title: Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer of 70 Years Old Women : Contribution of Oncogeriatric Evaluation to the Study of Acute Toxicity

acronym: TOMOGYN

summary: Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years with a endometrial cancer.

location_facility:
Institut Jean Godinot
René Gauducheau Center
Bergonie Institut
François Baclesse Center
Paul Strauss Center
Centre Leon Berard
Oscar Lambret Center


type: Other Identifier

title: Intermediate-risk Prostate Cancer : Assessment of Hypofractionated Stereotactic Boost - Prospective Phase II Study

acronym: CKNO-PRO

summary: hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Pasquier D, Nickers P, Peiffert D, Maingon P, Pommier P, Lacornerie T, Martinage G, Tresch E, Lartigau E. Hypofractionated stereotactic boost in intermediate risk prostate carcinoma: Preliminary results of a multicenter phase II trial (CKNO-PRO). PLoS One. 2017 Nov 30;12(11):e0187794. doi: 10.1371/journal.pone.0187794. eCollection 2017.

ipd_sharing: No

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Alexis Vautrin
Centre Georges François Leclerc
Val d'Aurelle-Paul Lamarque
Centre Oscar LAMBRET
Centre Léon Bérard
Centre Paul Papin
Centre Hospitalier Lyon Sud

intervention_type: Radiation

lead_sponsor_type: industriel

status_simplified: Completed


title: Observatory on Different Artificial Labour-induction Methods and Measuring Immediate Postpartum Maternal Satisfaction

acronym: SATISFACC

summary:
Our hypothesis is that there is one sequence of labour-induction that leads to a better experience of childbirth than others. This is based on the following underlying theories :

Maternal satisfaction depends on the number of labour-inducing sequences
A longer labour-induction would be experienced less positively than a shorter one
The experience is correlated with maternal outcomes ( vaginal / Caesarian delivery, spontaneous birth or instrument-assisted birth, maternal complications ) and neonatal outcomes (neonatal complications, secondary hospitalization).

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU Arnaud de Villeneuve Service de Gynécologie Obstétrique

lead_sponsor_type: academique

status_simplified: Ongoing


title: Validation of an Accelerated Procedure of Selection in Early Liver Transplantation for Severe Alcoholic Hepatitis Not Responding to Medical Treatment QuickTransHAA.

acronym: QuickTrans

summary: The purpose of this study is to validate a strategy of identification of patients for early liver transplantation in severe alcoholic hepatitis. In this setting, short-term survival is very low (approx. 25% at 6 months) and a pilot study has suggested (mathurin et al. N Engl J Med 2011) that liver transplantation may be an option in very carefully selected patients who did not respond to medical treatment. This selection process deserves to be confirmed in a population of greater size. We hypothesized that patients selected with this process would have a same alcohol relapse rate after liver transplantation than patients transplanted for alcoholic cirrhosis and selected using a 6-month sobriety period

ReferenceCitation: Louvet A, Labreuche J, Moreno C, Vanlemmens C, Moirand R, Féray C, Dumortier J, Pageaux GP, Bureau C, Chermak F, Duvoux C, Thabut D, Leroy V, Carbonell N, Rolland B, Salamé E, Anty R, Gournay J, Delwaide J, Silvain C, Lucidi V, Lassailly G, Dharancy S, Nguyen-Khac E, Samuel D, Duhamel A, Mathurin P; QuickTrans trial study group. Early liver transplantation for severe alcohol-related hepatitis not responding to medical treatment: a prospective controlled study. Lancet Gastroenterol Hepatol. 2022 May;7(5):416-425. doi: 10.1016/S2468-1253(21)00430-1. Epub 2022 Feb 23.

lead_sponsor: University Hospital, Lille

location_country: France Belgium

location_facility: Hospital Antoine Béclère (Assistance Publique des Hôpiaux de Paris)

intervention_type: Procedure


title: Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura

acronym: APAM

summary: Recent data suggest involvement of Acid-Sensing Ion Channel channels in the pathophysiology of migraine making these channels a therapeutic target of migraine disease. The implication of Acid-Sensing Ion Channels is discussed through Acid-Sensing Ion Channel-1 which is the most expressed Acid-Sensing Ion Channel channel subtype in the central nervous system. In a mouse model, cortical spreading depression is inhibited by different Acid-Sensing Ion Channel blockers including amiloride which is a non-selective blocker of the Acid-Sensing Ion Channel-1 channel. From a translational perspective, an efficacy of amiloride on a series of migraine patients suffering from severe aura in open conditions. The APAM study is a proof-of-concept study that aims to evaluate the effect of amiloride in the prophylaxis of migraine with aura. This is a randomized crossover study versus placebo conducted in 3 French headache centers.

study_start_date_type: Anticipated

status: Unknown status

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Charles AC, Baca SM. Cortical spreading depression and migraine. Nat Rev Neurol. 2013 Nov;9(11):637-44. doi: 10.1038/nrneurol.2013.192. Epub 2013 Sep 17. Review.

ReferenceType: result

ReferenceCitation: Ayata C, Jin H, Kudo C, Dalkara T, Moskowitz MA. Suppression of cortical spreading depression in migraine prophylaxis. Ann Neurol. 2006 Apr;59(4):652-61.

ReferenceCitation: Ligthart L, Boomsma DI, Martin NG, Stubbe JH, Nyholt DR. Migraine with aura and migraine without aura are not distinct entities: further evidence from a large Dutch population study. Twin Res Hum Genet. 2006 Feb;9(1):54-63.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Montpellier
AP-HM

intervention_type: Drug

status_simplified: Unknown


title: International Prospective Study on Adherence to Treatment in Patients With Active Systemic Lupus Erythematosus

acronym: Adherence-SLE

summary:
The treatment of systemic lupus erythematosus (SLE) may change in the future due to the availability of new biological treatments, especially monoclonal antibodies in patients with active disease. However, one of the main causes of treatment failure in SLE is the lack of treatment adherence since "drugs don't work in patients who don't take them." Hydroxychloroquine (HCQ-Plaquenil) has a long terminal elimination half- life, and investigators have demonstrated that patients who do not take HCQ for a long time have undetectable or very-low blood HCQ concentrations (< 200 ng/ml). The rate of severe non-adherence was 7% in a cohort of 203 patients and was even higher in patients with active disease: 8 out of 35 (23%) in patients with a SLEDAI ≥6 and 6 out of 20 (30%) in patients with a SLEDAI ≥12.

Investigators will evaluate the importance of non-adherence to the treatment in a large population of SLE patients with active disease. This will be done with blood HCQ monitoring in a translational multicentric prospective study.

ReferenceCitation: Costedoat-Chalumeau N, Houssiau F, Izmirly P, Guern VL, Navarra S, Jolly M, Ruiz-Irastorza G, Baron G, Hachulla E, Agmon-Levin N, Shoenfeld Y, Dall'Ara F, Buyon J, Deligny C, Cervera R, Lazaro E, Bezanahary H, Leroux G, Morel N, Viallard JF, Pineau C, Galicier L, Vollenhoven RV, Tincani A, Nguyen H, Gondran G, Zahr N, Pouchot J, Piette JC, Petri M, Isenberg D. A Prospective International Study on Adherence to Treatment in 305 Patients With Flaring SLE: Assessment by Drug Levels and Self-Administered Questionnaires. Clin Pharmacol Ther. 2019 Aug;106(2):374-382. doi: 10.1002/cpt.1194. Epub 2018 Sep 2.

ReferenceCitation: Costedoat-Chalumeau N, Houssiau F, Izmirly P, Le Guern V, Navarra S, Jolly M, Ruiz-Irastorza G, Baron G, Hachulla E, Agmon-Levin N, Shoenfeld Y, Dall'Ara F, Buyon J, Deligny C, Cervera R, Lazaro E, Bezanahary H, Leroux G, Morel N, Viallard JF, Pineau C, Galicier L, Van Vollenhoven R, Tincani A, Nguyen H, Gondran G, Zahr N, Pouchot J, Piette JC, Petri M, Isenberg D. A Prospective International Study on Adherence to Treatment in 305 Patients With Flaring SLE: Assessment by Drug Levels and Self-Administered Questionnaires. Clin Pharmacol Ther. 2018 Jun;103(6):1074-1082. doi: 10.1002/cpt.885. Epub 2017 Nov 9. Corrected and republished in: Clin Pharmacol Ther. 2019 Aug;106(2):374-382.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Systematic Screening for Viral Hepatitis B and C at the PASS Consultation of the Montpellier University Hospital

acronym: dHEPass

summary:
A high number of people are infected by viral hepatitises B and C without knowing it, especially vulnerable population such as the ones who come in consultation in continuous health care access center (Permanence d'accès aux soins, PASS). Now that these infections can be rapidly treated, it is essential to diagnose them the quickest possible. The Identification and Diagnostic Orientation Test (Test de repérage et d'orientation diagnostique, TROD) technique is a rapid tool allowing to screen for hepatitis B and C by a simple capillary sample.

The study aims to evaluate the accptability of a systematic screening using TROD for hepatitis B and C in adults in a PASS consultation in Montpellier.

We also want to estimate the prevalence of theses infections in the population, to describe the HBV and HCV care cascades, to evaluate the acceptability of vaccinal catch-up for HBV, and to describe people with hepatits.

lead_sponsor: University Hospital, Montpellier


title: In Adults With Very Unstable Type 1 Diabetes, is the DBLHU Closed-Loop Insulin Delivery System Able to Improve Blood Glycemic Control Compared to Low-Glucose-Predictive-Suspend System: Two-center, Randomized, Open-label Study

acronym: DBLHU

summary:
Feasibility study, comparing experimental treatment (DBLHU closed-loop system) with reference treatment (Low Glucose Predictive Suspend system) in 7 patients going through a series of N-of-1 trials. Each N-of-1 trial consists in a prospectively planned, multiple crossover study in a single individual. Two blocks of two periods of four weeks each (closed loop or open loop) will be conducted. Within each block, the sequence closed loop-open loop or open loop-close loop is randomized. Outcomes will be analyzed on the third and fourth weeks of period.

A remote monitoring system managed by specialized nurse on behalf of diabetologist, is provided in closed-loop session.

An extension period of 48 weeks with the DBLHU System (closed-loop condition) will be performed at the end of the crossover study phase in real life conditions (without remote monitoring).

primary_purpose: Device Feasibility

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility:
Lille University Hospital
Grenoble Alpes University Hospital

intervention_type: Device


title: Validation of the Watch Withings HWA08 for the Detection of Atrial Fibrillation

acronym: MOVE-ECG

summary: The proposed clinical study aims at validating the diagnostic performance, in comparison with a reference ECG, of Withings HWA08 watch for the automatic identification of atrial fibrillation (AF).

primary_purpose: Diagnostic

lead_sponsor: Withings

location_facility:
Centre Cardiologique du Nord
Clinique AXIUM Centre de cardiologie

intervention_type: Diagnostic Test


title: Long Term Natural History of PTS and Other Adverse Outcomes After Venous Thromboembolism in the Optimev Study (SPOT)

acronym: SPOT

summary:
Post-thrombotic syndrome (PTS) is a frequent and burdensome complication of deep-vein thrombosis (DVT). In the absence of curative treatment of established PTS, its management is based on the prevention of its occurrence thanks to anticoagulants and compression stockings.

So far, predictors of disabling PTS are unknown precluding from optimally selecting patients for invasive (early thrombus removal) or innovative/expensive treatments. In addition, little is known on the incidence of PTS in the very long-term.

Objectives: To assess, 12 years after a symptomatic venous thromboembolic (VTE) event, Primary objective: incidence and severity of PTS after a lower limb DVT.

Main Secondary objectives:

Incidence and severity of PTS according to VTE initial presentation (isolated distal DVT, isolated proximal DVT, PE + DVT).
Incidence and risk factors of disabling PTS Methods: Very long-term follow-up (12 years) of patients recruited in the large, multicentre, prospective, observational OPTIMEV study for a suspicion of VTE confirmed or ruled out with objective tests (Clinical Trials NCT00670540).

All patients with a DVT, an isolated PE and a random selection of controls (VTE - patients without any history of VTE after the 3 years of follow-up) will first benefit from a phone-PTS assessment. Those patients presenting at least a mild venous insufficiency and a selection of controls will undergo a clinical follow-up visit with clinical and Compleat Ultra Sound (CUS) assessment of PTS/venous insufficiency and an assessment of quality of life.

Perspectives: Improving our knowledge of PTS' incidence and predictors and of the impact of usual treatment. Better selecting patients eligible for invasive/innovative/expensive preventative procedures.

ReferenceCitation: Galanaud JP, Sevestre MA, Genty C, Pernod G, Quere I, Bosson JL. Is it useful to also image the asymptomatic leg in patients with suspected deep vein thrombosis?: comment. J Thromb Haemost. 2015 Nov;13(11):2127-30. doi: 10.1111/jth.13123. Epub 2015 Sep 30.

ReferenceCitation: Galanaud JP, Arnoult AC, Sevestre MA, Genty C, Bonaldi M, Guyard A, Giordana P, Pichot O, Colonna M, Quéré I, Bosson JL; OPTIMEV-SFMV Investigators. Impact of anatomical location of lower limb venous thrombus on the risk of subsequent cancer. Thromb Haemost. 2014 Dec;112(6):1129-36. doi: 10.1160/TH14-04-0351. Epub 2014 Aug 7.

ReferenceCitation: Le Moigne E, Genty C, Meunier J, Arnoult AC, Righini M, Bressollette L, Bosson JL, Le Gal G; OPTIMEV Investigators. Validation of the LEFt score, a newly proposed diagnostic tool for deep vein thrombosis in pregnant women. Thromb Res. 2014 Sep;134(3):664-7. doi: 10.1016/j.thromres.2014.07.009. Epub 2014 Jul 17.

ReferenceCitation: Galanaud JP, Sevestre MA, Genty C, Kahn SR, Pernod G, Rolland C, Diard A, Dupas S, Jurus C, Diamand JM, Quere I, Bosson JL; OPTIMEV-SFMV investigators. Incidence and predictors of venous thromboembolism recurrence after a first isolated distal deep vein thrombosis. J Thromb Haemost. 2014 Apr;12(4):436-43. doi: 10.1111/jth.12512.

ReferenceCitation: Galanaud JP, Bosson JL, Genty C, Presles E, Cucherat M, Sevestre MA, Quere I, Decousus H, Leizorovicz A. Superficial vein thrombosis and recurrent venous thromboembolism: a pooled analysis of two observational studies. J Thromb Haemost. 2012 Jun;10(6):1004-11. doi: 10.1111/j.1538-7836.2012.04704.x.

ReferenceCitation: Maufus M, Bosson JL, Genty C, Delluc A, Imbert P, Gagne P, Rolland C, Bressollette L, Le Gal G. [Validation of a deep vein thrombosis prediction rule in primary care]. J Mal Vasc. 2012 Feb;37(1):9-14. doi: 10.1016/j.jmv.2011.10.005. Epub 2011 Dec 12. French.

ReferenceCitation: Galanaud JP, Genty C, Sevestre MA, Brisot D, Lausecker M, Gillet JL, Rolland C, Righini M, Leftheriotis G, Bosson JL, Quere I; OPTIMEV SFMV investigators. Predictive factors for concurrent deep-vein thrombosis and symptomatic venous thromboembolic recurrence in case of superficial venous thrombosis. The OPTIMEV study. Thromb Haemost. 2011 Jan;105(1):31-9. doi: 10.1160/TH10-06-0406. Epub 2010 Sep 30.

ReferenceCitation: Utne KK, Ghanima W, Foyn S, Kahn S, Sandset PM, Wik HS. Development and validation of a tool for patient reporting of symptoms and signs of the post-thrombotic syndrome. Thromb Haemost. 2016 Jan;115(2):361-367. doi: 10.1160/th15-04-0318. Epub 2015 Sep 17.

ReferenceCitation: Johnson SA, Stevens SM, Woller SC, Lake E, Donadini M, Cheng J, Labarère J, Douketis JD. Risk of deep vein thrombosis following a single negative whole-leg compression ultrasound: a systematic review and meta-analysis. JAMA. 2010 Feb 3;303(5):438-45. doi: 10.1001/jama.2010.43. Review.

ReferenceCitation: Galanaud JP, Sevestre MA, Genty C, Laroche JP, Zizka V, Quéré I, Bosson JL; OPTIMEV SFMV investigators. Comparison of the clinical history of symptomatic isolated muscular calf vein thrombosis versus deep calf vein thrombosis. J Vasc Surg. 2010 Oct;52(4):932-8, 938.e1-2. doi: 10.1016/j.jvs.2010.05.019. Epub 2010 Jul 13.

ReferenceCitation: Sevestre MA, Quashié C, Genty C, Rolland C, Quéré I, Bosson JL; Optimev study investigators. Clinical presentation and mortality in pulmonary embolism: the Optimev study. J Mal Vasc. 2010 Jul;35(4):242-9. doi: 10.1016/j.jmv.2010.05.004. Epub 2010 Jul 2.

ReferenceCitation: Sevestre MA, Labarère J, Casez P, Bressollette L, Haddouche M, Pernod G, Quéré I, Bosson JL. Outcomes for inpatients with normal findings on whole-leg ultrasonography: a prospective study. Am J Med. 2010 Feb;123(2):158-65. doi: 10.1016/j.amjmed.2009.05.034.

ReferenceCitation: Casez P, Labarère J, Sevestre MA, Haddouche M, Courtois X, Mercier S, Lewandowski E, Fauconnier J, François P, Bosson JL. ICD-10 hospital discharge diagnosis codes were sensitive for identifying pulmonary embolism but not deep vein thrombosis. J Clin Epidemiol. 2010 Jul;63(7):790-7. doi: 10.1016/j.jclinepi.2009.09.002. Epub 2009 Dec 2.

ReferenceCitation: Galanaud JP, Sevestre-Pietri MA, Bosson JL, Laroche JP, Righini M, Brisot D, Boge G, van Kien AK, Gattolliat O, Bettarel-Binon C, Gris JC, Genty C, Quere I; OPTIMEV-SFMV Investigators. Comparative study on risk factors and early outcome of symptomatic distal versus proximal deep vein thrombosis: results from the OPTIMEV study. Thromb Haemost. 2009 Sep;102(3):493-500. doi: 10.1160/TH09-01-0053.

ReferenceCitation: Sevestre MA, Labarère J, Casez P, Bressollette L, Taiar M, Pernod G, Quéré I, Bosson JL. Accuracy of complete compression ultrasound in ruling out suspected deep venous thrombosis in the ambulatory setting. A prospective cohort study. Thromb Haemost. 2009 Jul;102(1):166-72. doi: 10.1160/TH09-01-0048.

ReferenceCitation: Constans J, Salmi LR, Sevestre-Pietri MA, Perusat S, Nguon M, Degeilh M, Labarere J, Gattolliat O, Boulon C, Laroche JP, Le Roux P, Pichot O, Quéré I, Conri C, Bosson JL. A clinical prediction score for upper extremity deep venous thrombosis. Thromb Haemost. 2008 Jan;99(1):202-7. doi: 10.1160/TH07-08-0485.

ReferenceCitation: Sevestre MA, Labarere J, Brin S, Carpentier P, Constans J, Degeilh M, Deslandes B, Elgrishi I, Lanoye P, Laroche JP, Le Roux P, Pichot O, Quéré I, Bosson JL; OPTIMEV study. [Optimizing history taking for evaluating the risk of venous thromboembolism: the OPTIMEV study]. J Mal Vasc. 2005 Sep;30(4 Pt 1):217-27. French.

lead_sponsor: Association des Médecins Vasculaires Hospitaliers

intervention_type: Other


title: Analysis of Circulating Tumor Markers in Blood

acronym: ALCINA 2

summary: The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow the study of the mechanisms of resistance under process. In the multiplicity of these blood potential biomarkers joins a permanent evolution of the technological means used to detect them/to quantify, as well as to estimate their clinical utility.

ReferenceCitation: Leenhardt F, Alexandre M, Guiu S, Pouderoux S, Beaujouin M, Lossaint G, Philibert L, Evrard A, Jacot W. Impact of pharmacist consultation at clinical trial inclusion: an effective way to reduce drug-drug interactions with oral targeted therapy. Cancer Chemother Pharmacol. 2021 Oct;88(4):723-729. doi: 10.1007/s00280-021-04331-0. Epub 2021 Jul 20.

ReferenceCitation: Leenhardt F, Gracia M, Perrin C, Muracciole-Bich C, Marion B, Roques C, Alexandre M, Firmin N, Pouderoux S, Mbatchi L, Gongora C, Jacot W, Evrard A. Liquid chromatography-tandem mass spectrometric assay for the quantification of CDK4/6 inhibitors in human plasma in a clinical context of drug-drug interaction. J Pharm Biomed Anal. 2020 Sep 5;188:113438. doi: 10.1016/j.jpba.2020.113438. Epub 2020 Jun 22.

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

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

intervention_type: Biological


title: Phase III Study Evaluating the Efficacy of Topical Morphine in the Treatment of Severe Local Pain of Chronic Wounds

acronym: EMGEL

summary: This phase III study aims to show that topical morphine low doses treats localized pain in chronic wounds, intense and rebellious to systemic analgesics included or not opioids.

status: Terminated

lead_sponsor: Institut Curie

location_facility:
Institut Curie - Hôpital René Huguenin
Groupe Hospitalier Bichat
Hôpital Jean-Jaurès
Hôpital Louis Mourier
Institut Curie


title: Evaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy

acronym: HABIT-ILE

summary:
An urgent priority in the field of paediatric neurorehabilitation is the development of effective early motor interventions.

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (= HABIT-ILE) applies the concepts of motor skill learning and intensive training to both the Upper Extremities (UE) and Lower Extremities (LE) and has been shown to improve aspects of motor function of the UE and LE in school age children with unilateral and bilateral Cerebral Palsy (CP) across the 3 levels of the International Classification of Functioning, Disability and Health (ICFDH). The principles and content of HABIT-ILE can be applied to pre-school children and this method is highly promising for early rehabilitation.

primary_purpose: Supportive Care

ReferenceCitation: Araneda R, Sizonenko SV, Newman CJ, Dinomais M, Le Gal G, Ebner-Karestinos D, Paradis J, Klöcker A, Saussez G, Demas J, Bailly R, Bouvier S, Nowak E, Guzzetta A, Riquelme I, Brochard S, Bleyenheuft Y. Protocol of changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with bilateral cerebral palsy: a multisite randomized controlled trial. BMC Neurol. 2020 Jun 12;20(1):243. doi: 10.1186/s12883-020-01820-2.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
Fondation ILDYS - Site de Ty Yann
Les Capucins


title: Effectiveness of the First French Psychoeducational Program for Suicidal Behavior : a Randomized Controlled Trial

acronym: PEPSUI

summary:
The aims of the recent World Health Organization report, highlighting that every 40 seconds a person dies from suicide somewhere in the world, are to increase awareness on the public health significance of suicide and make suicide prevention a greater priority within the global public health agenda. Across age groups, less than half of individuals at elevated suicide risk interface with some form of mental health services. Several barriers to help-seeking have been identified (maladaptive coping, lack of perceived need, beliefs about treatment effectiveness, fear of hospitalization or mistrust of providers, stigma...), which are key targets in knowledge-based interventions on suicide. Psychoeducational programs have shown effectiveness in prevention relapse for several mental disorders such as schizophrenia, bipolar disorder or recurrent depressive disorder, improving treatment adherence and self-confidence in coping with symptoms of the disease. They are highly recommended for addressing adherence problems in patients with serious and persistent mental illness. Only one team has published a study protocol for a controlled trial assessing a 10 group sessions psychoeducational program for prevention in patients having a suicide history, in a one-year follow-up. Interestingly, diagnosis-mixed group psychoeducation have shown superiority than an unspecific intervention add-on routine care, on the suicide prevention and compliance for severe psychiatric disorders. Those psychoeducational-specific elements are namely the interactive transfer of illness and treatment-related knowledge and management/coping - cognitive/behavioral - strategies, as defined by the National Institute for Health and Care Excellence)-Guidelines (NICE). Notably, as several psychiatric diagnoses are associated with suicidal behavior (SB), coping strategies have to target processes that overlap among these psychiatric disease, as well as suicidal vulnerability. Acceptance and Commitment Therapy (ACT), a "third wave" behavioral therapy, targets experiential avoidance and psychological flexibility, at the core of psychiatric disorders. Interestingly, in patients with a history of suicidal depression, training in mindfulness can help to weaken suicidal thinking associated with depressive symptoms , and thus reduce an important vulnerability for relapse to suicidal depression. ACT would also increase intrinsic motivation for daily life action (i.e. reasons for living and acting). Then, the functional analysis (matrix) used in ACT seems to be an useful tool to help patient in decision making, a neuropsychological factor impaired in suicidal patients. Finally, acceptance and commitment group therapy has suggested effectiveness in reducing intensity and frequency of suicidal thoughts, through improvement in acceptance, in high risk suicidal patients. As compared with ACT, Dialectical behavior therapy (DBT) teaches added distress tolerance in view of survive the crisis. DBT is the most validated therapy for borderline personality disorder, the mental disorder the most associated with SB . Notably, group skills training is the most effective component in DBT for preventing suicidal behavior in borderline patients with high suicidal risk. Furthermore, interventions based on positive psychology have suggested efficacy in reducing depressive symptoms and suicidal ideation. Notably, in a recent pilot study, positive psychology exercises delivered to suicidal inpatients were feasible and associated with short-term gains improvement in optimism and hopelessness. Finally, as altered social link and sense of belonging have been widely involved in SB, relationship skills are an interesting positive psychology area for suicide prevention program.

Psychoeducational program integrating knowledge as well the last innovating cognitive-behavioral coping strategies for SB is of major interest in suicide prevention.

Investigators developed the first French program of suicide psychoeducation called "PEPSUI". The aim of this innovating program is to teach patients the more recent knowledge about suicidal behaviour (SB) and effective treatments, through didactic and interactive sessions. Thus, the objective is to conduct the patients to become experts and actors of their disease, increasing adherence to treatment. Besides, the patients will experiment the last innovating psychological skills to cope with unpleasant emotions and thoughts (including suicidal thoughts), distress tolerance skills and crisis strategies, and identify personal purpose in life and learn positive psychological skills in order to anchor with meaningful and pleasant components in life. Thus, this program will include skills from ACT, DBT and positive psychology. Finally, this primary care research is about a program which aim at improving accessibility to mental health services, care adherence and continuity for suicidal patients.

primary_purpose: Prevention

ReferenceCitation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013668. doi: 10.1002/14651858.CD013668.pub2.

ReferenceCitation: Storebø OJ, Stoffers-Winterling JM, Völlm BA, Kongerslev MT, Mattivi JT, Jørgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5:CD012955. doi: 10.1002/14651858.CD012955.pub2.


title: Rapid Oral Treatment of Cluster Epileptic Seizures. Efficacy Assessment of Levetiracetam in Cluster Seizures.

summary:
This is a double blind, placebo controlled, add-on clinical trial, of levetiracetam efficacy and safety, in epilepsy cluster seizure.

Efficacy is evaluated in the range of 2 to 24 hours after taking the tablet. If the patient has a seizure during this interval, he is considered as a non-respondent patient.

ReferenceCitation: Haut SR, Shinnar S, Moshé SL. Seizure clustering: risks and outcomes. Epilepsia. 2005 Jan;46(1):146-9.

ReferenceCitation: Dreifuss FE, Rosman NP, Cloyd JC, Pellock JM, Kuzniecky RI, Lo WD, Matsuo F, Sharp GB, Conry JA, Bergen DC, Bell WE. A comparison of rectal diazepam gel and placebo for acute repetitive seizures. N Engl J Med. 1998 Jun 25;338(26):1869-75.

ReferenceCitation: Mitchell WG, Conry JA, Crumrine PK, Kriel RL, Cereghino JJ, Groves L, Rosenfeld WE. An open-label study of repeated use of diazepam rectal gel (Diastat) for episodes of acute breakthrough seizures and clusters: safety, efficacy, and tolerance. North American Diastat Group. Epilepsia. 1999 Nov;40(11):1610-7.

ReferenceCitation: Shorvon SD, Löwenthal A, Janz D, Bielen E, Loiseau P. Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in patients with refractory partial seizures. European Levetiracetam Study Group. Epilepsia. 2000 Sep;41(9):1179-86.

ReferenceCitation: Cereghino JJ, Biton V, Abou-Khalil B, Dreifuss F, Gauer LJ, Leppik I. Levetiracetam for partial seizures: results of a double-blind, randomized clinical trial. Neurology. 2000 Jul 25;55(2):236-42.

lead_sponsor: University Hospital, Grenoble

location_facility:
Neurology Department
Neurology department
Etablissement la Teppe


title: Evaluation of the Interest of PET/CT at 18F-FDG in the Post-therapeutic Management of Cervical Cancer at an Advanced Stage. Multicenter Prospective Observational Study

acronym: COLTEP

summary:
A lot of studies have demonstrated the prognostic value of post therapy 18F-FDG PET/CT in the management of uterine cervical cancer. Post therapy 18F-FDG PET/CT is usually requested by a lot of clinicians.

Whereas 18F-FDG PET/CT is useful for prognosis in the follow-up, data are yet insufficient to clearly establish a formal recommendation.

This prospective multicenter observational study will evaluate the interest of post therapy 18F-FDG PET/CT in clinical management (within 2 months of treatment) in patients with cervical cancer at an advanced stage.

Main outcome :

The therapeutic impact of post therapy 18F-FDG PET/CT (within 2 months after the end of therapy) will be evaluated on the complete results included MRI.

Investigators will compare :

decision of clinicians without 18F-FDG PET/CT results
and decision of clinicians knowing entire results included results of 18F-FDG PET/CT.

location_facility:
CHRU de Brest (Hôpital Morvan)
Centre Henri Becquerel


title: Adrenomedullin and Outcome in Severe Sepsis and Septic Shock. The AdrenOSS Study.

acronym: AdrenOSS

summary: The aim of this prospective study is to assess the prognostic value of bioactive plasma adrenomedullin (ADM) in 600 patients with severe sepsis or septic shock in an international multicenter study and to validate the findings concerning the association of ADM concentration and the use of vasopressor therapy, organ failure and outcome.

ReferenceCitation: Jolly L, Carrasco K, Salcedo-Magguilli M, Garaud JJ, Lambden S, van der Poll T, Mebazaa A, Laterre PF, Gibot S, Boufenzer A, Derive M. sTREM-1 is a specific biomarker of TREM-1 pathway activation. Cell Mol Immunol. 2021 Aug;18(8):2054-2056. doi: 10.1038/s41423-021-00733-5. Epub 2021 Jul 19.

ReferenceCitation: Blet A, Deniau B, Santos K, van Lier DPT, Azibani F, Wittebole X, Chousterman BG, Gayat E, Hartmann O, Struck J, Bergmann A, Antonelli M, Beishuizen A, Constantin JM, Damoisel C, Deye N, Di Somma S, Dugernier T, François B, Gaudry S, Huberlant V, Lascarrou JB, Marx G, Mercier E, Oueslati H, Pickkers P, Sonneville R, Legrand M, Laterre PF, Mebazaa A; AdrenOSS-1 Study Investigators. Monitoring circulating dipeptidyl peptidase 3 (DPP3) predicts improvement of organ failure and survival in sepsis: a prospective observational multinational study. Crit Care. 2021 Feb 15;25(1):61. doi: 10.1186/s13054-021-03471-2.

ReferenceCitation: Mebazaa A, Geven C, Hollinger A, Wittebole X, Chousterman BG, Blet A, Gayat E, Hartmann O, Scigalla P, Struck J, Bergmann A, Antonelli M, Beishuizen A, Constantin JM, Damoisel C, Deye N, Di Somma S, Dugernier T, François B, Gaudry S, Huberlant V, Lascarrou JB, Marx G, Mercier E, Oueslati H, Pickkers P, Sonneville R, Legrand M, Laterre PF; AdrenOSS-1 study investigators. Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock-1 (AdrenOSS-1) study. Crit Care. 2018 Dec 21;22(1):354. doi: 10.1186/s13054-018-2243-2.

ReferenceCitation: Hollinger A, Wittebole X, François B, Pickkers P, Antonelli M, Gayat E, Chousterman BG, Lascarrou JB, Dugernier T, Di Somma S, Struck J, Bergmann A, Beishuizen A, Constantin JM, Damoisel C, Deye N, Gaudry S, Huberlant V, Marx G, Mercier E, Oueslati H, Hartmann O, Sonneville R, Laterre PF, Mebazaa A, Legrand M. Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Kidney in Sepsis and Septic Shock (Kid-SSS) Study. Kidney Int Rep. 2018 Aug 22;3(6):1424-1433. doi: 10.1016/j.ekir.2018.08.006. eCollection 2018 Nov. Erratum in: Kidney Int Rep. 2018 Nov 17;4(1):187.

lead_sponsor: Sphingotec GmbH

location_country: Italy Netherlands France Belgium Germany

location_facility: Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Köln

location_facility: UMC Radboudziekenhuis, Dept. Intensive Care

location_facility: Klinik für Anästhesie, Intensivmedizin und Schmerztherapie, HELIOS-Klinikum Erfurt,

location_facility: Medisch Spectrum Twente; Departement of Intensive Care

location_facility: Klinik für Operative Intensivmedizin und Intermediate Care


title: Impact of Sophrology on Exercise Capacity of Adolescents and Young Adults With Congenital Heart Disease : Multicenter Randomized Controlled Trial

acronym: SOPHRO CARE

summary:
The SOPHRO-CARE trial aims to measure the impact of sophrology on exercise capacity of adolescents and young adults with congenital heart disease.

Investigator hypothesized that a series of group sessions of sophrology may improve the exercise capacity, in this population.

ReferenceCitation: Moreau J, Lavastre K, Romieu H, Charbonnier F, Guillaumont S, Bredy C, Abassi H, Werner O, De La Villeon G, Requirand A, Auer A, Matecki S, Karsenty C, Guitarte A, Hadeed K, Dulac Y, Souletie N, Acar P, Bajolle F, Bonnet D, Negre-Pages L, Mura T, Mounier M, Seguela PE, Thomas J, Iriart X, Jean-Benoit-Thambo, Amedro P. Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods. Int J Cardiol Heart Vasc. 2020 Mar 3;27:100489. doi: 10.1016/j.ijcha.2020.100489. eCollection 2020 Apr.

location_facility:
CHU de Montpellier
Institut Saint-Pierre


title: Head-up Position, Active Compression-decompression Mechanical Cardiopulmonary Resuscitation and Impedance Threshold Device to Improve Outcomes in Out-of-hospital Cardiac Arrest. A Multicenter Prospective Controlled Quasi-experimental Trial

acronym: GRAVITY

summary:
Elevation of the head and thorax, also known as Head-up cardiopulmonary resuscitation (HUP CPR), has been studied extensively in pigs in ventricular fibrillation (VF). HUP combined with active compression decompression and impedance threshold device (ACD+ITD) CPR improves vital organ perfusion and results in a doubling of cerebral perfusion when compared with the same method of CPR in the flat or horizontal plane. HUP CPR enhances the drainage of venous blood from the brain, lowers central venous pressures, reduces intracranial pressures during the decompression phase of CPR, redistributes blood flow through the lungs during CPR, and may reduce brain edema. These mechanisms collectively contribute to improved blood flow and less injury to the brain during CPR. These benefits are due in large part to the effects of gravity on the physiology of HUP CPR. Importantly, HUP CPR is dependent upon a means of generating enough forward flow to adequately pump blood "uphill" to the brain.

In this proposed pilot study, CPR will be performed manually before the patient is placed on a controlled mechanical elevation device (Elegard, Minnesota Resuscitation Solutions LLC, USA). An ITD-16 (ResQPOD-16, Zoll, USA) will be placed on the patient's airway before the head is elevated. Automated CPR will be initiated as soon as feasible using a new automated CPR mechanical compression device that provides full active compression-decompression CPR (LUCAS-AD, Stryker, USA).

The proposed feasibility clinical study will be the first ever to test the fully integrated system of ACD+ITD HUP CPR.

primary_purpose: Other

ipd_sharing_description: Study protocol will be submitted for publication. IPD will be shared with other researcher

location_facility:
SAMU 54 - CHU Nancy
SAMU 38


title: InterMob: a Randomized Controlled Trial Aimed at Reducing Car Use in Regular Car Users by Combining Hard and Soft Levers

acronym: InterMob

summary:
Regular car use is a source of pollution and physical inactivity. InterMob is an interdisciplinary randomized controlled behavioral intervention aiming at reducing car use. The objectives of InterMob are to a) Evaluate the efficacy of a theory- and evidence-based intervention, b) Identify the mechanisms related mobility change, and c) Identify the conditions under which the intervention is effective.

To meet these objectives, 300 regular car users living in Grenoble will be recruited and randomized in one of two arms:

experimental group that will receive the InterMob intervention: six months of free public transport/access to a bicycle, and behavior change techniques (personalized transport advice, setting of mobility change goals, considering possible obstacles; 6 months of motivational messages to prompt goal setting and self-monitoring).
active control group that will receive information about air pollution (discussion about the health consequences of air pollution, the association between air pollution and car use; 6 months of messages to prompt air pollution monitoring.) Follow-up measures will be carried out until 24 months after the beginning of the study (8-day measurement sessions). Five sessions will involve wearing a GPS/accelerometer, and an air pollution sensor. Participants will complete mobility logs and questionnaires measuring the psychological mechanisms related to their mobility (habits, intentions, self-efficacy), and socio-economical characteristics (number of children, accessibility) during the 8 sessions.

The investigators hypothesize that the participants allocated to experimental group will reduce the car use and increase the use of alternative modes to the car (biking, walking, public transport, and carpooling) more than the participants of the control group, and that these changes will remain. The investigators hypothesize that mobility changes will be mediated by intention and self-efficacy. The investigators hypothesize that the efficacy of the intervention will be moderated by socio-spatial factors (number of children, travel distances) and psychological factors (self-control).

The main criterion will be car use reduction and the use of alternative modes to the car. In addition, the investigators will assess physical activity (minutes of moderate-to-vigorous physical activity), the exposure to air pollution, the quality of life and the carbon footprint associated to transport.

status: Enrolling by invitation

ReferenceCitation: Teran-Escobar C, Duché S, Bouscasse H, Isoard-Gatheur S, Juen P, Lacoste L, Lyon-Caen S, Mathy S, Ployon E, Risch A, Sarrazin P, Slama R, Tabaka K, Treibich C, Chardonnel S, Chalabaev A. InterMob: a 24-month randomised controlled trial comparing the effectiveness of an intervention including behavioural change techniques and free transport versus an intervention including air pollution awareness-raising on car use reduction among regular car users living in Grenoble, France. BMC Public Health. 2022 Sep 16;22(1):1763. doi: 10.1186/s12889-022-14099-4.

ipd_sharing_description: Data dictionary, statistical analysis plan, informed consent form, analytic code will be shared.

lead_sponsor: Aina Chalabaev


title: Monocytic Expression of HLA-DR After Liver Transplantation

acronym: EdMonHG

summary:
A defect of the immune response has been described in patients with severe liver disease. This immune-paresis is partly driven by a compensatory anti-inflammatory response following a systemic inflammatory response syndrome and affects the innate immune response. The innate immune defect has been described in patients with advanced cirrhosis and more significantly in patients with acute liver failure or acute on chronic liver failure (ACLF). The monocytes/macrophages pro-inflammatory response and finally the antimicrobial response are thus strongly impaired, leading to higher sepsis risk. The monocytes/macrophages phenotype associated with these functional alterations has been widely described, with a weaker expression of Human Leukocyte Antigen - DR isotype (HLA-DR) on the monocytes surface, correlated with poor outcomes. The low monocytic expression of HLA-DR, its functional and clinical impact has been widely described in the context of septic shock with similar pathophysiological mechanisms.

Liver transplantation (LT) is often the only therapeutic option for patients with advanced liver failure. Post-transplant survival of the most severe patients is similar to the survival in the whole population of LT patients, but the complication rate remains higher, with a major risk of infection. Currently used immunosuppression protocols do not take into account the quality of pre-transplant immune response. Some treatments, such as corticosteroids, which are widely used for the induction of post-transplant immunosuppression, may affect the innate immune response. However, it has been shown that low expression of post-transplant monocyte HLA-DR was associated with a greater risk of septic complication.

The general objective of this study is to focus on the evolution of a robust marker of immune dysfunction, HLA-DR monocyte expression, before and following LT, and to analyse its post LT expression depending on the level of pre-transplant expression as well as its association with post-transplant complications. This study will bring new insights for the design of a prospective study on the relevance of adapting post-transplant immunosuppression protocols to HLA-DR expression on monocytes surface, which is a robust marker of the innate immune response.

Evaluation of innate immune dysfunction pre-LT by quantification of monocytic HLA-DR expression and monitoring of its post-LT kinetics may be relevant for assessing post-transplant immune status and adapting immunosuppressive therapy. A descriptive, observational study associating clinical and biological data is needed to confirm the relevance of HLA-DR expression quantification on the surface of monocytes in a population of selected patients, before and after LT. These data will allow setting up a prospective interventional study reporting the possible benefit of post-transplant immunosuppressive treatment modulation, according to the HLA-DR monocyte dosage and its kinetics evolution.

The main objective of this study is to describe the association between evolution of monocytic HLA-DR expression on monocytes/macrophages surface during the first month after LT and the occurrence of one of the 2 following clinical events reflecting a post LT immune dysfunction (acute cell rejection and sepsis).

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'hépato gastroentérologie hôpital Edouard Herriot Groupement hospitalier centre


title: Determinants of Frailty Among of Informal Caregivers of Demented Patient Evaluated in Day Care Hospital.

acronym: DELFAF

summary: Frailty, a transitional state between successful and pathological aging, may be benefit from early multi-interventional intervention. Fried's criteria are the more commonly used criteria to diagnose frailty. The caregivers' burden increases caregivers' morbidity .The main objective of the study was to assess the relationship between frailty among informal caregivers of demented patients and the caregiver's burden (Zarit scale). The Secondary objective was to assess determinants of frailty among caregivers.

lead_sponsor: Gérond'if

location_facility:
Paul Brousse Hospital
Broca Hospital


title: Prediction of Clinical Course in COVID19 Patients Using Unsupervised Classification Approaches of Clinical, Biological and the Multiparametric Signature of the Chest CT Scan Performed at Admission

acronym: COVID-CTPRED

summary:
In the context of the COVID19 pandemic and containment, chest CT is currently frequently performed on admission, looking for suggestive signs and basic abnormalities of COVID19 compatible viral pneumonitis pending confirmation of identification of viral RNA by reverse-transcription polymerase chain reaction(PCR), with a reported sensitivity of 56-88% in the first few days, slightly higher than PCR (60%) (1). Nevertheless, currently established radiological abnormalities are not specific for COVID19 and the specificity of the chest CT is ~25% when PCR is used as a reference (1). Deconfinement and its consequences will complicate the triage of COVID patients and the role of the scanner, with the expected impact of a decrease in the prevalence of infection in the emergency department and an increase in the number of "all-round" patients, including patients with non-COVID viral infiltrates or pneumopathies.

In addition, there are currently no imaging criteria to complement the clinical and biological data that can predict the progression of lung disease from the initial data.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Identification of Biomarkers Related to Liver Fibrosis as New Therapeutic Targets

acronym: FIBROTHER

summary: Fibrosis is a dynamic process resulting from the balance of fibrogenesis and fibrolysis, mainly secondary to chronic necro-inflammation related to regular alcohol consumption, metabolic syndrome (NASH) or viral hepatitis. The liver has the property of allowing the reversion of fibrosis / cirrhosis when the necrotic-inflammatory activity is controlled. The balance between fibrosis / fibrolysis and its inhibition depends on many pathways and the hypothesis of the efficacy of a single treatment remains uncertain. Molecular factors in the progression of liver fibrosis should be determined. It is necessary to control the liver fibrosis and thus reduce the risk of carcinoma in this population. The anti-fibrotic drugs are being developed, but so far only alpha-tocopherol and obeticholic acid have been shown to have a significant anti-fibrotic effect in humans. Several new drugs are currently being evaluated in ongoing Phase 2 and 3 randomized clinical trials, but most of them have intrinsic limitations: (i) they take a long time for evaluation (> 3 years), ( ii) they generally require an histopathological evaluation by serial liver biopsies that are invasive and unpopular with patients who are aware of noninvasive tests for fibrosis assessment and (iii) treatment is often a single treatment versus a placebo group with the uncertainty that at 1 or 3 years, serial liver biopsies results are convincing.

lead_sponsor: Institut Pasteur

location_facility:
Cochin Hospital
Pitie-Salpetriere Hospital


title: Performance and Safety of the Resorbable Collagen Membrane "Ez Cure" in Guided Tissue Regeneration and Guided Bone Regeneration Procedures

summary:
The evaluation of the clinical data has demonstrated the conformity of the Resorbable Collagen Membrane (RCM), EZ CureTM, with the relevant essential requirements for its use in periodontal applications. The RCM is intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) procedures. It acts as a barrier against the migration of epithelial cells within the bone defect (performance) and thus complies with several surgical indications in the treatment of maxillofacial bone defects. It has been concluded that the risks associated with the use of this device are acceptable when weighted against the benefits to the patients.

In order to improve the clinical data on the RCM, the manufacturer, Biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. In this objective, the goal of this study will be to observe the following parameters:

Tissue regeneration (mucosa health on the site of implantation)
Safety (report of any adverse event)
Radiographic analysis of periodontal tissues

lead_sponsor: Biomatlante

location_facility: Centre de soins dentaires - Centre Hospitalo-Universitaire de Nantes


ipd_sharing: Undecided

acronym: TRACES

title: Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery: a Multicenter Randomized Double Blind Placebo Controlled Therapeutic and Pharmaco-biological Dose Ranging Study (TRACES) for Its Optimal Benefit/Risk

lead_sponsor: University Hospital, Lille

type: EudraCT Number

source: euctr

ReferenceCitation: van Geffen M, Loof A, Lap P, Boezeman J, Laros-van Gorkom BA, Brons P, Verbruggen B, van Kraaij M, van Heerde WL. A novel hemostasis assay for the simultaneous measurement of coagulation and fibrinolysis. Hematology. 2011 Nov;16(6):327-36. doi: 10.1179/102453311X13085644680348.

ReferenceCitation: Ducloy-Bouthors AS, Jude B, Duhamel A, Broisin F, Huissoud C, Keita-Meyer H, Mandelbrot L, Tillouche N, Fontaine S, Le Goueff F, Depret-Mosser S, Vallet B; EXADELI Study Group, Susen S. High-dose tranexamic acid reduces blood loss in postpartum haemorrhage. Crit Care. 2011;15(2):R117. doi: 10.1186/cc10143. Epub 2011 Apr 15.

ReferenceCitation: Anne-Sophie Ducloy-Bouthors, Alain Duhamel, Antoine Tournoys, Annabelle, Gisele Debize, Edith Peneau, Brigitte Jude, Benoit Vallet, Dominique De Prost, Cyril Huissoud, Sophie Susen., Hyperfibrinolysis and post-partum haemorrhage induced coagulopathy. 2013, Thrombosis research Volume 131, Supplement S88-89. Accepted BJA-2014-00923.

ReferenceCitation: Goobie SM, Meier PM, Sethna NF, Soriano SG, Zurakowski D, Samant S, Pereira LM. Population pharmacokinetics of tranexamic acid in paediatric patients undergoing craniosynostosis surgery. Clin Pharmacokinet. 2013 Apr;52(4):267-76. doi: 10.1007/s40262-013-0033-1.

ReferenceCitation: Rozen L, Faraoni D, Sanchez Torres C, Willems A, Noubouossie DC, Barglazan D, Van der Linden P, Demulder A. Effective tranexamic acid concentration for 95% inhibition of tissue-type plasminogen activator induced hyperfibrinolysis in children with congenital heart disease: A prospective, controlled, in-vitro study. Eur J Anaesthesiol. 2015 Dec;32(12):844-50. doi: 10.1097/EJA.0000000000000316.

ReferenceCitation: Ducloy-Bouthors AS, Gilliot S, Kyheng M, Faraoni D, Turbelin A, Keita-Meyer H, Rigouzzo A, Moyanotidou G, Constant B, Broisin F, Gouez AL, Favier R, Peynaud E, Ghesquiere L, Lebuffe G, Duhamel A, Allorge D, Susen S, Hennart B, Jeanpierre E, Odou P; TRACES working group. Tranexamic acid dose-response relationship for antifibrinolysis in postpartum haemorrhage during Caesarean delivery: TRACES, a double-blind, placebo-controlled, multicentre, dose-ranging biomarker study. Br J Anaesth. 2022 Oct 12. pii: S0007-0912(22)00504-9. doi: 10.1016/j.bja.2022.08.033. [Epub ahead of print]

ReferenceCitation: Ducloy-Bouthors AS, Jeanpierre E, Saidi I, Baptiste AS, Simon E, Lannoy D, Duhamel A, Allorge D, Susen S, Hennart B. TRAnexamic acid in hemorrhagic CESarean section (TRACES) randomized placebo controlled dose-ranging pharmacobiological ancillary trial: study protocol for a randomized controlled trial. Trials. 2018 Mar 1;19(1):149. doi: 10.1186/s13063-017-2421-6.

ReferenceCitation: Bouthors AS, Hennart B, Jeanpierre E, Baptiste AS, Saidi I, Simon E, Lannoy D, Duhamel A, Allorge D, Susen S. Therapeutic and pharmaco-biological, dose-ranging multicentre trial to determine the optimal dose of TRAnexamic acid to reduce blood loss in haemorrhagic CESarean delivery (TRACES): study protocol for a randomised, double-blind, placebo-controlled trial. Trials. 2018 Mar 1;19(1):148. doi: 10.1186/s13063-017-2420-7.

location_facility: Hospices civils de Lyon CHU-Lyon Croix Rousse

location_facility: Assistance Publique Hôpitaux Paris Hôpital Louis Mourier

location_facility: Centre Hospitalier Maternité Monaco Valenciennes

location_facility: Hôpital Jeanne de Flandre - CHRU de Lille

location_facility: Assistance Publique Hôpitaux Paris Hôpital Trousseau

summary: TRACES trial is a multicenter randomized double blind placebo control therapeutic and pharmaco-biological dose ranging study to measure the effect on blood loss reduction of a single intravenous infusion of two doses regimens (standard dose and low dose) of TA administered at the onset of an active PPH (>800mL) during elective or non-emergent CS and to correlate this clinical effect with the biological effect of fibrinolysis inhibition and the pharmacodynamic measure of TA uterine bleeding and venous blood concentration.


title: Randomized Placebo-controlled Trial Comparing Methotrexate vs. Methotrexate/Metformin Association in Rheumatoid Arthritis Patients

summary: Methotrexate (MTX) is the anchor drug for patients with rheumatoid arthritis (RA). Despite its marked efficacy and acceptable side effect profile, about 1/3 of patients failed to reach RA remission. Metformin is the first-line therapy for type 2 diabetes. Its antioxidative and anti-inflammatory properties make it a good candidate for the treatment of inflammatory diseases such as rheumatoid arthritis.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHR Orléans la Source - service de rhumatologie

location_facility: CHU de Toulouse - service de rhumatolgie

location_facility: CH des Pays de Morlaix - service de rhumatologie

location_facility: CHU de Montpellier - service de rhumatologie

location_facility: CH de Libourne - service de rhumatologie

location_facility: CHU de Bordeaux - service de rhumatologie

location_facility: CHU de Limoges - service de rhumatologie


title: MEMENTO-VAScular COmponents of Dementia

acronym: VASCOD

summary: A Multicenter national longitudinal cohort study including at least 800 individuals recruited from French Research Memory Centers and followed up over 36 months and included in Memento.

location_facility:
CHU d'Amiens
AP-HP - Hôpital BROCA
AP-HP - Hôpital LARIBOISIERE
CHU de Strasbourg
CHU de Dijon
CHU de Bordeaux - Pellegrin
CHU de Lille
CHU de Montpellier
AP-HM
Hospices civils de Lyon


title: Prevalence of Preoperative Short-acting Mimetic beta2 Therapy by Parents of Asthmatic Children Attending Emergency Room for Asthma Attack

acronym: ASPECT

summary:
prospective multicenter observational study. Parents whose children meet the inclusion criteria complete a questionnaire assessing the child's follow-up, the management of the current asthma attack, and the treatment provided at home.

The main objective is to calculate the prevalence of placement of short-acting bronchodilators. The secondary objectives are to describe the factors associated with their implementation.

location_facility:
Ch Quimper
CHRU de Brest


title: Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes. A Multicentre Study

summary: Sports training aims to enhance an athlete's performance (overcompensation). To do that, the athlete must go through periods of fatigue and lower performance (overreaching). When the training plan is balanced, this fatigue is short and reversible.If the training load is too heavy or if recuperation periods are too short, it can lead to persistence fatigue that may only be reversible in the long term. This state of fatigue is part of the broader clinical picture of overtraining, which includes stark changes in performance as well as mood and sleep disorders. Many prediction and characterization methods based on biological markers have been evaluated, but they have not been put into practice in sports training due to obstacles such as reliability, interindividual variability and high costs. This study aims to evaluate a new approach based on the variability of an individual's heart rate (RR variability), which is a way of measuring autonomic nervous system (ASN) activity. It is non-invasive, low-cost, and has already proven useful in athlete health monitoring.

location_facility:
CHU de Pointe à Pitre
CNSN Centre médical de Prémanon
CREPS Toulouse Midi Pyrénées
Université Paris XIII
CHU de Grenoble
CH Albertville Moutiers
CHU de Saint-Etienne
CHU de Besançon


title: Longitudinal Exploratory Prospective Evaluation of Clinical Evolution in Patients With Motor Predominant Parkinson Disease.

summary: The objective of this study is the longitudinal prospective clinical evaluation in patients with motor predominant PD; it will assess the individual disease progression (change) of the clinical and imaging parameters measured at 6-month interval over a minimum of 12 months.

status: Suspended

lead_sponsor: BrainEver

location_facility:
Hôpital Pitié-Salpétrière
Hôpital Henri Mondor


title: Oncologic Impact of Pancreatic Fistula After Distal Pancreatectomy for Pancratic Ductal Adenocarcinoma oh the Body and the Tail : a Multicentre Retrospective Cohort Analysis / POPF-DSS (Postoperative Pancreatic Fistula - Disease Specific Survival)

acronym: POPF-DSS

summary: Clinically-relevant post-operative fistula is a major complication after DP, but it did not affect post-operative therapeutic path nor oncologic long-term outcomes. CR-POPF was not a predictive factor for disease recurrence and it was not associated with an increased incidence of peritoneal or local relapse.

ReferenceCitation: Leon P, Giannone F, Belfiori G, Falconi M, Crippa S, Boggi U, Menonna F, Al Sadairi AR, Piardi T, Sulpice L, Gardini A, Sega V, Chirica M, Ravazzoni F, Giannandrea G, Pessaux P, de Blasi V, Navarro F, Panaro F. The Oncologic Impact of Pancreatic Fistula After Distal Pancreatectomy for Pancreatic Ductal Adenocarcinoma of the Body and the Tail: A Multicenter Retrospective Cohort Analysis. Ann Surg Oncol. 2021 Jun;28(6):3171-3183. doi: 10.1245/s10434-020-09310-y. Epub 2020 Nov 6.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: A Phase I, First in Human, Open-label Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia

summary:
This Phase 1 Study is an open-label, non-randomized, dose escalation, safety, efficacy, pharmacokinetic, and pharmacodynamic evaluation study of INA03 administered as a single agent IV infusion every 2 weeks to patients ≥18 years of age with R/R AML, MLL, or ALL.

The study will be performed in 2 parts: a Dose Titration for Day 1 study (Part 1) followed by a Dose Escalation Part (Part 2) of INA03 used as monotherapy.

ReferenceCitation: Kell J. Considerations and challenges for patients with refractory and relapsed acute myeloid leukaemia. Leuk Res. 2016 Aug;47:149-60. doi: 10.1016/j.leukres.2016.05.025. Epub 2016 Jun 11. Review.

ReferenceCitation: Döhner H, Dolnik A, Tang L, Seymour JF, Minden MD, Stone RM, Del Castillo TB, Al-Ali HK, Santini V, Vyas P, Beach CL, MacBeth KJ, Skikne BS, Songer S, Tu N, Bullinger L, Dombret H. Cytogenetics and gene mutations influence survival in older patients with acute myeloid leukemia treated with azacitidine or conventional care. Leukemia. 2018 Dec;32(12):2546-2557. doi: 10.1038/s41375-018-0257-z. Epub 2018 Oct 1.

ReferenceCitation: Eleni LD, Nicholas ZC, Alexandros S. Challenges in treating older patients with acute myeloid leukemia. J Oncol. 2010;2010:943823. doi: 10.1155/2010/943823. Epub 2010 Jun 10.

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lead_sponsor: Institut Paoli-Calmettes

location_facility:
IUCT
Institut Paoli-Calmettes


title: Évaluation Des modalités Optimales de Pilotage et de l'Impact Sur Les capacités de préhension d'Une Stimulation électrique Fonctionnelle Des Muscles Extenseurs Des Doigts Chez le Patient hémiplégique en Phase Chronique

acronym: PREHENSTROKE

summary:
Stroke is the leading cause of disability in adults. The improvement of the grasp abilities remains a challenge in the 50% of post-stroke subjects who have not recovered functional grasping due to paralysis of the finger's muscles (lack of active opening of the hand).

The use of functional electrical stimulation of the prehension muscles in order to restore grasp abilities, called grasp neuroprosthesis (GP), remained confidential in post-stroke subjects while their development was important in tetraplegic subjects. GP can provide a correct hand opening with significant functional gain, but one of the major issues corresponds to the control modalities that are not adapted to the specific impairments of post-stroke subjects.

This project proposes to assess the functional contribution of an innovative autopilot closed-loop GP targeting the extensor muscles of the fingers. The main hypothesis is that the use of GP will restore grasping abilities in subjects who have lost this ability due to post-stroke paralysis.

The main objective is to assess the impact of using an autopilot closed-loop GP on the ability to perform a standardized task of grasping, moving and releasing either a glass (palmar grasp) or a spoon (key pinch), compared to the absence of GP use.

The secondary objectives of the study are: (1) to assess the impact of the GP on unimanual grasp; (2) to assess which are the preferential modes of control; (3) to assess the psycho-social impacts of GP, and (4) to assess the subject's satisfaction and tolerance to the characteristics and use of GP.

The investigators plan to include 20 post-stroke hemiplegic subjects over a period of 9 months as part of a prospective, monocentric, multi-crossover, blinded evaluation study. Subjects will have active finger extension deficit secondary to stroke, with preservation of proximal movements. Each subject will be his own control (self-pairing).

Each subject will be evaluated three times, the protocol adding approximately 1½ hours of daily assessment to routine care already received. The first visit will collect clinical data after informed consent collection. The second visit will allow to choose the optimal mode of control of the GP among 8 modalities. The third visit will test the functional gain provided by the use of GP, by comparing the success or failure of carrying out functional tasks with inactive and active GP.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de TOULOUSE
CHU de Nîmes


acronym: TOUPIE

summary:
Idiopathic pulmonary fibrosis (IPF) is one of the most common chronic idiopathic fibrotic interstitial lung disease (ILD). IPF is an evolving disease that requires regular follow-up through clinical examination, respiratory functional investigations and thoracic CT. Thoracic CT is necessary for the follow-up, usually performed yearly, and in case of deterioration of respiratory function. The disadvantages to its realization are the repeated irradiation, the cost, the accessibility, and sometimes the difficulties of realization related to the supine position.

Several signs of thoracic ultrasound have been described in ILD, including the number of B lines, the irregularity of the pleural line, and the thickening of the pleural line. Cross-sectional studies have correlated the intensity of these signs with the severity of fibrosis lesions on chest CT in patients with ILD, including IPF. However, no studies have prospectively described the evolution of ultrasound signs in the same IPF patient, or their correlation to clinical, functional and CT scan evolution.

The hypothesis is that thoracic ultrasound is a relevant tool to highlight the evolution of pulmonary lesions in IPF.

The main objective is to show with thoracic ultrasound an increase in one or more of the ultrasound signs: line B score, pleural line irregularity score, and pleural line thickness during the follow-up of patient with IPF.

The study will enroll patients with a validated diagnosis of IPF in a multidisciplinary staff. At each follow-up visit, patients will have a clinical examination, pulmonary functional test and thoracic ultrasound. The CT data collected will include the last thoracic CT performed in the 3 months before the inclusion and those performed during the patient's participation. The presence, location and severity of ultrasound signs, will be recorded for each patient during successive reassessments and correlation to clinical, functional and CT scan evolution will be made.

This study will add significant knowledge in the study of ultrasound signs evolution in patients with IPF. If there is a correlation with the clinical or CT scores, it will be possible to carry over the realization of the CTs to limit the irradiation of the patients. Conversely, early detection of worsening ultrasound signs may lead to faster therapeutic adjustments to limit the extent of irreversible fibrotic lesions.

ReferenceCitation: Legué S, Marchand-Adam S, Plantier L, Bayeh BA, Morel H, Mangiapan G, Flament T. ThOracic Ultrasound in Idiopathic Pulmonary Fibrosis Evolution (TOUPIE): research protocol of a multicentric prospective study. BMJ Open. 2021 Mar 25;11(3):e039078. doi: 10.1136/bmjopen-2020-039078.

lead_sponsor: University Hospital, Tours

location_facility: Pulmonology Department, University Hospital, Tours


title: Immunomonitoring and Biomarker Research Based on Tumor and Blood Samples in Patients With Squamous Cell Anal Carcinoma

acronym: LAND

summary:
Even if squamous cell carcinoma of the anal canal (SCCA) is a rare disease, its incidence increases worldwide. SCCA is mostly induced by Human papillomavirus (HPV) infections and HPV-related oncoproteins (E6 and E7) are expressed in more than 90% of SCCA. T stage and N stage are recognized prognostic factors for local and/or distant recurrence in SCCA patients treated by chemoradiotherapy. In fact, ≥T3 or ≥N1 anal cancers are associated with as high as 50% of disease recurrence rate at 2 years.

The University Hospital of Besançon with the Gercor conducted a prospective clinical trial (Epitopes HPV02 study) including 69 advanced SCCA patients and established a new standard of care based on Docetaxel, Cisplatin and 5-FU (5-FluoroUracil) chemotherapy (DCF). Among 69 patients treated with DCF regimen, 66 patients were evaluable for efficacy end-points. The objective response rate was 86% including 44% of complete response, and 47% of patients were progression-free at 12 months of follow-up from the first cycle of DCF treatment. Thus, the "Epitopes-HPV02" trial has demonstrated a high response rate of the DCF regimen with a higher than expected 12 months progression-free survival rate.These results raised the hypothesis of DCF being an immunogenic chemotherapy and in that demonstrating a possibly new role of taxane-based chemotherapy in SCCA patients. More than 50% of patients in complete remission had a detectable immunological response against peptides derived from HPV oncoproteins (E6 or E7) or from the telomerase antigen (which is transactivated by E6).

LAND study will enroll patients with locally advanced SCCA enrolled in OPTIMANAL clinical trial. OPTIMANAL study will assess the feasibility and efficacy to combine nivolumab to mDCF chemotherapy, followed by the standard chemo-radiotherapy, in high risk locally advanced SCCA patients with T3/T4 N1a or N1b/N1c disease.

LAND study is an exploratory translational study, which will analyze the biological mechanisms of action and our ability to track the immune responses against HPV and telomerase. The investigator group will take advantage of the presence of HPV antigens in most patients to set up a specific immunomonitoring program based on tumor samples and blood-derived lymphocytes to better understand the potential synergisms between immunogenic chemotherapy and anti-PD1 (Programmed Death-1), and to identify valuable biomarkers of treatment efficacy.

status: Withdrawn

ReferenceCitation: Kim S, Jary M, André T, Vendrely V, Buecher B, François E, Bidard FC, Dumont S, Samalin E, Peiffert D, Pernot S, Baba-Hamed N, El Hajbi F, Bouché O, Desrame J, Parzy A, Zoubir M, Louvet C, Bachet JB, Nguyen T, Abdelghani MB, Smith D, De La Fouchardière C, Aparicio T, Bennouna J, Gornet JM, Jacquin M, Bonnetain F, Borg C. Docetaxel, Cisplatin, and 5-fluorouracil (DCF) chemotherapy in the treatment of metastatic or unresectable locally recurrent anal squamous cell carcinoma: a phase II study of French interdisciplinary GERCOR and FFCD groups (Epitopes-HPV02 study). BMC Cancer. 2017 Aug 25;17(1):574. doi: 10.1186/s12885-017-3566-0.

ReferenceCitation: Bernard-Tessier A, Jeannot E, Guenat D, Debernardi A, Michel M, Proudhon C, Vincent-Salomon A, Bièche I, Pierga JY, Buecher B, Meurisse A, François É, Cohen R, Jary M, Vendrely V, Samalin E, El Hajbi F, Baba-Hamed N, Borg C, Bidard FC, Kim S. Clinical Validity of HPV Circulating Tumor DNA in Advanced Anal Carcinoma: An Ancillary Study to the Epitopes-HPV02 Trial. Clin Cancer Res. 2019 Apr 1;25(7):2109-2115. doi: 10.1158/1078-0432.CCR-18-2984. Epub 2018 Nov 30.

ReferenceCitation: Kim S, François E, André T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, De La Fouchardiere C, Smith D, Deberne M, Spehner L, Badet N, Adotevi O, Anota A, Meurisse A, Vernerey D, Taieb J, Vendrely V, Buecher B, Borg C. Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2018 Aug;19(8):1094-1106. doi: 10.1016/S1470-2045(18)30321-8. Epub 2018 Jul 2.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Child's Study of the Distant Impact of Posterior Fossa Injury on Motor Skills, Language, Cognitive Functioning, and Social Cognition - a Combination of Clinical Assessments and Brain Imaging

acronym: CervIRM

summary: One of the major complications of posterior fossa surgery is Posterior Fossa Syndrome (PFS). This syndrome is due to a possible complication of surgical excision of a tumor of the cerebellum (4th ventricle) and is characterized by transient postoperative mutism, dysarthria, behavioral, and affective disorders, as well as motor disorders. PFS is thought to be related to axonal lesions. The long-term consequences on the cognitive and psychosocial sphere of PFS have been widely documented. On the other hand, the literature concerning the consequences of this syndrome on language is much restricted. Beyond the language, the role of cerebellum would be central in cognition, some authors even comparing it to a great "conductor" who would underlie the learning of most motor and cognitive automatisms.

time_perspective: Other

lead_sponsor: University Hospital, Angers

location_facility:
Hôpitaux Saint-Maurice
CHU Angers
Hôpital Necker
Institut Curie
Gustave Roussy


title: A Phase II Study Evaluating the Interest to Combine UCPVax a CD4 TH1-inducer Cancer Vaccine and Atezolizumab for the Treatment of Human PapillomaVirus Positive Cancers

acronym: VolATIL

summary:
70% all cases of cervical cancer, 95% of anal cancers and about 70% of oropharyngeal cancers are linked to Human Papillomavirus (HPV) infection. HPV oncogenic proteins are trans-activators of telomerase. Indeed, E6 oncoprotein transactivates the human telomerase (hTert). Our group has conducted a clinical trial (NCT02402842) in advanced squamous cell anal cancer (SCCA) and investigators have shown a correlation between the presence of anti-HPV immunity and anti-telomerase T helpher 1 (TH1) CD4 T cell responses, establishing telomerase as an appropriate antigen in HPV-related cancers.

Tumor-reactive CD4+ T cells have been found to ensure efficient effector Cytotoxic T Lymphocytes (CTL) recruitment at the tumor site. Promoting tumor specific TH1 CD4 activation might be an attractive therapeutic option to enhance anti-PD-1/PD-L1 (Programmed cell Death-1/Programmed cell Death-Ligand1) efficacy. However, no option is currently available to expand tumor specific TH1 lymphocytes in most patients. Then, investigators have identified four novel MHC (Major Histocompatibility Complex) class II-restricted peptides derived from human telomerase reverse transcriptase (TERT) referred as "Universal Cancer Peptides" (UCP). UCPVax is a therapeutic cancer vaccine developed by our team and composed of two separate peptides called UCP2 and UCP4 derived from telomerase. This UCPVax vaccine is currently evaluated in a multicenter phase I/II study in Non Small Lung Cancer (NSCLC) (NCT2818426) and seems to show to be safe and immunogenic.

PD-1/PD-L1 immune checkpoint is a relevant candidate target for immunotherapy in HPV+ cancers, based on the prominent role of PD-1 and its ligand PD-L1 in HPV-driven immune-evasion. There is a strong rational of using PD-1 therapy in HPV+ cancers, however anti-PD-1/PD-L1 treatment induces a limited number of long term responses in HPV disease. Combining anti-PD-1/PD-L1 therapy with an antitumor vaccine gains serious consideration in HPV+ cancers. Indeed, anti-cancer vaccines can induce tumor-specific T cells expansion and activation and therefore restore the cancer-immunity cycle in patients lacking pre-existing anti-tumor responses.

So investigators propose to determine the clinical interest and immunological efficacy of a treatment combining the CD4 helper T-inducer cancer vaccine (UCPVax) with atezolizumab in patients with HPV+ cancers by evaluation of the objective response rate at 4 months according to iRecist criteria.

ReferenceCitation: Godet Y, Fabre E, Dosset M, Lamuraglia M, Levionnois E, Ravel P, Benhamouda N, Cazes A, Le Pimpec-Barthes F, Gaugler B, Langlade-Demoyen P, Pivot X, Saas P, Maillère B, Tartour E, Borg C, Adotévi O. Analysis of spontaneous tumor-specific CD4 T-cell immunity in lung cancer using promiscuous HLA-DR telomerase-derived epitopes: potential synergistic effect with chemotherapy response. Clin Cancer Res. 2012 May 15;18(10):2943-53. doi: 10.1158/1078-0432.CCR-11-3185. Epub 2012 Mar 8.

ReferenceCitation: Dosset M, Godet Y, Vauchy C, Beziaud L, Lone YC, Sedlik C, Liard C, Levionnois E, Clerc B, Sandoval F, Daguindau E, Wain-Hobson S, Tartour E, Langlade-Demoyen P, Borg C, Adotévi O. Universal cancer peptide-based therapeutic vaccine breaks tolerance against telomerase and eradicates established tumor. Clin Cancer Res. 2012 Nov 15;18(22):6284-95. doi: 10.1158/1078-0432.CCR-12-0896. Epub 2012 Oct 2.

ReferenceCitation: Dosset M, Vauchy C, Beziaud L, Adotevi O, Godet Y. Universal tumor-reactive helper peptides from telomerase as new tools for anticancer vaccination. Oncoimmunology. 2013 Mar 1;2(3):e23430.

ReferenceCitation: Rebucci-Peixoto M, Vienot A, Adotevi O, Jacquin M, Ghiringhelli F, de la Fouchardière C, You B, Maurina T, Kalbacher E, Bazan F, Meynard G, Clairet AL, Fagnoni-Legat C, Spehner L, Bouard A, Vernerey D, Meurisse A, Kim S, Borg C, Mansi L. A Phase II Study Evaluating the Interest to Combine UCPVax, a Telomerase CD4 T(H)1-Inducer Cancer Vaccine, and Atezolizumab for the Treatment of HPV Positive Cancers: VolATIL Study. Front Oncol. 2022 Jul 19;12:957580. doi: 10.3389/fonc.2022.957580. eCollection 2022.

location_facility:
Centre Georges François Leclerc
Centre Léon Bérard
Institut Curie
Hospices Civils de Lyon
CHU de Besançon


title: Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis

acronym: EXPOSOMFPI

summary: Idiopathic Pulmonary Fibrosis(IPF) is the most common idiopathic interstitial lung disease whose cause is unknown. With age and gender, socio-economic factors are the most influential indicators of health. At present there is very little data on socio-economic factors in the IPF. The investigators hypothesize that a lower socio-economic level and / or exposure to various air pollutants may influence the IPF's natural history, including the severity of diagnosis and prognosis of the IPF. The investigators also hypothesize that the deleterious effect of air pollutants is modulated by individual susceptibility (shorter telomeres) and that this effect is related to oxidative stress and shortening of telomeres.

ReferenceCitation: Duchemann B, Annesi-Maesano I, Jacobe de Naurois C, Sanyal S, Brillet PY, Brauner M, Kambouchner M, Huynh S, Naccache JM, Borie R, Piquet J, Mekinian A, Virally J, Uzunhan Y, Cadranel J, Crestani B, Fain O, Lhote F, Dhote R, Saidenberg-Kermanac'h N, Rosental PA, Valeyre D, Nunes H. Prevalence and incidence of interstitial lung diseases in a multi-ethnic county of Greater Paris. Eur Respir J. 2017 Aug 3;50(2). pii: 1602419. doi: 10.1183/13993003.02419-2016. Print 2017 Aug.

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ReferenceCitation: Raghu G, Rochwerg B, Zhang Y, Garcia CA, Azuma A, Behr J, Brozek JL, Collard HR, Cunningham W, Homma S, Johkoh T, Martinez FJ, Myers J, Protzko SL, Richeldi L, Rind D, Selman M, Theodore A, Wells AU, Hoogsteden H, Schünemann HJ; American Thoracic Society; European Respiratory society; Japanese Respiratory Society; Latin American Thoracic Association. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis. An Update of the 2011 Clinical Practice Guideline. Am J Respir Crit Care Med. 2015 Jul 15;192(2):e3-19. doi: 10.1164/rccm.201506-1063ST. Erratum in: Am J Respir Crit Care Med. 2015 Sep 1;192(5):644. Dosage error in article text.

ReferenceCitation: Cottin V. [French recommendations for idiopathic pulmonary fibrosis: An updated working document for clinicians]. Rev Mal Respir. 2017 Oct;34(8):789-790. doi: 10.1016/j.rmr.2017.09.005. French.

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ReferenceCitation: Collard HR, Ryerson CJ, Corte TJ, Jenkins G, Kondoh Y, Lederer DJ, Lee JS, Maher TM, Wells AU, Antoniou KM, Behr J, Brown KK, Cottin V, Flaherty KR, Fukuoka J, Hansell DM, Johkoh T, Kaminski N, Kim DS, Kolb M, Lynch DA, Myers JL, Raghu G, Richeldi L, Taniguchi H, Martinez FJ. Acute Exacerbation of Idiopathic Pulmonary Fibrosis. An International Working Group Report. Am J Respir Crit Care Med. 2016 Aug 1;194(3):265-75. doi: 10.1164/rccm.201604-0801CI. Review.

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lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: 002 - Service Explorations Fonctionnelles Respiratoires


title: Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study: From Proper Assessment to Trial Needs - IMAGiNe Study-Lyon/Bicêtre

summary:
There is no international consensus regarding how to assess and treat patients with immunoglobulin M (IgM)-anti-myelin-associated-glycoprotein (MAG) monoclonal gammopathy associated peripheral neuropathy. The purpose of the IMAGiNe study-Lyon/Bicêtre is to prospectively collect standardized clinical data of 25 patients with IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy in order to participate in the international IMAGiNe Study.

The main objective is to describe in detail the various clinical subtypes, clinical course, treatment responses, antibody titers of IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy using a variety of outcome measures. The obtained observational data will allow the construction of an IgM monoclonal gammopathy associated peripheral neuropathy-specific Rasch-built overall Disability Scale (RODS) that should fulfill all modern clinimetric requirements, including cross-cultural validity. The coordinating centers for the IgM-RODS construction will be the Maastricht University Medical Center and University Medical Center Utrecht, both in the Netherlands.

location_facility: Hospices Civils de Lyon Service Neurologie C, Pathologies Neuromusculaires, Unité 302


title: Study of Lipopolysaccharide Metabolism for Identification of New Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation

acronym: MetAlloLip

summary: This study is designed to assess the hypothesis that the lipopolysaccharide (LPS) activity index can be quantified early after transplantation, as well as the the PhosphoLipid Transfer Protein (PLTP) activity and these both biological variables are independent variables for predicting the risk of severe Graft versus Host Disease (GVHD).

location_facility: Centre Hospitalier Universitaire de Nancy