohol addiction, and in particular in craving.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

lead_sponsor: Rennes University Hospital

status_simplified: Ongoing


title: Iron Deficiency in Infants : Population-wide Study of the Protective Role of Toddler Milk Formula

acronym: CARMA

summary:
ID in children is the most frequent micronutrient deficiency in industrialized countries, including France. ID induces neurological impairment reducing cognitive, motor, and behavioral capacities in children in the short and long term.

The purpose of this study is to evaluate the principal determinants of ID in France in two-year-old children and to improve strategies for prevention and screening.

The main objective is to study the association between iron status in two-year-old infants living in France and the consumption of toddler milk formula after taking non-dairy iron ingestion, parental socioeconomic status and educational level into account.

The secondary objectives are the following :

to estimate the prevalence of ID and ID anemia in 2-year-old children living in France.
to improve clinical tools for ID screening. to improve strategies for laboratory screening.

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Baker RD, Greer FR; Committee on Nutrition American Academy of Pediatrics. Diagnosis and prevention of iron deficiency and iron-deficiency anemia in infants and young children (0-3 years of age). Pediatrics. 2010 Nov;126(5):1040-50. doi: 10.1542/peds.2010-2576. Epub 2010 Oct 5.

ReferenceCitation: Domellöf M, Braegger C, Campoy C, Colomb V, Decsi T, Fewtrell M, Hojsak I, Mihatsch W, Molgaard C, Shamir R, Turck D, van Goudoever J; ESPGHAN Committee on Nutrition. Iron requirements of infants and toddlers. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):119-29. doi: 10.1097/MPG.0000000000000206. Review.

ReferenceCitation: Ghisolfi J, Fantino M, Turck D, de Courcy GP, Vidailhet M. Nutrient intakes of children aged 1-2 years as a function of milk consumption, cows' milk or growing-up milk. Public Health Nutr. 2013 Mar;16(3):524-34. doi: 10.1017/S1368980012002893. Epub 2012 Jul 4.

ReferenceType: derived

ReferenceCitation: Guivarch C, Sacri AS, Levy C, Bocquet A, Lapidus N, Hercberg S, Hebel P, Chevé A, Copin C, Zouari M, Gouya L, de Montalembert M, Cohen JF, Chalumeau M. Clinical Prediction of Iron Deficiency at Age 2 Years: A National Cross-sectional Study in France. J Pediatr. 2021 Aug;235:212-219. doi: 10.1016/j.jpeds.2021.03.072. Epub 2021 Apr 6.

ReferenceCitation: Sacri AS, Bocquet A, de Montalembert M, Hercberg S, Gouya L, Blondel B, Ganon A, Hebel P, Vincelet C, Thollot F, Rallo M, Gembara P, Levy C, Chalumeau M. Young children formula consumption and iron deficiency at 24 months in the general population: A national-level study. Clin Nutr. 2021 Jan;40(1):166-173. doi: 10.1016/j.clnu.2020.04.041. Epub 2020 May 7.


title: Evaluation of Hypophosphatemia as a Predictive Marker of Mortality During Sepsis in ICU

acronym: PORPOISE-REA

summary: Retrospective study in the 3 intensive care units of the Brest Teaching Hospital (France) during a 18-months period (June 2014 -December 2015) to study the independent association between hypophosphatemia and 90-day mortality.

time_perspective: Retrospective

ReferenceCitation: Padelli M, Aubron C, Huet O, Héry-Arnaud G, Vermeersch V, Hoffmann C, Bettacchioli É, Maguet H, Carré JL, Leven C. Is hypophosphataemia an independent predictor of mortality in critically ill patients with bloodstream infection? A multicenter retrospective cohort study. Aust Crit Care. 2021 Jan;34(1):47-54. doi: 10.1016/j.aucc.2020.05.001. Epub 2020 Jul 27.

lead_sponsor: University Hospital, Brest


title: EVIDENS: Lung Cancer Patients Treated With Nivolumab: A Longitudinal, Prospective, Observational, Multicentric Study

acronym: EVIDENS

summary: This study will describe the characteristics of patients initiating nivolumab treatment for lung cancer and their outcomes over 3 years in France

ReferenceCitation: Barlesi F, Dixmier A, Debieuvre D, Raspaud C, Auliac JB, Benoit N, Bombaron P, Moro-Sibilot D, Audigier-Valette C, Asselain B, Egenod T, Rabeau A, Fayette J, Sanchez ML, Labourey JL, Westeel V, Lamoureux P, Cotte FE, Allan V, Daumont M, Dumanoir J, Reynaud D, Calvet CY, Ozan N, Pérol M. Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study. Oncoimmunology. 2020 Apr 12;9(1):1744898. doi: 10.1080/2162402X.2020.1744898.

lead_sponsor: Bristol-Myers Squibb


title: Evaluation of Hypophosphatemia as a Predictor of Sepsis in Surgical Resuscitation Units.

summary: Retrospective study in the surgical intensive care unit of the Brest Teaching Hospital (France) during a 6-months period (January 2015 -May 2015) to study the independent association between hypophosphatemia and 28-day infection.


title: Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents: a Randomized Controlled Trial

summary:
The incidence of type 1 diabetes is increasing in France. A recent cross sectional study has shown that in France, only 15% of children and 26% of adults had HbA1c<7%. Adolescents seem to need particularly a better metabolic control.

Working Hypothesis:

We hypothesized that a stricter control of glycaemia by nurse-counselling could probably improve metabolic control in adolescents with type 1 diabetes.

Objectives:

To show that nurse-counselling may improve levels of patient satisfaction.

Methodology:

The main criterion is the patient acceptance of diabetes measured by an analogical visual scale rated from 0 (I cope very well with my diabetes, I cope very badly with my diabetes) to 10 cm. The scale will be measured every quarter within 12 months follow-up. We wish to improve patient's appreciation by 10 mm, near to "I cope very well with my diabetes".

This is a randomised parallel group study with 36 subjects in each group. During the follow-up, the "routine follow-up" group will continue its routine care. The "complementary follow-up" group will be called by nurses every 15 days and consult monthly. HbA1c is the secondary criterion and will be measured every 3 months.

The total study duration is 18 months including 6 months for the recruitment and 12 months for the patients follow-up

design_allocation: Randomized

ReferenceCitation: Kassai B, Rabilloud M, Bernoux D, Michal C, Riche B, Ginhoux T, Laudy V, Terral D, Didier-Wright C, Maire V, Dumont C, Cottancin G, Plasse M, Jeannoel GP, Khoury J, Bony C, Lièvre M, Drai J, Nicolino M. Management of adolescents with very poorly controlled type 1 diabetes by nurses: a parallel group randomized controlled trial. Trials. 2015 Sep 8;16:399. doi: 10.1186/s13063-015-0923-7.

intervention_type: Behavioral


acronym: CHIRPAN

summary: This data base has been set in order to gather medical and surgical information from patients who have undergone surgery for pancreatic cancer, at Institut Paoli Calmettes or Assistance Publique des Hôpitaux de Marseille, France.

status: Recruiting

lead_sponsor: Institut Paoli-Calmettes


title: Impact of COVID-19 Infection in Patients With Hepatocellular Carcinoma: An Ambispective Study Nestled in the CHIEF Cohort

summary: Since December 2019, a new disease named COVID-19 linked to a new coronavirus, SARS-CoV2 has emerged in China in the city of Wuhan, Hubei province, spreading very quickly to all 5 continents, and responsible for a pandemic. France is the third most affected country in Europe after Italy and Spain. Groups of patients at a higher risk of developing a severe form of COVID-19 have been defined: this include patients with immunosuppressive disease as cancer or patients with advanced cirrhosis of the liver. Coronavirus liver injury had been described with SARS-CoV 1 and MERS-CoV. There is no data on liver damage associated with COVID-19 infection for compensated or decompensated cirrhotic patients. The objectives of this project are to estimate the incidence of COVID-19 in hepatocellular carcinoma population, both hospital and ambulatory, and to study the impact on the frequency of severe forms, the prognosis, but also liver function, and the management of hepatocellular carcinoma, in this context of pandemic

status: Unknown status

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Diagnostic Test


status: Active, not recruiting

primary_purpose: Treatment

acronym: AcSé

intervention_type: Drug

title: AcSé CRIZOTINIB : Secured Access to Crizotinib for Patients With Tumors Harboring a Genomic Alteration on One of the Biological Targets of the Drug.

lead_sponsor: UNICANCER

type: EudraCT Number

source: euctr

ReferenceCitation: Aparicio T, Cozic N, de la Fouchardière C, Meriaux E, Plaza J, Mineur L, Guimbaud R, Samalin E, Mary F, Lecomte T, Gomez-Roca C, Haineaux PA, Gratet A, Selves J, Menu Y, Colignon N, Johnson L, Legrand F, Vassal G. The Activity of Crizotinib in Chemo-Refractory MET-Amplified Esophageal and Gastric Adenocarcinomas: Results from the AcSé-Crizotinib Program. Target Oncol. 2021 May;16(3):381-388. doi: 10.1007/s11523-021-00811-8. Epub 2021 Apr 13.

ReferenceCitation: Moro-Sibilot D, Cozic N, Pérol M, Mazières J, Otto J, Souquet PJ, Bahleda R, Wislez M, Zalcman G, Guibert SD, Barlési F, Mennecier B, Monnet I, Sabatier R, Bota S, Dubos C, Verriele V, Haddad V, Ferretti G, Cortot A, De Fraipont F, Jimenez M, Hoog-Labouret N, Vassal G. Crizotinib in c-MET- or ROS1-positive NSCLC: results of the AcSé phase II trial. Ann Oncol. 2019 Dec 1;30(12):1985-1991. doi: 10.1093/annonc/mdz407.

summary:
This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy and the safety of the targeted agent crizotinib as a monotherapy in 23 cohorts of patients with identified activating molecular alterations in the crizotinib target genes. A cohort is defined by a pathology and a crizotinib-target alteration (eg gastric cancer with MET amplification).

For each cohort a two-stage design will be implemented. In the situation where expected accrual allows for a sufficient number of patients to be accrued, the alpha and beta errors will be fixed at 10%. However, in very rare diseases, such as inflammatory myofibroblastic tumor (IMT), neuroblastoma, glioblastoma, and rhabdomyosarcoma (RMS), it is anticipated that the target number may not be achievable in a reasonable timeframe; for these cohorts, the alpha and beta errors will be fixed at 15%. Consequently three different statistical designs will be a priori considered according to the expected response rate and incidence.


title: Study of the Prevalence of Cosavirus and Salivirus Infections, Two New Genera of Picornaviridae, In Infants

acronym: COSALE

summary:
Cosavirus and Salivirus are two new genera of Picornaviridae and are responsible for acute diarrhoea. They have been identified in the pathological stools of infants and immuno-compromised subjects on every continent with prevalences ranging from 2.8% to 8.8% depending on the virus, the cohort and the country studied.

To date, no study on these two viruses has been conducted in France to evaluate the circulation and the pathogenicity of these viruses in subjects with diarrhoea.

The aim of this study is thus to:

show that these viruses are in circulation in France in infants younger than 5 years old and that the proportions are similar to those reported in the literature.
confirm the relationship between the diarrhoea and the infection with these viruses.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Effects of a Series of Intensified Prevention Consultations on the Changes in Goals and Risk Factors in Hypertensive Patients at High Cardiovascular Risk

acronym: ESCAPE

summary:
Observational studies performed in France and abroad in hypertensive patients at high cardiovascular risk have shown a wide gap between the therapeutic targets reached in ambulatory patients and those set by guidelines. In primary prevention, in hypertensive patients at high cardiovascular risk (+ at least 2 risk factors), the gap is secondary to 1) the ignorance of the validated therapeutic targets and strategies, 2) the absence of global cardiovascular risk management, 3) the usual ambulatory medical practice, which is not adapted to a global cardiovascular prevention approach.

Objectives Principal. To demonstrate that a series of 5 specific prevention consultations over 2 years allows a greater number of hypertensive patients at high cardiovascular risk to reach the goals set by guidelines with no deterioration of their quality of life compared with no particular intervention.

Method Pragmatic, cluster-randomised controlled trial. At least 1904 high cardiovascular risk hypertensive patients will be included and followed up during two years by 268 teaching general practitioners from 23 regional teaching colleges. The regional teaching colleges will be randomised to avoid a contamination bias. The study will be coordinated by local coordinators at the college level.

Intervention In the intervention group, the investigators will have training, information, and feed back regarding the management of high risk hypertensive patients. The training will concern the targets to be reached, therapeutic strategies recommended by the AFSSAPS/HAS, and scientific data. The investigators will have an easy guide that can be used during consultations, and will be informed about tobacco withdrawal programs and education for improving diet, exercise and compliance.

In the control group, investigators will care for their patients as usual. End points Main: number of patients who reach all the therapeutic targets defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (T2D), and in the sub-group with hypertension and DT2.

Secondary: number of targets reached by the patients, changes in level of blood pressure, LDL-cholesterol, HbA1c, tobacco consumption, and use of aspirin if needed in the total population and its two subgroups, estimated cardiovascular risk, quality of life.

ReferenceCitation: Lebeau JP, Cadwallader JS, Vaillant-Roussel H, Pouchain D, Yaouanc V, Aubin-Auger I, Mercier A, Rusch E, Remmen R, Vermeire E, Hendrickx K. General practitioners' justifications for therapeutic inertia in cardiovascular prevention: an empirically grounded typology. BMJ Open. 2016 May 13;6(5):e010639. doi: 10.1136/bmjopen-2015-010639.

ReferenceCitation: Pouchain D, Lièvre M, Huas D, Lebeau JP, Renard V, Bruckert E, Girerd X, Boutitie F; French National College of Teachers in General Practice. Effects of a multifaceted intervention on cardiovascular risk factors in high-risk hypertensive patients: the ESCAPE trial, a pragmatic cluster randomized trial in general practice. Trials. 2013 Oct 1;14:318. doi: 10.1186/1745-6215-14-318.

lead_sponsor: Collège National des Généralistes Enseignants

location_facility:
French National College of GP Teatchers
Service de Pharmacologie Clinique


title: Observational Study of Bilateral Upper Limb Amputees in France

acronym: ARMOBS

summary:
In France, there is currently no data to directly estimate the number of bilateral upper limb amputations, their characteristics and therapeutic care.

By extrapolation from the Regional Institute of Physical Medicine and Rehabilitation (PMR) Nancy in 2005, the number of new cases of amputated patients with prosthetic fitting of the upper limb was estimated at 355. Epidemiological data from the 2009-2010 Annual Report of the LIMBLESS STATISTICS database (collection of quantitative clinical data and demographic of amputees patients referred by orthopaedic centres in the United Kingdom , whose population's characteristics are similar to France) identified 395 incident cases of upper limb amputation with, 6 bilateral amputations observed. The causes are varied: traumatic, infectious or related to diabetes. The population was relatively young, aged between 15 and 54 year old.

On this basis, the estimated number of new cases of bilateral upper limb amputations throughout France should therefore be about 40 incident cases over a 5-year period.

This observational study is aimed at collecting comprehensive and high quality data to describe the French population of bilateral upper limb amputees.

location_facility: Hospices Civils de Lyon, Hôpital Edouard Herriot


title: ACTIVHOP: Adapted Physical Activity, Health-related Quality of Life and Satisfaction With Care in Hospitalized Children; a Randomized Controlled Study

acronym: ACTIVHOP

summary:
The aim of this study is to assess the efficacy of adapted physical activity intervention on health-related quality of life and satisfaction with care in hospitalized children and adolescents.

This is a randomized controlled study. The hypothesis is that children practicing adapted physical activity during their hospitalization present a higher health-related quality of life and satisfaction with care than those who do not.

lead_sponsor: Central Hospital, Nancy, France

location_facility: University Hospital, Children's Hospital


title: A Retrospective Study of the Feasibility of Ambulatory Appendicectomy for Acute Appendicitis (Based on Data From the PMSI French National Hospital Information System) in the Adults Hospitalized Between December 2013 and December 2014

acronym: PMSIApp

summary:
Acute appendicitis is a frequent surgical emergency, with an estimated incidence of about 80,000 cases a year (in France). It mainly affects young adults but is associated with a low complication rate and a short stay in hospital. Ambulatory treatment is an innovative type of care in which the patient is hospitalized for less than 12 hours and does not stay overnight in hospital.

Ambulatory care is based on the guidelines issued by three French learned societies (the SFCD, the ACHBT and the AFCA) and has been defined by the French government as a national priority.

The literature data show that 20% of patients undergoing appendicectomy for acute appendicitis can be treated on an ambulatory basis. However, the success factors for short-stay care (hospitalization <24 hours) or ambulatory care (hospitalization <12 hours) have yet to be identified.

The investigators thus intend to perform a retrospective study of data from the PMSI French national hospital information system, in order to identify factors that are predictive of a length of hospital stay below 24 hours in patients having undergone appendicectomy for acute appendicitis during 2013 in France. The objective is to define the population of patients that could potentially benefit from ambulatory care.

status: Withdrawn


title: Phase 3 Study Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty

acronym: Cartipatch

summary: Numerous surgical techniques have been developped for the treatment of chondral and osteochondral defects of the knee. Among those techniques autologous chondrocyte transplantation (ACT) was promising but have potential drawbacks. A novel development by TBF is available. The aim of this randomized trial is to compared this new ACT technique to mosaicoplasty. Final outcomes were measured at 2 years using clinical evaluation scoring system (International Knee Documentation Committee), MRI and arthroscopy with biopsy. 64 patients are needed to detect a mean IKDC difference of at least 15 points with 90% power at a 5% alpha level. Twelve surgical centers in France are involved.

location_facility: Centre médico chirurgical de Dracy-Le-Fort

location_facility: Orthopaedic surgery Departement Brest University Hospital


type: Other Grant/Funding Number

title: Dysarthria in Parkinson's Disease: Lusophony vs. Francophony Comparison

acronym: FraLusoPark

summary:
Parkinson's disease (PD) affects between 1% and 2% of the world's population aged 60 and older; in Europe the prevalence is around 150 PD patients per 100,000 individuals. PD is classically characterized by a symptomatic triad that includes rest tremor, akinesia and hypertonia and although the motor expression of the symptoms involves mainly the limbs, the muscles implicated in speech production are also subject to specific dysfunctions. Motor speech disorders, so-called dysarthria, can thus be developed by PD patients. The main objective of our project is to evaluate the physiological parameters (acoustics), perceptual markers (intelligibility) and psychosocial impact of dysarthric speech in PD, in the context of language (French vs. Portuguese) modulations. Acoustic parameters are expected to be physiologically-based, linked with the motoric aspects of dysarthric speech. The same degree of impairment of such parameters should be associated with the pathology and be present universally in all patients, even if they speak different languages; that should be also the case of prosodic markers, whereas impairment of speech intelligibility may participate to the psychosocial impact in communication alteration.

PD patients will be enrolled in the study in Aix-en-Provence (N = 60) and Lisbon (N = 60). Their global motor disability will be assessed with dedicated clinical rating scales, without (off) and with (on) pharmacological treatment. Two groups of 60 healthy age-matched volunteers will provide the normal reference for between-group comparisons. Along with the off and on medication clinical examinations, several speech tasks will be recorded. Moreover, speech organ functions will also be assessed during the same examination. The psychosocial impact of dysarthria will be evaluated via self-questionnaires; it will be analysed a posteriori, as well as the speech intelligibility evaluation, and both will strengthen the overall speech assessments. This global investigation will represent a unique opportunity to provide the most precise and reliable description of PD patients' speech and its impacts on intelligibility and quality of life. Challenging and interdisciplinary aspects are combined in our project, which original cross-linguistic approach involves an international collaboration definitely new in the field of motor speech disorders.

ReferenceCitation: Pinto S, Cardoso R, Sadat J, Guimarães I, Mercier C, Santos H, Atkinson-Clement C, Carvalho J, Welby P, Oliveira P, D'Imperio M, Frota S, Letanneux A, Vigario M, Cruz M, Martins IP, Viallet F, Ferreira JJ. Dysarthria in individuals with Parkinson's disease: a protocol for a binational, cross-sectional, case-controlled study in French and European Portuguese (FraLusoPark). BMJ Open. 2016 Nov 17;6(11):e012885. doi: 10.1136/bmjopen-2016-012885.

ipd_sharing_description: Undecided

lead_sponsor: Centre National de la Recherche Scientifique, France

location_country: France Portugal

location_facility: Centre Hospitalier du Pays d'Aix - Service de Neurologie


title: Études Observationnelles Des conséquences néonatales et pédiatriques de l'Infection à Virus Zika au Cours de la Grossesse Pendant l'épidémie Des départements français d'Amérique de l'année 2016

acronym: ZIKA-DFA-BB

summary:
The Zika epidemic has spread into the three French Overseas Departments in the Caribbean (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical data for the evaluation of potential complications due to having ZIKV infection during pregnancy.

This study is meant to collect, within usual care practices, clinical and paraclinical information (including imaging and laboratory results) as well as biological samples allowing the precise description of the consequences of ZIKV infection during pregnancy.

This study is the 2nd arm of a global research program in the 3 French Overseas Departments in the Caribbean. It is complementary to the first arm (ZIKA-DFA-FE) consisting in the follow-up of women in the French Overseas Departments who are pregnant during the Zika epidemic period.

The study population is made up of infants born during and up to 9 months after the end of the Zika epidemic period in the French Overseas Departments.

The data and biological specimens collected for this project will be done so through the recommended standard of care which has been put in place considering the ZIKV epidemic in the 3 French Overseas Departments, upholding existing recommendations (profession and/or recommendation from the public health authorities)

ReferenceCitation: Grant R, Fléchelles O, Tressières B, Dialo M, Elenga N, Mediamolle N, Mallard A, Hebert JC, Lachaume N, Couchy E, Hoen B, Fontanet A. In utero Zika virus exposure and neurodevelopment at 24 months in toddlers normocephalic at birth: a cohort study. BMC Med. 2021 Jan 21;19(1):12. doi: 10.1186/s12916-020-01888-0.

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

location_facility: CH de l'Ouest Guyanais Franck Joly (CHOG)


title: Knowledge and Perception of Resistance to Antimicrobials in French Healthcare Facilities

acronym: PerceptR

summary: The objectives of this survey are to determine the level of antimicrobial resistance knowledge and perception of health care workers (HCW) in France, to measure the impact of health care facilities (HCF) and to identify the drivers and barriers to change. To achieve this goal, a cross-sectional survey on one day with a self-administered questionnaire and semi-structured interviews with HCWs is proposed. This study will be planned in 60 different HCFs randomly selected and expected to include of 2,100 to 10,000 respondents.

ReferenceCitation: Vaillant L, Birgand G, Esposito-Farese M, Astagneau P, Pulcini C, Robert J, Zahar JR, Sales-Wuillemin E, Tubach F, Lucet JC; PerceptR Study group. Awareness among French healthcare workers of the transmission of multidrug resistant organisms: a large cross-sectional survey. Antimicrob Resist Infect Control. 2019 Nov 12;8:173. doi: 10.1186/s13756-019-0625-0. eCollection 2019.


acronym: OFICE

summary:
Brief Summary: The purpose of the OFICE registry is to characterize and describe the CLL patients' population from the Finistere area and evaluates the association between different patient characteristics, prognosis and treatment patterns.

Detailed Description: OFICE is a single center, prospective, observational registry of CLL patients designed to provide a general description of the CLL patients' population from the Finistere area, France. The registry will also provide information on the association of cytogenetic and immunophenotypic characteristics with disease progression, as well as treatment patterns and healthcare resource utilization. These data will be accessible and beneficial for researchers and physicians and will help guide clinical practice and future clinical or fundamental studies.

ReferenceCitation: Debant M, Burgos M, Hemon P, Buscaglia P, Fali T, Melayah S, Le Goux N, Vandier C, Potier-Cartereau M, Pers JO, Tempescul A, Berthou C, Bagacean C, Mignen O, Renaudineau Y. STIM1 at the plasma membrane as a new target in progressive chronic lymphocytic leukemia. J Immunother Cancer. 2019 Apr 23;7(1):111. doi: 10.1186/s40425-019-0591-3.

ReferenceCitation: Bagacean C, Tempescul A, Ternant D, Banet A, Douet-Guilbert N, Bordron A, Bendaoud B, Saad H, Zdrenghea M, Berthou C, Paintaud G, Renaudineau Y. 17p deletion strongly influences rituximab elimination in chronic lymphocytic leukemia. J Immunother Cancer. 2019 Jan 29;7(1):22. doi: 10.1186/s40425-019-0509-0.


title: After Cancer in the Military: What Happens After Long-term Sick Leave

acronym: APCAM-CLDM

summary:
In recent decades, early diagnosis and improved treatment have led to increased survival for most people with cancer. This improved survival has led to more attention being paid to the quality of life of these people, and to their reintegration into social and professional life. In France, 3.8 million people are treated or in remission from cancer in 2017. Among the 400,000 new patients diagnosed with cancer each year in France, 160,000 (40%) are in professional activity.

Cancer treatments induce after-effects that can be felt several months or even years after the diagnosis and have an impact on life. In a study of patients in remission from cancer at 12 months after diagnosis, 47 to 53% of patients had changed jobs or stopped working. In another Finnish study, 26% of patients had decreased physical ability and 19% had decreased mental ability to work five years after cancer diagnosis.

In France, studies that have evaluated the impact of cancer on employment and the factors associated with return to work after cancer are still rare: the VICAN study showed that among people in work at the time of diagnosis, 20% were no longer working five years later.

With an estimated annual incidence of approximately 400 new cancers per year, the military population is also affected by cancer. Professional reintegration after cancer is of particular concern to the military. The specificity and requirements of the military condition can indeed make this reintegration more difficult. Regular or even intense physical activity is indeed essential but can be difficult after undergoing anti-cancer treatments. Moreover, external operations and many activities are conditioned by the obtaining of medical skills, which are sometimes incompatible with the state of health of patients recently treated for a neoplastic pathology. The studies previously carried out concerning the professional future after cancer do not seem to us to be transposable to the military population. To our knowledge, no study has evaluated occupational reintegration in military personnel after cancer.

The aim of this study is to evaluate the difficulties encountered during the post-cancer professional reintegration of military personnel in terms of fatigue, aptitude and advancement, in order to anticipate them and possibly remedy them. The identification of these difficulties will eventually allow to anticipate them and possibly to remedy them via an adapted post-cancer professional reintegration pathway.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Sainte-Anne


title: Activity and Safety of Regorafenib in Patients With Metastatic Soft Tissue Sarcoma Previously Treated With Anthracycline-based Chemotherapy : a Multinational, Randomized, Phase II, Placebo-controlled Trial

acronym: REGO-SARC

summary:
This is an international (France, Austria and Germany), randomized, double-blind, placebo-controlled, phase II study to evaluate the efficacy and safety of regorafenib in patients with histologically proven metastatic and/or unresectable Soft Tissue Sarcoma (STS) after failure or intolerance to doxorubicin (or other anthracycline).

Five cohorts will be defined:

Cohort A: Liposarcoma Cohort B: Leiomyosarcoma Cohort C: Synovial sarcoma Cohort D: other sarcomas (see Appendix C) Cohort E: Leiomyosarcoma, Synovial sarcoma and other sarcomas listed in Appendix C previously treated with pazopanib Approximately 226 patients who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to one of the treatment groups.

ReferenceCitation: Penel N, Mir O, Wallet J, Ray-Coquard I, Le Cesne A, Italiano A, Salas S, Delcambre C, Bompas E, Bertucci F, Saada-Bouzid E, Chaigneau L, Chevreau C, Brodowicz T, Decoupigny E, Vanseymortier M, Laroche L, Taieb S, Le Deley MC, Blay JY. A double-blind placebo-controlled randomized phase II trial assessing the activity and safety of regorafenib in non-adipocytic sarcoma patients previously treated with both chemotherapy and pazopanib. Eur J Cancer. 2020 Feb;126:45-55. doi: 10.1016/j.ejca.2019.12.001. Epub 2020 Jan 6.

ReferenceCitation: Longué M, Cabarrou B, Wallet J, Brodowicz T, Roché H, Boher JM, Delord JP, Penel N, Filleron T. The importance of jointly analyzing treatment administration and toxicity associated with targeted therapies: a case study of regorafenib in soft tissue sarcoma patients. Ann Oncol. 2018 Jul 1;29(7):1588-1593. doi: 10.1093/annonc/mdy168.

ReferenceCitation: Berry V, Basson L, Bogart E, Mir O, Blay JY, Italiano A, Bertucci F, Chevreau C, Clisant-Delaine S, Liegl-Antzager B, Tresch-Bruneel E, Wallet J, Taieb S, Decoupigny E, Le Cesne A, Brodowicz T, Penel N. REGOSARC: Regorafenib versus placebo in doxorubicin-refractory soft-tissue sarcoma-A quality-adjusted time without symptoms of progression or toxicity analysis. Cancer. 2017 Jun 15;123(12):2294-2302. doi: 10.1002/cncr.30661. Epub 2017 Mar 10.

ReferenceCitation: Mir O, Brodowicz T, Italiano A, Wallet J, Blay JY, Bertucci F, Chevreau C, Piperno-Neumann S, Bompas E, Salas S, Perrin C, Delcambre C, Liegl-Atzwanger B, Toulmonde M, Dumont S, Ray-Coquard I, Clisant S, Taieb S, Guillemet C, Rios M, Collard O, Bozec L, Cupissol D, Saada-Bouzid E, Lemaignan C, Eisterer W, Isambert N, Chaigneau L, Cesne AL, Penel N. Safety and efficacy of regorafenib in patients with advanced soft tissue sarcoma (REGOSARC): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2016 Dec;17(12):1732-1742. doi: 10.1016/S1470-2045(16)30507-1. Epub 2016 Oct 14.

ReferenceCitation: Brodowicz T, Liegl-Atzwager B, Tresch E, Taieb S, Kramar A, Gruenwald V, Vanseymortier M, Clisant S, Blay JY, Le Cesne A, Penel N. Study protocol of REGOSARC trial: activity and safety of regorafenib in advanced soft tissue sarcoma: a multinational, randomized, placebo-controlled, phase II trial. BMC Cancer. 2015 Mar 14;15:127. doi: 10.1186/s12885-015-1143-y.

lead_sponsor: Centre Oscar Lambret

location_country: Austria France

location_facility: Institut de Cancérologie Lucien Neuwirth (ICL)

location_facility: Krankenhaus der Barmherzigen Schwestern Linz


title: Psychological Impact of the Covid-19 Pandemic on Student Nurses :Prevalence and Risk Factors of Acute Post-traumatic Stress Symptoms 1 Month After the Epidemic Peak

acronym: StudentCov

summary: The World Health Organization (WHO) declared in early 2020 the emergence of a new highly contagious SARS-CoV-2 coronavirus responsible for a global public health emergency. In France, the first cases of contamination have been reported since the end of January 2020, and the first death in mid-February 2020. Then, data published by Public Healh France reported an increasing and rapidly exponential number of contaminations. First cases have been identified on a cluster mode, then rapidly spreading in some French departments and regions, indicating rapid kinetics of virus spread. Given the magnitude of the situation both French territory and neighboring European territories (mainly Italy), the government mobilized the entire health system to critically manage this epidemic. This exceptional and unprecedented pandemic deeply impacted the health structures, disrupting healthcare organizations. All caregivers, including all student nurses, actively participated in the mobilization and strengthening of care teams. The health crisis exposed the population of caregivers to potentially traumatic events which can have major repercussions on their health state. The description and identification of the risk factors of the occurrence of post traumatic stress disorders in student nurses during the health crisis would allow to provide avenues for improving training devices and to facilitate health workers access to specific psychological care particularly dedicated to the student nurses population needs.

lead_sponsor: Versailles Hospital

location_facility:
Toulouse University Hospital
Versailles hospital


title: Morbidity and Mortality Associated With the Care Journey in Children and Adolescents With Hyperthyroidism

acronym: MOTHYRE

summary:
"Early paediatric Basedow disease is one of the rare endocrine diseases for which the Reference Centre for Rare Endocrine Growth Diseases, was approved by the Ministry of Health in 2005. In addition, the study will benefit from the expertise of public Health France (SFP). This study is therefore part of the missions of these partners (reference centre for endocrine growth diseases and Public Health France).

For several years, our group has been interested in defining the evolutionary profile of these patients. A national study on short- and long-term patient follow-up has already been conducted, which has been the subject of two international publications29,30, as well as a study on a specific clinical form of the disease 24. This work was made possible thanks to the collaboration of paediatric clinical centres within the Reference Centre and Competence Centre for Rare Endocrine Diseases Network. The present study planned in France will make it possible to accurately characterize the care pathway and the frequency of complications associated with it at the national level.


title: Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection

acronym: Onco-VOC

summary:
Bronchopulmonary cancer, with 39 000 new cases and 30 000 deaths per year, is a main issue in public health in France. It is the leading cause of cancer death in France. A lot of progress in medical care has been made, but surgery remains the most effective treatment, when it is still possible. The goal is to detect and manage the lung cancer as early as possible. Alongside screening strategies by annual thoracic scanner, new approaches with innovative technologies open up for cancer detection and therapeutic follow-up.

The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The volatolomic analysis can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases.

The composition of VOC in exhaled air and sweat is altered in patients with lung cancer. The VOC analysis and their variation could be used particularly in the follow-up of patients treated for lung cancer.

The purpose of this clinical research is to identify the VOCs related to lung cancers by comparing the VOC profiles in exhaled air and in sweat from patients diagnosed with localized lung cancer before and after resection surgery.

primary_purpose: Other

lead_sponsor: Hopital Foch


title: Automatic Remifentanil Administration Guided by the Analgesia Nociception Index During Propofol Anesthesia

acronym: ANI-LOOP

summary: Prospective Randomized Monocentric Clinical Trial during propofol anesthesia. The aim of the study is to test whether the use of a medical device designed to automatically administer remifentanil during surgery based on expert rules and continuous reading of heart rate, blood pressure and the Analgesia Nociception Index results in lower overall remifentanil administration versus standard practice.

lead_sponsor: University Hospital, Lille

intervention_type: Device


title: Pathological Findings in Critically-ill Patients Who Died From SARS-CoV-2 Related Acute Respiratory Distress Syndrome

acronym: HISTOCOVID

summary: The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a new coronavirus discovered in December 2019 in Wuhan, China and currently responsible of a worldwide outbreak and the death of more than 55,000 patients in France. The more severe form of COVID-19 disease induces a pneumonia with profound hypoxemia which may require invasive mechanical ventilation. It is estimated that 5% of COVID-19 patients are admitted to the Intensive Care Unit (ICU) for management. Hospital mortality in patients who develop severe acute respiratory distress syndrome (ARDS) ranges between 40% and 60%. The investigators purpose to investigate the pathological findings of COVID-19 patients who died from ARDS in the ICU by doing post-mortem lung biopsies

ipd_sharing: Yes

lead_sponsor: Nantes University Hospital

location_facility:
CH Cholet
CH Cergy Pontoise
CHU Clermont-Ferrand
CH Compiègne-Noyon
CH Belfort
CHU Bordeaux
Hopital Sainte Camille
CH Angoulême
CH Reims
Hopital Saint-Antoine APHP
CHU Rennes
Hopital Louis Mourier APHP
CH Argenteuil
CH Montélimar
Hopital Foch
Hopital Antoine Béclère APHP
Hopital Saint-Louis APHP
CHU Nice
CH Amiens
CH Annecy
Hopital Georges Pompidou APHP
CHR Orléans
GHEF Marne La Vallée
CH Poissy
CH Melun
CH Troyes
CH Vannes
Hopital La Pitié Salpetrière APHP
Hopital Privé d'Antony
Hopital Privé Claude Galien
CHD Vendée
Marseille Hopital Nord APHM
Nantes University Hospital
Hopital Necker APHP
CH Cahors
CH Saint-Brieuc
CHU Saint-Etienne
CHRU Tours
CH Versailles
Hopital Lyon Sud
Hopital Cochin APHP
Hôpital Lyon Sud
Angers University Hospital
CH Ambroise Paré APHP


title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in France.

summary: The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccines in France.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer


title: Comparison of Patient Care Management Strategies of Heart Failure in the Rhône-Alpes Region. A Clinical and Economic Study.

acronym: EFFICARD

summary:
The heart failure is a chronic pathology with prevalence from 2 to 3% of general population, a death rate of 50% at 6 months for patients with stage IV, and a probability of death or hospitalization or emergency consultation of 40% at 3 years. The care of patients is heterogeneous, especially in light of the organization of therapeutic education offered to patients and patient monitoring modalities.

The aim of this study is to investigate the management strategies for patients with chronic heart failure stage III or IV NYHA, and heart failure patients with stage II NYHA with previous hospitalization for heart failure.

This is a longitudinal observational multicenter study comparing a management strategy including patient education and monitoring as part of a hospital dedicated organization and an organization of care as usually done in France.

The primary endpoint was a composite endpoint of morbidity and mortality involving deaths, unplanned readmissions and emergency visits for heart failure.

The expected number of patients is 720 patients (360 per strategy). The follow-up duration of 24 months.

primary_purpose: Health Services Research

lead_sponsor: Hospices Civils de Lyon


title: Evaluation of a Tdap-IPV Vaccination Remedial Strategy on Vaccination Coverage in Patients 65 Years of Age or Older in the French County of Sarthe

acronym: HOSPIVAC

summary:
In France, vaccination coverage is insufficient (in 2002, 71.2% coverage for tetanus, 41.9% for poliomyelitis and 33.7% for diphteria). These numbers decrease significantly with age: coverage for people aged over 65 was 60.5%, 13.3% and 10.5% for tetanus, poliomyelitis and diphteria coverage respectively.

The primary objective of this study is to evaluate the impact of a hospital based vaccination remedial strategy for Tdap-IPV (tetanus, diphteria, pertussis and polio vaccine) in patients 65 years of age or older.

Secondary objectives are to measure the vaccination coverage of patients aged 65 years or older hospitalised in a medical ward in our hospital, to evaluate their knowledge of their vaccination coverage, and to evaluate the socio-demographic factors associated with vaccination coverage.

lead_sponsor: Centre Hospitalier le Mans


title: Daycare Environmental Exposure to Cleaning Products and Respiratory Health in Young Children and Daycare Workers

acronym: CRESPI

summary:
CRESPI - RESPIratory health of Children in daycare

The CRESPI study, will be a cohort of 1500/2000 children attending daycare in Paris region, and will be initiated in November 2019.

The aim of the project is to study the impact of environmental exposures to cleaning products and disinfectants on respiratory health of infants and toddlers (< 3 years) in daycares

Two specific aims were defined:

evaluate environmental exposure to cleaning products by complementary and innovative tools: air quality measurements in daycares, specific standardized questionnaire, identification of compounds of the products via a database and a Smartphone application to scan bar codes and inform on product use
evaluate the impact of early exposure in daycares and at home on respiratory health of young children


title: Post-market Clinical Follow-up Study Evaluating the Efficacy and Safety of LifeVest in Real-life Settings in France

acronym: WEARIT France

summary: This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.

ReferenceCitation: Garcia R, Combes N, Defaye P, Narayanan K, Guedon-Moreau L, Boveda S, Blangy H, Bouet J, Briand F, Chevalier P, Cottin Y, Da Costa A, Degand B, Deharo JC, Eschalier R, Extramiana F, Goralski M, Guy-Moyat B, Guyomar Y, Hermida JS, Jourda F, Lellouche N, Mahfoud M, Manenti V, Mansourati J, Martin A, Pasquié JL, Ritter P, Rollin A, Tibi T, Yalioua A, Gras D, Sadoul N, Piot O, Leclercq C, Marijon E. Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study. Europace. 2021 Jan 27;23(1):73-81. doi: 10.1093/europace/euaa268.

lead_sponsor: Zoll Medical Corporation

location_facility:
Clinique PASTEUR
Hôpital Européen Georges Pompidou


title: Hantavirus Nephropathy in North-Eastern France : Severity Risk Factors and Prognostic Tools

acronym: HANTA-NE

summary:
Hantaviruses are emerging pathogens responsible for hemorrhagic fever with renal syndrome. Severity risks factors aren't consensual in litterature, mostly related to scandinavian cohorts. A prognostic score was created to help patient's orientation in healthcare system but wasn't independantly validated (Hentzien, Emerging infectious diseases 2018).

This retrospective cohort of hantavirus infected hospitalized adults patients in the north-eastern quarter of France between 2013 and 2022 will specify the kidney damage during infection and risk factors for a severe form (defined par acute kidney injury KDIGO 3). The previous prognostic score performance will be evaluated in this cohort.


title: Epidemiology of Congenital Heart Disease in France : EPIDEMIO-CHD

acronym: EPIDEMIO-CHD

summary:
Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Since the 1980s, France has been a pioneer in neonatal CHD surgery (Pr. Fontan, Pr. Lecomte, Pr. Serraf, etc.), in prenatal diagnosis, and in interventional cardiac catheterization.

Actually, first children operated for complex CHD have reached adulthood and a new epidemiology of CHD is emerging. Currently, one of the public health challenges is the need to maintain appropriate follow-up and to avoid disruption of care during the transition from adolescence to adulthood. Thus, the national health authorities (DGOS) recently certified a national network of expert centers for complex CHD (M3C).

In addition, under the leadership of the French Society of Cardiology, the sub-specialty of Pediatric and Congenital Cardiology has been recognized.

However, while North American and North European countries have published their updated data on the main indicators of CHD morbidity and mortality, no study has reported epidemiology of CHD in France.

Currently, available data are approximate, estimating that 200,000 children and 250,000 adults would be living in France with a CHD. Nevertheless, no information is available on hospitalizations, type of CHD, their follow-up, possible disruption in care, and morbidity and mortality in patients with CHD in France. This epidemiological study will use the national health insurance hospital database to answer these questions.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Evaluation of Impact of Disease and Visual Disability on Quality of Life and Loss of Independence of Patients Living in France With Leber's Hereditary Optic Neuropathy (LHON) Through Qualitative and Quantitative Data Collection

summary:
Leber's hereditary optic neuropathy (LHON) is a rare mitochondrial genetic disorder characterized by optic nerve atrophy due to the degeneration of retinal ganglion cells, which leads to acute visual loss.

Males are more likely to develop optic neuropathy than women. They experience blurring or clouding of vision in one eye. The fellow eye develops similar symptoms sequentially with a delay of weeks.

This sudden vision loss has devastating consequences on the life course of young men, with the impact of LHON on their quality of life and loss of independence.

Yet, data describing the impacts of LHON on the life-course of patients is lacking, with very little data available in the literature.

This study aims to understand the life of patients living with LHON disease through the analysis of the impact of LHON on the quality of life and loss of independence of patients living in France and to accurately describe the consequences of the disease on their social, familial and professional life.

ReferenceCitation: Cui S, Jiang H, Peng J, Wang J, Zhang X. Evaluation of Vision-Related Quality of Life in Chinese Patients With Leber Hereditary Optic Neuropathy and the G11778A Mutation. J Neuroophthalmol. 2019 Mar;39(1):56-59. doi: 10.1097/WNO.0000000000000644.

ReferenceCitation: Kirkman MA, Korsten A, Leonhardt M, Dimitriadis K, De Coo IF, Klopstock T, Griffiths PG, Hudson G, Chinnery PF, Yu-Wai-Man P. Quality of life in patients with leber hereditary optic neuropathy. Invest Ophthalmol Vis Sci. 2009 Jul;50(7):3112-5. doi: 10.1167/iovs.08-3166. Epub 2009 Feb 28.

ReferenceCitation: Newman NJ. Hereditary optic neuropathies: from the mitochondria to the optic nerve. Am J Ophthalmol. 2005 Sep;140(3):517-23. Review.

ReferenceCitation: Newman NJ, Yu-Wai-Man P, Carelli V, Biousse V, Moster ML, Vignal-Clermont C, Sergott RC, Klopstock T, Sadun AA, Girmens JF, La Morgia C, DeBusk AA, Jurkute N, Priglinger C, Karanjia R, Josse C, Salzmann J, Montestruc F, Roux M, Taiel M, Sahel JA. Intravitreal Gene Therapy vs. Natural History in Patients With Leber Hereditary Optic Neuropathy Carrying the m.11778G>A ND4 Mutation: Systematic Review and Indirect Comparison. Front Neurol. 2021 May 24;12:662838. doi: 10.3389/fneur.2021.662838. eCollection 2021.

ReferenceCitation: Yu-Wai-Man P, Turnbull DM, Chinnery PF. Leber hereditary optic neuropathy. J Med Genet. 2002 Mar;39(3):162-9. Review.

lead_sponsor: Argo Sante


title: Impact of COVID-19 on Unplanned Admissions for Acute Cardiovascular and Neurovascular Conditions in France

acronym: COVUSI

summary:
The COVID-19 pandemic has had dramatic effects on health systems and on non-COVID health care.

Using French inpatient claims data and retrospectively collected clinical data, the investigators will assess the changes in hospital admissions for acute cardiovascular and neurovascular conditions in France during and after the national lockdown.


type: Registry Identifier

title: Epidémiologie et Conditions de Vide liées au Covid-19 STUDY OF THE COVID-19 (SARS-CoV-2) EPIDEMIC AND SOCIO-ECONOMIC LIVING

acronym: EpiCov

summary: EpiCov is a population-based cohort which aims to provide national and regional estimates of seroprevalence of SARS-CoV-2 infection and analyse relations between living conditions and the dynamics of the epidemic in France. The study population is a random sample of individuals aged 15 years and older, excluding people living in residences for the elderly and living in jail. The participants are recruited from the French national tax register and is representative of the population living in France. Home self-samples on Dried Blood Spots (DBS) for IgG and neutralizing antibodies detection were offered to a random national sub-sample of 12,114 in the 1st round of the EPICOV survey (May 2020) and to all respondents in the 2nd round (November 2020), including also serological testing for all members (≥ 6 years old) of household for 20% of index participants. A third round was perfomed in June-July 2021, without serological measurements. Overall, 134,391 participants have been enrolled in first-round (May 2020). Among them, 107 759 participated to the second round (November 2020) and 85 074 in third round (June 2021). The next wave is expected in March-april 2022.

ipd_sharing_description:
The EpiCov data is available for research purpose, 9 months after overall completion of one round. Access to anonymized individual data may be available before the planned period of open access : specific project has to be presented to the EpiCov exploitation committee : if accepted, it needs approval of ethics and reglementary Committee for researchers who meet the criteria for access to data.

The first round, and will be available by March 2022 concerning the second round for research purpose on CASD (https://www.casd.eu/), after submission to approval of French Ethics and Regulatory Committee procedure (Comité du Secret Statistique, CESREES and CNIL).


title: Non-interventional Study Describing Epidemiology, Clinical Characteristics, Prognosis and Healthcare Costs of PF-ILD and SSc-ILD Patients in France, 2010-2017

acronym: PROGRESS

summary:
Interstitial lung diseases (ILDs) are a heterogeneous group of disorders, which encompass a wide range of conditions. In some patients with fibrosing ILDs, a progressive phenotype similar to that observed in idiopathic pulmonary fibrosis (IPF) may develop during the course of the disease (PF-ILD), including patients with systemic sclerosis (SSc)-related ILD.

The aim of the study is to estimate the incidence and prevalence and to describe the characteristics of patients diagnosed with non-IPF PF-ILD and SSc-ILD, to describe the natural course of disease, and to explore the correlation between mortality and Forced Vital Capacity (FVC) of the patients with non-IPF PF-ILD.

This study will be based on two data sources: the French national medico administrative database (SNDS) and the ILD cohort from the National French center for rare pulmonary diseases in Lyon, France.

ReferenceCitation: Cottin V, Larrieu S, Boussel L, Si-Mohamed S, Bazin F, Marque S, Massol J, Thivolet-Bejui F, Chalabreysse L, Maucort-Boulch D, Jouneau S, Hachulla E, Chollet J, Nasser M. Epidemiology, Mortality and Healthcare Resource Utilization Associated With Systemic Sclerosis-Associated Interstitial Lung Disease in France. Front Med (Lausanne). 2021 Aug 30;8:699532. doi: 10.3389/fmed.2021.699532. eCollection 2021.

ReferenceCitation: Nasser M, Larrieu S, Boussel L, Si-Mohamed S, Bazin F, Marque S, Massol J, Thivolet-Bejui F, Chalabreysse L, Maucort-Boulch D, Hachulla E, Jouneau S, Le Lay K, Cottin V. Estimates of epidemiology, mortality and disease burden associated with progressive fibrosing interstitial lung disease in France (the PROGRESS study). Respir Res. 2021 May 24;22(1):162. doi: 10.1186/s12931-021-01749-1.

ReferenceCitation: Nasser M, Larrieu S, Si-Mohamed S, Ahmad K, Boussel L, Brevet M, Chalabreysse L, Fabre C, Marque S, Revel D, Thivolet-Bejui F, Traclet J, Zeghmar S, Maucort-Boulch D, Cottin V. Progressive fibrosing interstitial lung disease: a clinical cohort (the PROGRESS study). Eur Respir J. 2021 Feb 11;57(2). pii: 2002718. doi: 10.1183/13993003.02718-2020. Print 2021 Feb.


title: Statins and Risk of Myocardial Infarction in Real Life in France

summary: The main objective of this case-referent study is to assess the impact of statins usage on the risk of having a first myocardial infarction (MI) in a real life situation in France

lead_sponsor: AstraZeneca


title: Genetic Polymorphisms in Idiopathic Mitral Valve Prolapse :A French Prospective Study Using a Genome Wide Analysis

acronym: MVP-France

summary: This prospective nation-wide (France) study aims to search for susceptibility genes in MVP using a genome wide analysis and comparing results obtained in 1000 patients with MVP and 1000 non-MVP subjects.

lead_sponsor: French Cardiology Society

location_facility:
Institut Hospitalier Jacques Cartier
Clinique Saint Augustin
Hôpital de la Timone
Hôpital Gabriel Montpied
Hôpital Arnaud de Villeneuve
Hôpital Cochin
Hôpital Ambroise Paré
Hôpital Pontchaillou
Hôpital Pitié Salpêtrière
Hôpital Sud
Hôpital Charles Nicolle
CHU Nancy
Hôpital Front-Pré
Hôpital de la Cavale Blanche
Hôpital Bichat
Hôpital Dupuytren
Hôpital Cardiologique
Hôpital Saint Antoine
Hôpital Cardiologique du Haut Lévêque
Hôpital Européen Georges Pompidou
Hôpital du Bocage
Hôpital Rangueil
Hôpital Lariboisière
Groupement Hospitalier Est
Hôpital G and R Laennec
Hôpital Henri Mondor

intervention_type: Genetic


title: Monitoring prEscriptiondruG Abuse Using DOctor Shopping bEhavior

acronym: MEGADOSE

summary:
Prescription drug abuse is a major challenge in public health, in particular in countries such as France, one of the main consumers of medication in Europe. A single source of information is rarely sufficient to measure such a complex phenomenon. This project entitled MEGADOSE (Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhavior) may complete efficiently the available data from the addictovigilance centres allowing the health authorities (French Drug Agency) to answer to the main general questions (What are the main prescription drug abused in France? What are the national trends in prescription drug abuse? What is the impact of a public health measure on prescription drug abuse). This project constitutes the opportunity of "extending" the application of our tool (the DS method) on a French national database with a minimal risk since this method has already been validated and applied on different geographic areas, on different drugs and at different levels of analysis. The project would also be integrated in routinely as a useful tool included in the addictovigilance monitoring, also allowing a multi-approach approach and the monitoring of policy and practice interventions implemented by the French Drug Agency.

The project MEGADOSE is also in accordance with the main topic of the projects funded by ANSM related to drug misuse in particular: development and identification of systems and tools able to detect earlier misuse phenomenon; analysis of the impact of communications, guidelines, decisions to health authorities and patients

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Analysis of Capillary Retinal and Papillary Vascularization in Patients With Amyotrophic Lateral Sclerosis

acronym: CAPISLA

summary:
Amyotrophic Lateral Sclerosis, or Charcot's disease, is a neurodegenerative disease affecting motor neurons. The disease affects between 5 and 10 people per 100,000 in the world, nearly 7,000 patients are affected in France. The only therapeutic treatment available to date in France is riluzole, which slows the progression of the disease. Amyotrophic Lateral Sclerosis is the first degenerative disease affecting motor neurons. However, recent evidence suggests that the impairment extends beyond motor neurons alone.

Optical Coherence Tomography analyzes made it possible to highlight ophthalmologic damage in patients with Amyotrophic Lateral Sclerosis, in particular at the macula and papilla, although some results are contradictory.

No angiographic Optical Coherence Tomography analysis has been performed to date in patients with Amyotrophic Lateral Sclerosis. However, in the hypothesis of microvascular involvement participating in the pathophysiology of neurodegeneration in Amyotrophic Lateral Sclerosis, these examinations could provide relevant clinical and pathophysiological data by studying the retinal microvascularization of patients with the disease.

lead_sponsor: University Hospital, Angers


title: Serotype Distribution in Hospitalized Adult With Pneumococcal Community Acquired Pneumonia in France

acronym: CAP'Hospi

summary: CAP'Hospi is an observational, multicentric study in France which primary objective is to describe the proportion of Community Acquired Pneumonia due to serotypes included in PCV20 among adults hospitalized for CAP

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


title: Cerebellum and Cortical Plasticity: the Case of Dystonia

acronym: CERDYS

summary:
Purpose

- Objective : Sensorimotor adaptation allows the modification of the motor command taking into account the errors detected during execution of prior movements. It involves a large cortico-subcortical network. Isolated lesions of this network do not systematically alter sensorimotor adaptation except for cerebellar lesions. The cerebellum is thus a key structure for sensorimotor adaptation. However, the link between cerebellar and the cortical plasticity underlying sensorimotor adaptation remain unknown. Alteration of sensorimotor adaptation is associated with dystonia but it is unclear whether it is a cause or consequence of dystonia. It has been hypothesized that the abnormal plasticity observed in dystonia could account for the associated alteration of sensorimotor adaptation.

Classically, basal ganglia dysfunction is considered to be crucial for dystonia pathogenesis. However, recent studies suggest that the involvement of the cerebellum may also be important in this setting. In primary dystonia, imaging studies showed abnormal cerebellar activation during sensorimotor adaptation tasks and neurophysiological studies demonstrated a decrease of cerebellar output.

The aim of this study is to investigate the role of the cerebellum in the cortical plasticity underlying sensorimotor adaptation both in healthy subjects (normal plasticity) and in dystonic patients (abnormal plasticity).

- Methods: Paired associative stimulation PAS consists in repetitive pairing of a peripheral nerve and a cortical stimulation. This kind of stimulation has been designed to induce artificial plasticity that can be easily measured. This PAS induced sensorimotor plasticity is exacerbated and has lost its topographical specificity in dystonic patients.TMS using trains of TMS pulses (rTMS) can be applied on the cerebellum to modulate its output. We will test the effect of rTMS induced modulation (cTBS- inhibitory, iTBS-excitatory, sham) of the cerebellar output on PAS induced plasticity in patients with dystonia and healthy control.

We will also assess the acute effect of the rTMS induced modulation of the cerebellar output on the dystonic symptoms and on the performance at a validated sensorimotor adaptation task. This will be done by double blind post-hoc scoring of the dystonia (BFM or TWSTRS) on standardized videorecording and measurement of the performance at the task after each rTMS session (cTBS, iTBS, sham).

Finally, we will assess the variation of PAS effect on other parameters reflecting cortical excitability after each rTMS session (cTBS, iTBS, sham).

location_facility: Hpôpital Pitié Sapétrière - U 975 Plate forme " Pole Exploration de l'homme : Gait, Equilibrium, Posture, and Movement "


title: Incidence of Covid-19 in School Children During the Pandemic Period in Nice

acronym: COVIDECOLE

summary:
The Coronavirus disease 2019 (COVID-19) is causing a global pandemic with high morbidity and mortality among adults and mainly the elderly. Children seem to be little or not affected by this infection. It is estimated that children could be asymptomatic or pauci-symptomatic carriers and thus be vectors of the disease. This is why measures to close schools and confine populations have been decreed in a large number of countries, including France. However, there are only a few data on the prevalence of COVID19 disease in children. The deconfinement strategy depends on data on the prevalence of the disease, especially in children.

Investigators propose to evaluate the incidence of Covid-19 in preschool and elementary schools children in the city of Nice (South of France) during the pandemic period using a local prospective study of 914 children

lead_sponsor: Fondation Lenval


title: Feasibility in France of a Mindfulness-based Group Therapy for Adolescents With Chronic Pain

acronym: PEACEFULL

summary: The main objective is to study the feasibility of a program for the management of chronic painful adolescents in meditation groups. This program is an adaptation of the MBI-A (Mindfulness-based intervention for adolescent) program developed in another socio-cultural context (i.e. in Canada). The secondary objectives will be to study the effect of a mindfulness meditation program for adolescents on pain, quality of life, acceptance of pain, functional disability, catastrophism, anxiety-depression, emotional repercussions and acceptance of mindfulness

ReferenceCitation: Bawa FL, Mercer SW, Atherton RJ, Clague F, Keen A, Scott NW, Bond CM. Does mindfulness improve outcomes in patients with chronic pain? Systematic review and meta-analysis. Br J Gen Pract. 2015 Jun;65(635):e387-400. doi: 10.3399/bjgp15X685297. Review.

ReferenceCitation: Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.

ReferenceCitation: Zenner C, Herrnleben-Kurz S, Walach H. Mindfulness-based interventions in schools-a systematic review and meta-analysis. Front Psychol. 2014 Jun 30;5:603. doi: 10.3389/fpsyg.2014.00603. eCollection 2014.

ReferenceCitation: Hesse T, Holmes LG, Kennedy-Overfelt V, Kerr LM, Giles LL. Mindfulness-Based Intervention for Adolescents with Recurrent Headaches: A Pilot Feasibility Study. Evid Based Complement Alternat Med. 2015;2015:508958. doi: 10.1155/2015/508958. Epub 2015 Dec 22.

ReferenceCitation: Chadi N, McMahon A, Vadnais M, Malboeuf-Hurtubise C, Djemli A, Dobkin PL, Lacroix J, Luu TM, Haley N. Mindfulness-based Intervention for Female Adolescents with Chronic Pain: A Pilot Randomized Trial. J Can Acad Child Adolesc Psychiatry. 2016 Fall;25(3):159-168. Epub 2016 Nov 1.

ReferenceCitation: Ruskin D, Harris L, Stinson J, Kohut SA, Walker K, McCarthy E. "I Learned to Let Go of My Pain". The Effects of Mindfulness Meditation on Adolescents with Chronic Pain: An Analysis of Participants' Treatment Experience. Children (Basel). 2017 Dec 15;4(12). pii: E110. doi: 10.3390/children4120110.

ReferenceCitation: Ruskin DA, Gagnon MM, Kohut SA, Stinson JN, Walker KS. A Mindfulness Program Adapted for Adolescents With Chronic Pain: Feasibility, Acceptability, and Initial Outcomes. Clin J Pain. 2017 Nov;33(11):1019-1029. doi: 10.1097/AJP.0000000000000490.

lead_sponsor: University Hospital, Toulouse


title: Follow-up of Contact at Risk of Monkeypox Infection: a Prospective Cohort Study

acronym: MonkeyVax

summary:
Since one month (first case confirmed the 05/06/2022), some cases of non-imported were reported by Portuguese and British authorities then in several Europeans countries, the US and the Canada. The 05/19/2022, a first case of Monkeypox was confirmed in France. The 06/01/2022, "Santé Publique France" (SPF) declared 33 confirmed cases of Monkeypox without a direct interaction with people returning from endemic area. No deaths are currently recorded.

Currently, data on efficiency of modified vaccinia Ankara virus (MVA) used in post-exposure prophylaxis are few. The Centers for Disease Control and Prevention (CDC) consider that 2 doses of MVA vaccine used in post-exposure vaccination do not prevent totally the infection but consider that one rapid vaccination of high-risk contacts could reduce the severity of symptoms.

In order to clarify clinical impact and safety of PEV, it is proposed to set up a national cohort including contacts cases falling within the indications for vaccination, i.e. seen within 14 days of last contact.

The purpose of this study is to estimate the failure rate of a PEV by the VMA vaccine in Monkeypox contact case participants at risk after one dose.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Prevalence of COVID-19 in a French Dependent Care Facility for the Elderly and in a French Long-term Care Unit: Observational Study

acronym: SPEED-COVID

summary: The aim of this study is to evaluate the prevalence of COVID-19 among the residents and geriatric inpatients of the care facilities attached to the Centre Hospitalier Sud Essonne (a general hospital located in Ile-de-France, France), and the factors that are likely to influence this prevalence.

lead_sponsor: Centre Hospitalier Sud Essonne


title: Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes: Blood Loss, Myocardial Injury After Non Cardiac Surgery

acronym: HYPOTHERMIE

summary:
The primary objectives of the study are

to perform a survey on the clinical management of unintentional hypothermia during surgery in France.
to assess the impact of perioperative hypothermia on anemia and myocardial injury.

lead_sponsor: Société Française d'Anesthésie et de Réanimation

location_facility: Service d'Anesthésie-Réanimation Chirurgicale, Hôpital Cochin


title: Evaluation of the Risk Associated With Impulsivity and Other Neuropsychological Factors on Suicidal Relapse Within Hospital Emergencies

acronym: SUI-PREDICT

summary:
Suicidal behavior (SB) is a major public health problem in France, with over 10,000 suicides (6th in the EU28) and 220,000 suicide attempts (SA) per year. These data seem underestimated by 20%. A large percentage of men (6%) and women (9%) in France made at least one lifetime SA. In addition, SBs are common among young people and are the second leading cause of death among 15-44 year-olds. The interaction of multiple factors in SB complicates the creation of predictive models. These are currently imprecise and prevent the development of consensual recommendations for the management of suicidal patients.

Most suicide attempters are evaluated in the emergency room where it is imperative to identify people with a high risk of relapse. Risk assessment is generally based on the experience of the practitioner who uses psychometric scales as support for clinical decisions. This assessment could be improved and supplemented by other sources of information. Thus, we aim to develop a short and specific tool that combines:

Neurocognitive measures carried out using computer software on domains strongly associated with SB: impulsivity, affective dysregulation, alterations in decision-making (risky choices), selective attention and verbal fluency.
Clinical and psychological assessment including the most predictive items of future SA: life events (environment) and personality traits (vulnerability). Suicide attempters will be assessed for SB and suicidal ideation in the emergency department. These measures will be repeated during a 12-month follow-up. We will use the data obtained to provide a more accurate measure of risk.


title: Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care

acronym: UNICO

summary: Several Drugs used in routine care in oncology induce rare but often severe or fatal cardiovascular or metabolic side effects. This study will investigate, evaluate, report and treat the cardiovascular side effects of anticancer drugs, through a specific cardiovascular routine checkup and follow-up taking place in several Cardio-oncology programs throughout France. The different including centers will be: Assistance Publique - Hôpitaux de Paris (APHP.6: Pitié-Salpétrière, Saint Antoine and Tenon's hospitals, Paris, France).

ReferenceCitation: Salem JE, Allenbach Y, Vozy A, Brechot N, Johnson DB, Moslehi JJ, Kerneis M. Abatacept for Severe Immune Checkpoint Inhibitor-Associated Myocarditis. N Engl J Med. 2019 Jun 13;380(24):2377-2379. doi: 10.1056/NEJMc1901677.

ReferenceCitation: Dolladille C, Ederhy S, Allouche S, Dupas Q, Gervais R, Madelaine J, Sassier M, Plane AF, Comoz F, Cohen AA, Thuny FR, Cautela J, Alexandre J. Late cardiac adverse events in patients with cancer treated with immune checkpoint inhibitors. J Immunother Cancer. 2020 Jan;8(1). pii: e000261. doi: 10.1136/jitc-2019-000261.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

location_facility: AP-HP, Tenon Hospital, Department of Cardiology

location_facility: AP-HP, Saint-Antoine Hospital, Department of cardiology


acronym: COVIBOOST

title: Immunogenicity and Reactogenicity Following a 3rd Dose of COVID-19 mRNA Vaccine (Pfizer-BioNtech) and Two Adjuvanted Sub-unit Vaccines (SP/GSK) Administered as a Booster in Adults Who Received 2 Doses of Pfizer-BioNTech mRNA Vaccine as a Primary Vaccination: A Randomized, Single-blinded Multicenter Clinical Trial

location_facility: GH Broca-Cochin-Hôtel-Dieu CIC 1417 Cochin-Pasteur

summary:
The vaccination campaign in France began in early 2021 and was declared mandatory for all French people in July 2021. The efficacy of COVID-19 vaccines has since been widely demonstrated, as well as their safety, and now 60% of the adult population in France has received a first dose, most of them with Pfizer-BioNTech's mRNA vaccine.

However, despite the increasing coverage, new data highlight the need for a booster dose for the most vulnerable people, including patients with immune deficiency. This makes it likely that a booster dose will also be needed in the general population, especially among healthcare workers, due to the active circulation of new variants since the beginning of summer 2021 and evidence of reduced protection against them.

On the other hand, in addition to evaluating the potential benefit of a booster vaccination, it appears interesting to also evaluate a heterologous vaccination regimen, i.e. a booster with a different vaccine than the one used for the primary vaccination. Some studies have already evaluated a two-dose heterologous regimen and the results have shown stronger protection against SARS-CoV-2. In addition, this alternative could provide a real benefit in terms of accessibility, cost, and acceptability.

The vaccine developed by Sanofi-Pasteur is based on a traditional recombinant protein approach using GSK's AS03 adjuvant. Two formulations of this vaccine are currently under development, the first targeting the S protein of the D614 strain (Wuhan strain), the second targeting the B.1.351 variant. Their value as a booster needs to be evaluated.

The objective of this trial is therefore to evaluate the immunological response and safety induced by a homologous vaccine booster (Pfizer-BioNTech vaccine booster) and a heterologous vaccine booster (one of the two experimental Sanofi/GSK vaccines booster), on the D614 (Wuhan) strain and on the SARS-CoV-2 variants.


title: Kidney Transplant Outcome and Organ Acceptance Practice Pattern: A Nationwide Analyses in the US and France

acronym: USFRKT

summary:
Despite the considerable advances in short-term outcomes, kidney transplant recipients continue to suffer from late allograft failure, and little improvement has been made over the past 15 years. The worldwide scarcity of donated kidneys and the decline in the number of living donor transplants have prompted a variety of efforts to expand the organ supply, such as accepting organs from donors who were older or had comorbidities or other injuries.

Two major initiatives from the United Network for Organ Sharing (UNOS), the organization responsible for organ allocation in the US, failed to improve the kidney acceptance rate. First, UNOS introduced the Kidney Donor Risk Index (KDRI) for all kidney offers in 2012. The KDRI is a score that predicts survival of deceased donor kidneys based on 10 donor characteristics and was intended to simplify the process of judging organ quality for clinicians. Second, in 2014, UNOS changed the kidney allocation system so that lower-quality kidneys are offered over wider geographic areas. Despite the ongoing severe organ shortage and these allocation initiatives, the number of discarded kidneys rose from 2,127 (14.9%) in 2006 to 3,631 (20%) in 2016. In this context, the experience of transplant programs outside the US could offer novel approaches to making organ utilization more efficient through the examination of the disposition of organs that are usually discarded in the US.

This project aims:

To evaluate the potential benefit of transplanting kidneys that would have been discarded otherwise in the US
Computer simulation models on real life data to estimate the number of kidney transplants that would have taken place using data from a nationwide cohort study in two countries (France, the US);
To evaluate the potential gains in allograft survival years that would result in the US from a less restrictive kidney acceptance practice such as the one from France.

time_perspective: Other

ReferenceCitation: Aubert O, Reese PP, Audry B, Bouatou Y, Raynaud M, Viglietti D, Legendre C, Glotz D, Empana JP, Jouven X, Lefaucheur C, Jacquelinet C, Loupy A. Disparities in Acceptance of Deceased Donor Kidneys Between the United States and France and Estimated Effects of Increased US Acceptance. JAMA Intern Med. 2019 Oct 1;179(10):1365-1374. doi: 10.1001/jamainternmed.2019.2322.

lead_sponsor: Paris Translational Research Center for Organ Transplantation

location_country:
United States
France

location_facility: Kidney Transplantation Care at Veteran's Affairs Medical Center


title: Prognostic Impact of Immunohistochemical and Molecular Expression of the Endocytosis Receptor LRP1 in Colonic Adenocarcinomas

summary:
Colorectal cancer (CRC) is a major public health problem in France and worldwide. CRC is the third most common cancer in incidence and mortality in France. The vast majority of these cancers are adenocarcinomas that arise sporadically and develop from precursor lesions: adenoma. All CCR with the same disease stage do not have the same prognosis. Various parameters have been identified as factors influencing the prognosis and allows adjustment of the treatment. The poor histoprognostic factors are vessels and nerves invasion by the tumor or the mucinous adenocarcinoma subtype. At the molecular level, the presence of microsatellite instability (MSI) improves the prognosis, while the presence of a BRAF mutation is an independent poor prognostic factor.

LRP-1 is a multifunctional endocytic receptor that belongs to the family of LDL receptors. It is involved in the clearance of matrix proteases. A loss of expression or a decrease of the LRP-1 activity is correlated with an increase of aggressiveness of cancer cells. This effect was demonstrated in vitro in vesicular thyroid carcinomas after LRP-1 blocking. The decrease in the immunohistochemical expression and LRP-1 genomic in hepatocellular carcinomas and lung adenocarcinomas was correlated with a decrease in the overall survival. In CRC, only one immunohistochemical expression study of LRP-1 in colonic adenocarcinoma has been published to date. This study shows that tumor cells express LRP-1, but in nearly half the cases, weaker than in normal colonic cells. The clinical and prognostic impact of LRP-1 expression in colon cancer and its association with a particular molecular or morphological profile has not been studied to date.

In this work, the investigators will study the immunohistochemical and genic expression of LRP-1 in a series of colorectal cancers.

ReferenceCitation: Galissier T, Schneider C, Nasri S, Kanagaratnam L, Fichel C, Coquelet C, Diebold MD, Kianmanesh R, Bellon G, Dedieu S, Marchal Bressenot A, Boulagnon-Rombi C. Biobanking of Fresh-Frozen Human Adenocarcinomatous and Normal Colon Tissues: Which Parameters Influence RNA Quality? PLoS One. 2016 Apr 28;11(4):e0154326. doi: 10.1371/journal.pone.0154326. eCollection 2016.

lead_sponsor: CHU de Reims


title: IMproving Patient Adherence to Cervical Cancer Screening: a Randomized Trial Based on Reporting Women Who Did Not Perform a PAP Test Over the Last 3 Years to GP (IMPACT GP)

acronym: IMPACT GP

summary:
Context:

In France, cervical cancer (CC) screening was opportunistic until recently. The target population includes women aged 25 to 65 years. About 66% of women aged 25-40 years have performed a screening test over the last three years but this figure decreases to 55% in women over 40. The third "Cancer Plan" proposed by the French National Institute for Cancer recommends to achieve an 80% participation in eligible women.

Improving women compliance to CC screening is a major challenge to decrease cancer incidence and mortality.

To improve patient adherence, a CC screening organization will be launched in 2020 at a national scale in France. Women who did not perform a PAP test over the last 3 years will receive an invitation letter from the local public health association in charge of cancer screening organization. The invitation letter will remind women that they should consult a healthcare professional (a general practitioner (GP), a gynecologist or a midwife) to perform a screening test.

Providing GPs with a list of their non-adherent patients could also improve women compliance to CC screening recommendations.

The study objective is to assess whether sending both an invitation letter to non-adherent women and a list of their non-adherent patients to GPs ("invitation letter + GP reminder" group) could increase the proportion of women who perform a screening test, compared to only sending an invitation letter to non-adherent women ("invitation letter" group) or not sending any invitation ("usual care" group).

lead_sponsor: Nantes University Hospital


title: Comparison of Treatment of Atrial Fibrillation (AF) Between Surgical Ultrasonic Technology (EPICOR) or Drug Therapy (Cordarone) for Patients With AF Requiring Mitral Valve Surgery

acronym: EPICAF

summary:
In pre-operative cardiac surgery, 30 to 40% of patients with mitral valvulopathy have had episodes of paroxysmal atrial fibrillation (PAF) or are in permanent or chronic atrial fibrillation (CAF). According to the 1999 PMSI data, close to 4000 mitral valve interventions were performed in France, in other words, more than 1000 patients present with this condition annually; despite a surgical correction of their valvulopathy, patients presenting with a pre-operative chronic atrial fibrillation remain in fibrillation following surgery despite treatment with anti-arrhythmic agents associated or not with a cardioversion. Thus, the survival rate without AF recurrence is 10% at 1 year and 5% at 2 years in patients with AF prior to surgery; on the other hand, patients in sinus rhythm at the time of surgery and without an antecedent of AF exhibit an incidence of no AF of 90% and 74% at 1 and 2 years, respectively. It has also been shown in numerous studies that the long-term morbidity in patients with atrial valve surgery is higher in those with AF.

For more than 10 years, radio-frequency techniques using the endocavitary approach have shown a greater efficacy in maintaining sinus rhythm than drug therapy even though the techniques are invasive. These radio-frequency techniques were developed and tested during mitral surgery, but, to the investigators knowledge, there is only one randomized study that was carried out in a population with permanent AF using radio-frequency technique via the endocardial approach. Maintenance of sinus rhythm was obtained in only 44.4% of patients versus 4.5% in the control group; these results are not in accordance with the published prospective and retrospective registries using the technique peri-operatively. The principal problem of this study is the absence of medical treatment in the control group. In addition, the use of the radio-frequency technique requires an atriotomy resulting in a prolonged surgical time, which increases the peri-operative morbidity.

Other simpler ablation techniques have been developed, such as the one using ultrasound. In comparison with the radio-frequency method, this latter technique presents numerous advantages including the absence of an atriotomy due to the fact that the epicardial pathway is used, a short procedure time (11 min on average), excellent reproducibility, the transmural character of the lesions, along with the simplicity of application. There is not, to the investigators knowledge, a randomized study comparing the peri-operative ultrasound technique (EPICOR) in mitral valve surgery with the conservative reference treatment, notably mitral valve surgery coupled with long-term amiodarone treatment. In effect, while amiodarone is the most efficacious anti-arrhythmic agent in the long-term, this drug is associated with a high percentage of significant side effects, close to 20% at 2 years. The only available results using the ultrasound technique are the registries pertaining to the follow-up of patients undergoing cardiac mitral or aortic surgery, with an antecedent of AF. The results appear to be encouraging with 85% of cases maintained in sinus rhythm at 12 months in the most recent studies. In this clinical context, a French multi-centric registry evaluated the peri-operative treatment of AF with all of the proposed techniques (cryotherapy, radio-frequency, and ultrasound). The percentage of maintenance of sinus rhythm appears to be lower than in the historical registries, at the level of 60%, but the techniques used in this registry were multiple even if 50% of patients were treated with ultrasound; in addition, there was no randomization and follow-up was only for 6 months.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Hospices Civiles de Lyon
CHU de Grenoble
CHU de Saint-Etienne
CHU de Montpellier
CHU de Rennes