title: Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis, a National Prospective Multicentre Study

acronym: PRO-SURFASA

summary:
Autoimmune hepatitis (AIH) is a chronic liver disease, which is characterized by the increase of immunoglobulin G (IgG) level, the presence of auto-antibodies and a typical histology, in the absence of other liver disease.

Due to the heterogeneity of AIH manifestations, different scoring systems have been validated in order to make a reliable diagnosis. The two most recent scoring systems are: the revised International Autoimmune Hepatitis Group (IAIHG) criteria and the IAIHG simplified criteria. The second one is recommended by the European Association for the Study of the Liver (EASL) clinical practice guidelines (CPGs).

The EASL clinical practice guidelines suggests that the treatment of ASAIH (Acute Severe AIH) is high doses of corticosteroids (superior to 1mg/kg/day) as early as possible and a lack of improvement within seven days should lead to listing for emergency liver transplantation (LT). However, the "lack of improvement" is not objectively defined and the grading of recommendation is III (Opinions of respected authorities).

The hypothesis of the study is that the previously developed decisional score on a retrospective series will prospectively allow the differentiation between patients with ASAIH (Acute Severe AIH) who respond to corticosteroid therapy and should be maintained on treatment and patients who do not respond and should be rapidly evaluated for LT. The score will be computed at day 3 since corticosteroid introduction.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: CHU Montpellier, Hopital Saint Eloi, Service Hepato-gastro-enterologie

location_facility: CHU La Miletrie, Service Hepato-gastro-enterologie

location_facility: CHRU de Lille, Hopital Claude Huriez, Service des maladies de l'appareil digestif et de la nutrition

location_facility: CHU Nice, Hopital de l'Archet 2, Service Hepatologie

location_facility: CHU de Rennes, Hopital de Pontchaillou, Service Maladie du foie

location_facility: CHU Grenoble Alpes Hopital Nord, Service Hepato-gastro-enterologie

location_facility: CHU Angers, Service Hepato-gastro-enterologie

location_facility: CHU Trousseau Chambray, Service Gastro-enterologie et hepatologie

location_facility: CHU Limoges, Hopital Dupuytren, Service Hepato-gastroenterologie et nutrition

location_facility: Hopital Saint Joseph, Service Hepato-gastro-enterologie

location_facility: CHU Toulouse, Hopital Rangueil, Service Hepatologie

location_facility: CHU Orleans, Hopital de la Source, Service Gastro-enterologie et hepatologie

location_facility: CHU Rouen, Service d'hepatogastro-enterologie

location_facility: CHU Strasbourg, Hopital de Hautepierre, Service Hepato-gastro-enterologie

location_facility: APHP, Hopital Jean Verdier, Service Hepatologie

location_facility: APHP, Hopital Pitie-Salpetriere, Service d'hepatologie et de gastroenterologie

location_facility: CHU Hopital Edouard Herriot, Service Hepato-gastro-enterologie

location_facility: CHU Reims, Hopital Robert Debré, Service Hepato-Gastroenterologie et de Cancerologie digestive

location_facility: AP-HP, Hopital St Antoine, Service Hepato-gastro-enterologie

location_facility: CHU Lyon, Hopital Croix Rousse, Service Hepato-gastro-enterologie

location_facility: AP-HP, Hopital Cochin Service Hepatologie

location_facility: CHU Jean Minjoz Besançon, Service d'hepatologie et de soins intensifs digestifs

location_facility: CHU Bordeaux, GH Sud Haut-Leveque, Service Hepato-gastro-enterologie

location_facility: AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire

location_facility: CHU Dijon, Service Hepato-gastroenterologie et cancerologie digestive

location_facility: CHU Brest, Hopital de la Cavale Blanche Service Gastro-enterologie

location_facility: CHU de Caen, Hopital de la Cote de Nacre, Service Hepato-Gastro-Enterologie et Nutrition

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: Pro-SURFASA

titre: Validation d'un score pronostique de la réponse au traitement par les stéroïdes dans l'hépatite auto-immune aiguë sévère, une étude multicentrique prospective nationale

discipline_principale: hépatologie

nom_porteur: De Martin

prenom_porteur: Eleonora


title: Transplantation After Complete Response In Patients With T-cell Lymphoma

acronym: TRANSCRIPT

summary:
Peripheral T-cell lymphoma (PTCL) encompasses a broad range of post-thymic (i.e., mature) sub-entities as defined by the 2017 WHO classification. The most common entities are angioimmunoblastic T-cell lymphoma (AITL) and other Tfh-phenotype PTCL or PTCL not otherwise specified (NOS), each representing approximately 20 to 25% of mature T- and NK/T-cell lymphomas. Compared to their B-cell counterparts, most PTCL confer dismal prognosis. In fact, except for anaplastic lymphoma kinase (ALK)-positive systemic anaplastic large cell lymphoma (sALCL), 10-year overall survival for patients with PTCL barely exceeds 30%. Given the infrequency and the heterogeneity of these malignancies, no real consensus on first-line treatment has been established for most PTCL.

The place of autologous stem cell transplantation (ASCT) as a consolidation procedure for patients with PTCL achieving a complete metabolic response after induction is still highly debated. ESMO recommendations and recent guidelines from a committee of the American Society for Blood and Marrow Transplantation currently propose ASCT as first-line therapy for transplant-eligible patients for all patients reaching at least a partial response (PR) after induction. NCCN guidelines (version 2.2017) recommend ASCT or observation in case of metabolic CR but salvage regimen in case of residual disease after induction.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Health Services Research

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_facility: Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL

location_facility: Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,

location_facility: Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine

location_facility: Service Hématologie, Institut Curie - Hôpital René HUGUENIN

location_facility: Ch de Valenciennes - Hopital Jean Bernard

location_facility: Institut Cancerologie & Hematologie St-Etienne

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: Dosing of Various Multi Kinases Inhibitors Plasma Concentrations for Patients Treated for Their Advanced Digestive Cancer, With the Aim to Determine the Best Optimal Dose for Each Treatment, in the Future

acronym: TARGETMONITO

summary: Targeted therapy drug monitoring in digestive oncology: Dosage of plasma levels of various multikinase inhibitors (MKI) in patients treated for advanced digestive cancer (gastrointestinal stromal tumor (GIST), metastatic colorectal cancer (mCRC), hepatocellular carcinoma (HCC), gastroenteropancreatic neuroendocrine tumor (gepNET), or pancreatic neuroendocrine tumor (pNET)), with the aim of determine the optimal dose adapted for each patient, in the future.

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: UNICANCER

location_facility: Groupement des hôpitaux de l'Institut Catholique de Lille - Hôpital Saint Vincent de Paul

location_facility: Institut du Cancer Avignon - Institut Sainte Catherine

location_facility: CHRU de Nancy - Hôpital de Brabois Adulte

intervention_type: Other

lead_sponsor_type: industriel


title: Interest of Nitazoxanide Treatment of Enterocytozoon Bieneusi Intestinal Microsporidiosis

acronym: NITAZO-SPORE

summary: Microsporidia are pathogenic fungi mainly responsible for profuse watery diarrhea, requiring management in immunocompromised patients. The main immunocompromised population affected by these infections consists of solid organ transplant recipients (SOT), mainly kidney (~70% of cases in immunocompromised patients). In this population, the infection is severe, and becomes chronic in the absence of appropriate care, the species Enterocytozoon bieneusi being found in more than 95% of these cases. Reducing immunosuppression (adjustment of immunosuppressive therapy) can sometimes be enough to eliminate the pathogen. However, in some cases, specific treatment is necessary. The only molecule whose efficacy has been proven to date to treat infections caused by E. bieneusi is fumagillin (FLISINT®), however its production has been stopped for almost 2 years. Due to the therapeutic impasse, the use of nitazoxanide (ALINIA®) to treat E. bieneusi microsporidiosis is becoming common, despite the lack of proof of its efficacy. It seems important and urgent to evaluate the relevance of the use of nitazoxanide, particularly in SOT, for the treatment of intestinal microsporidiosis due to E. bieneusi.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: University Hospital, Clermont-Ferrand

location_country: Guadeloupe France

location_facility: AP-HP Hopitaux Universitaires Henri-Mondor

status_simplified: Completed


title: French Registry to Evaluate the Safety and Efficacy of the Diamondback 360TM Orbital Atherectomy System in the Preparation of Calcified Coronary Lesions Before Implantation of a Coronary Endoprothesis

acronym: REFORCE

summary: This is a French, prospective, single-arm, multi-center registry to confirm the safety and efficacy of the Diamondback 360 TM Orbital Atherectomy System in the preparation of de novo calcified coronary lesions before implantation of a coronary endoprothesis in adult subjects. The primary safety endpoint is 30-day MACE and the efficacy endpoint is procedural success.

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Sturm R, Martinsen BJ, Valle JA, Waldo SW, Behrens AN, Armstrong EJ. Orbital Atherectomy for Treatment of Complex Severely Calcified Coronary Artery Lesions: Insights from a Veterans Affairs Cohort. Cardiovasc Revasc Med. 2020 Mar;21(3):330-333. doi: 10.1016/j.carrev.2019.06.013. Epub 2019 Jun 28.

ReferenceCitation: Mosseri M, Satler LF, Pichard AD, Waksman R. Impact of vessel calcification on outcomes after coronary stenting. Cardiovasc Revasc Med. 2005 Oct-Dec;6(4):147-53. doi: 10.1016/j.carrev.2005.08.008.

ReferenceCitation: Onuma Y, Tanimoto S, Ruygrok P, Neuzner J, Piek JJ, Seth A, Schofer JJ, Richardt G, Wiemer M, Carrie D, Thuesen L, Dorange C, Miquel-Hebert K, Veldhof S, Serruys PW. Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: two-year angiographic and three-year clinical results from the SPIRIT II study. Catheter Cardiovasc Interv. 2010 Nov 1;76(5):634-42. doi: 10.1002/ccd.22541.

ReferenceCitation: Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation. 1992 Jul;86(1):64-70. doi: 10.1161/01.cir.86.1.64.

ReferenceCitation: Moussa I, Di Mario C, Moses J, Reimers B, Di Francesco L, Martini G, Tobis J, Colombo A. Coronary stenting after rotational atherectomy in calcified and complex lesions. Angiographic and clinical follow-up results. Circulation. 1997 Jul 1;96(1):128-36. doi: 10.1161/01.cir.96.1.128.

ReferenceCitation: Bhatt P, Parikh P, Patel A, Chag M, Chandarana A, Parikh R, Parikh K. Orbital atherectomy system in treating calcified coronary lesions: 3-Year follow-up in first human use study (ORBIT I trial). Cardiovasc Revasc Med. 2014 Jun;15(4):204-8. doi: 10.1016/j.carrev.2014.03.004. Epub 2014 Mar 19.

ReferenceCitation: Chambers JW, Feldman RL, Himmelstein SI, Bhatheja R, Villa AE, Strickman NE, Shlofmitz RA, Dulas DD, Arab D, Khanna PK, Lee AC, Ghali MG, Shah RR, Davis TP, Kim CY, Tai Z, Patel KC, Puma JA, Makam P, Bertolet BD, Nseir GY. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). JACC Cardiovasc Interv. 2014 May;7(5):510-8. doi: 10.1016/j.jcin.2014.01.158.

ReferenceCitation: Benezet J, Diaz de la Llera LS, Cubero JM, Villa M, Fernandez-Quero M, Sanchez-Gonzalez A. Drug-eluting stents following rotational atherectomy for heavily calcified coronary lesions: long-term clinical outcomes. J Invasive Cardiol. 2011 Jan;23(1):28-32.

ReferenceCitation: Bouisset F, Barbato E, Reczuch K, Dobrzycki S, Meyer-Gessner M, Bressollette E, Cayla G, Lhermusier T, Zajdel W, Palazuelos Molinero J, Ferenc M, Ribichini FL, Carrie D. Clinical outcomes of PCI with rotational atherectomy: the European multicentre Euro4C registry. EuroIntervention. 2020 Jul 17;16(4):e305-e312. doi: 10.4244/EIJ-D-19-01129.

ReferenceCitation: Kobayashi Y, Okura H, Kume T, Yamada R, Kobayashi Y, Fukuhara K, Koyama T, Nezuo S, Neishi Y, Hayashida A, Kawamoto T, Yoshida K. Impact of target lesion coronary calcification on stent expansion. Circ J. 2014;78(9):2209-14. doi: 10.1253/circj.cj-14-0108. Epub 2014 Jul 14.

ReferenceCitation: Genereux P, Madhavan MV, Mintz GS, Maehara A, Palmerini T, Lasalle L, Xu K, McAndrew T, Kirtane A, Lansky AJ, Brener SJ, Mehran R, Stone GW. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol. 2014 May 13;63(18):1845-54. doi: 10.1016/j.jacc.2014.01.034. Epub 2014 Feb 19.

ReferenceCitation: Parikh K, Chandra P, Choksi N, Khanna P, Chambers J. Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions: the ORBIT I trial. Catheter Cardiovasc Interv. 2013 Jun 1;81(7):1134-9. doi: 10.1002/ccd.24700. Epub 2013 Mar 5.

ReferenceCitation: Lee M, Genereux P, Shlofmitz R, Phillipson D, Anose BM, Martinsen BJ, Himmelstein SI, Chambers JW. Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial. Cardiovasc Revasc Med. 2017 Jun;18(4):261-264. doi: 10.1016/j.carrev.2017.01.011. Epub 2017 Jan 23.

lead_sponsor: Centre Recherche Cardio Vasculaire Alpes

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Centre Hospitalier Antibes - Juan-Les-Pins

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne/Mer

location_facility: Centre Hospitalier Universitaire de Nîmes

intervention_type: Device


title: Intravascular Lithotripsy in Comparison to Rotational Atherectomy: An Evaluation by OFDI

acronym: ICARE

summary: The ICARE trial will aim to assess the efficacy of rotational atherectomy by Rotablator and Intravascular Lithotripsy by C2 Shockwave Medical® (IVL) in a randomized fashion in highly calcified lesions measured by final minimal stent area (MSA) on Optical Frequency Domain Imaging (OFDI). The investigator hypothesize that there will be no significant difference in final MSA in OFDI between the two groups after angioplasty with a last generation drug eluting stent ULTIMASTER TANSEI.

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Clinique Pasteur Toulouse

location_facility: Hôpital Européen de Paris GVM la Roseraie


title: Prospective and Multicentric Study Evaluating DNA Double-strand Breaks (DSBs) REpair Factors (POLQ, Shieldin Complex and 53BP1) Expression as Biomarker of PARP Inhibitor Resistance in Patients With Deleterious Germline Mutation in BRCA 1/2 and HER2-negative, Metastatic or Locally Advanced Breast Cancer.

acronym: REPARP

summary:
The purpose of this study is to assess whether expression of not only POLQ/Polθ, but also Shieldin complex and/or 53BP1 are correlated with primary and/or acquired resistance to PARPi (Poly(ADP-Ribose) Polymerases inhibitors) in a sub-population of locally advanced or metastatic breast cancer patients and vary regarding type and location of gBRCA1/2 mutations.

This translational research program is composed of two multicentric, non-randomized prospective studies in patients with HER2-negative locally advanced or metastatic breast cancer:

The main study concerns 80 patients eligible for PARPi (according to the investigators).PARPi treatments (talazoparib or olaparib) will be administered and dosed according to the standard of care administration.
The sub-study concerns 40 patients in progression disease under PARPi alone.

For each included patient in the main study or sub-study, tumor biopsy specimen and blood samples will be collected at different times during the study.

primary_purpose: Other

lead_sponsor: Institut Claudius Regaud

sponsor_collaborators:
Institut Claudius Regaud
Artios Pharma Ltd

location_facility: INSTITUT DE CANCEROLOGIE DE L'OUEST St-Herblain

location_facility: Centre de Cancerologie Du Grand Montpellier

location_facility: Institut Regional Du Cancer de Montpellier

location_facility: CENTRE ARMORICAIN DE RADIOTHERAPIE, IMAGERIE MEDICALE ET ONCOLOGIE - Hôpital privé des Côtes d'Armor


title: Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma: A Retrospective Study

acronym: ENDOVIE

summary: This is a national observational retrospective multi-site chart review study of patients with advanced, recurrent or metastatic endometrial carcinoma.

lead_sponsor: ARCAGY/ GINECO GROUP

sponsor_collaborators:
ARCAGY/ GINECO GROUP
Merck Sharp & Dohme LLC

location_facility: ICANS - Institut de cancérologie Strasbourg Europe

location_facility: Groupe Hospitalier Diaconesses - Croix Saint-Simon

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre ONCOGARD - Institut de cancérologie du Gard

location_facility: Centre d'Oncologie et de Radiothérapie 37

location_facility: Sainte-Catherine Institut du Cancer Avignon-Provence

intervention_type: Drug


title: Assessment of the Impact of the Postponement of Surgery on the Postoperative Morbidity After Sars-cov-2 Infection in 2022

summary: The deployment of vaccination against SARS-CoV-2 from 2021 led to a modification in June 2021of previous recommendations concerning the postponing scheduled surgery suggesting local adaptations of this delay if epidemic developments appear. Today, the evolutions of the pandemic make these recommendations obsolete and impose the updating of the data produced during the first epidemic wave of 2020. Among these evolutions, the two most important are the existence of a large vaccination coverage on the one hand and the emergence of variants of lesser severity on the other hand

lead_sponsor: Société Française d'Anesthésie et de Réanimation

location_facility: Polyclinique de Villeneuve Saint Georges

location_facility: Hôpital E. Herriot - Hospices Civils de Lyon

location_facility: AP-HP - Groupe Hospitalier Pitié-Salpêtrière (bloc central)

location_facility: CH Charleville Mézière - CH Intercommunal Nord Ardennes


title: Air Leak Test in Pediatric Intensive Care Unit : a Multicentric and Prospective Study

acronym: ALTIPICU

summary:
Respiratory distress by upper airway obstruction (UAO) is the primary etiology of extubation failure in children hospitalized in pediatric intensive care unit (PICU).

This complication may require various invasive therapeutic which increase morbi-mortality and length of hospital stay.

Cuff leak test (CLT) measured prior extubation to predict post-extubation UAO has been widely used in adult. The test compared expired tidal volume with cuff inflated and cuff deflated in order to predict UAO.

Despite its frequent use in PICU, his predictive value to predict UAO in children is still poorly documented.

Therefore, we conducted the first multicentric, prospective study to evaluate the CLT as a predictor of post-extubation UAO in critically ill children.

The Primary objective is to assess the effectiveness of CLT in predicting severe respiratory distress by UAO within 48 hours of extubation in a critically ill children.

ipd_sharing: Undecided

location_facility: Hôpital Haut-Lévêques, réanimation chirurgicale cardiopédiatrique

location_facility: Hôpital Haut-Lévêques, maladies cardio-vasculaires congénitales

location_facility: Necker, AP-HP Centre - Médecine intensive


title: A Randomised Phase II Placebo-controlled Trial of Antiretroviral Therapy (ART) Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs) vs ART Plus Placebo During Primary HIV-1 Infection to Study the Impact on Post-treatment HIV Control.

summary: RHIVIERA-02 trial is a placebo-controlled double-blinded two arm prospective phase II trial. This study will test the use of broadly neutralising antibodies (bNAbs) in participants, at primary HIV infection (PHI) and ART initiation.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: ANRS, Emerging Infectious Diseases

collaborators:
Rockefeller University
Institut Pasteur

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Rockefeller University
Institut Pasteur

location_facility: Centre médico chirurgical Foch - Suresnes

location_facility: Hôpital Lariboisière - Service de médecine interne A

location_facility: Hôpital Beaujon - Service de médecine interne

location_facility: Hôpital Hôtel Dieu - Service d'immunologie clinique

location_facility: Hôpital Bicêtre - HdJ - Médecine interne


title: Neoadjuvant and Adjuvant Ribociclib and Endocrine Therapy for Clinically High-risk Estrogen Receptor-positive (ER+) and HER2-negative (HER2-) Breast Cancer

acronym: RIBOLARIS

summary:
This is an open-label, multicenter international trial in men and women with primary operable HR+/HER2-, ki67≥20%, grade 2 or 3 and stage II breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in patients biologically responders to neoadjuvant ribociclib and letrozole.

This study aims to evaluate whether chemotherapy could be avoided for initial high-risk clinicopathological breast cancer patients that are converted to low genomic risk assessed by Risk of Recurrence-low (ROR-low) at 6 months of letrozole - ribociclib neoadjuvant treatment by continuing with this treatment in adjuvant setting.

lead_sponsor: SOLTI Breast Cancer Research Group

collaborators: Novartis UNICANCER

sponsor_collaborators:
SOLTI Breast Cancer Research Group
Novartis
UNICANCER

location_country: Spain Portugal France

location_facility: Sainte Catherine - Institut du Cancer Avignon Provence

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Clinique Mutualiste de l'Estuaire - Groupe HGO

location_facility: Centre Hospitalier Universitaire de Grenoble Alpes

location_facility: Hospital Universiatrio Clínico San Cecilio

location_facility: Clinique Sainte Anne - Strasbourg Oncologie Libérale

location_facility: Complejo Asistencial Universitario de Salamanca

location_facility: Hôpital Franco Britanique Fondation Cognacq Jay

location_facility: Complejo Asistencial Universitario de León

location_facility: Centre Hospitalier Universitaire de Besancon

location_facility: Institut de cancérologie Strasbourg Europe - ICANS

location_facility: Centre Hospitalier Universitaire de Poitiers


title: Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term Retro-Prospective, Non-Randomized, Non-Interventional Study

summary:
This study takes place in the framework of the Post-Market Clinical Follow-up of the FX Solutions Shoulder System. The goal of this PMCF study is to collect clinical data in order to confirm the safety and the performance at a long term and mainly the first two years of sales for each studied ranges.

Eligible patients who received the FX Solutions Shoulder System and are at about 7 years post-operative were contacted by the Investigator to explain the study, the retrospective collection and the prospective follow-up visit. Investigator also explain the analysis of the post-operative outcomes of the patient. During the call of the investigator, the patient was informed about the study's goal and about the data collection. The oral agreement of the patient was checked by the investigators in CRF with its signature. Then, an information form explaining the purpose of the data collection was provided to the patient by postmail.

The retrospective data were collected in a paper CRF via the medical file of patient.

Post-operative follow-up for all patients is limited to a teleconsultation intended to assess the patient's current condition and clinical outcomes.

Patient who are enrolled in the study shall be assigned a unique Subject Identification Number to de-identify their information.

ReferenceCitation: Churchill RS. Stemless shoulder arthroplasty: current status. J Shoulder Elbow Surg. 2014 Sep;23(9):1409-14. doi: 10.1016/j.jse.2014.05.005. Epub 2014 Jul 11.

ReferenceCitation: Cuff D, Pupello D, Virani N, Levy J, Frankle M. Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency. J Bone Joint Surg Am. 2008 Jun;90(6):1244-51. doi: 10.2106/JBJS.G.00775.

ReferenceCitation: De Wilde LF, Audenaert EA, Berghs BM. Shoulder prostheses treating cuff tear arthropathy: a comparative biomechanical study. J Orthop Res. 2004 Nov;22(6):1222-30. doi: 10.1016/j.orthres.2004.03.010.

ReferenceCitation: Frankle M, Levy JC, Pupello D, Siegal S, Saleem A, Mighell M, Vasey M. The reverse shoulder prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency. a minimum two-year follow-up study of sixty patients surgical technique. J Bone Joint Surg Am. 2006 Sep;88 Suppl 1 Pt 2:178-90. doi: 10.2106/JBJS.F.00123.

ReferenceCitation: Franklin JL, Barrett WP, Jackins SE, Matsen FA 3rd. Glenoid loosening in total shoulder arthroplasty. Association with rotator cuff deficiency. J Arthroplasty. 1988;3(1):39-46. doi: 10.1016/s0883-5403(88)80051-2.

ReferenceCitation: Hawi N, Magosch P, Tauber M, Lichtenberg S, Habermeyer P. Nine-year outcome after anatomic stemless shoulder prosthesis: clinical and radiologic results. J Shoulder Elbow Surg. 2017 Sep;26(9):1609-1615. doi: 10.1016/j.jse.2017.02.017. Epub 2017 Apr 11.

ReferenceCitation: Hawi N, Tauber M, Messina MJ, Habermeyer P, Martetschlager F. Anatomic stemless shoulder arthroplasty and related outcomes: a systematic review. BMC Musculoskelet Disord. 2016 Aug 30;17(1):376. doi: 10.1186/s12891-016-1235-0.

ReferenceCitation: Jazayeri R, Kwon YW. Evolution of the reverse total shoulder prosthesis. Bull NYU Hosp Jt Dis. 2011;69(1):50-5.

ReferenceCitation: Lugli T. Artificial shoulder joint by Pean (1893): the facts of an exceptional intervention and the prosthetic method. Clin Orthop Relat Res. 1978 Jun;(133):215-8.

ReferenceCitation: NEER CS 2nd. Articular replacement for the humeral head. J Bone Joint Surg Am. 1955 Apr;37-A(2):215-28. No abstract available.

ReferenceCitation: Neer CS 2nd, Craig EV, Fukuda H. Cuff-tear arthropathy. J Bone Joint Surg Am. 1983 Dec;65(9):1232-44.

ReferenceCitation: Neer CS 2nd, Watson KC, Stanton FJ. Recent experience in total shoulder replacement. J Bone Joint Surg Am. 1982 Mar;64(3):319-37. No abstract available.

ReferenceCitation: Post M, Jablon M, Miller H, Singh M. Constrained total shoulder joint replacement: a critical review. Clin Orthop Relat Res. 1979 Oct;(144):135-50.

ipd_sharing_description: No plan to share IDP for this study

lead_sponsor: FX Solutions

location_country: Monaco France

location_facility:
Clinique La Montagne
Clinique Jouvenet
CHU Jean MINJOZ
Clinique Convert
Centre Hospitalier de Dieppe
Clinique Mutualiste la Sagesse
Hôpital Privé Antony
Hopital Privé Claude Gallien
Clinique des Maussins
Centre Hospitalier de St Malo
Centre Hospitalier Princesse Grace
Centre hospitalier Bourg en Bresse
CHMS Chambéry
CHI Poissy - St Germain en Laye
Clinique Saint Léonard
Clinique Bergouignan
Clinique Saint Charles
Hopital privé Sainte Marie
Infirmerie Protestante
Clinique de l'Occitanie


title: An ALFA 2101 Multicenter Randomized Phase II Study: CPX-351 Versus Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics

summary: The trial is a randomized, open-label phase II study comparing CPX-351 vs conventional intensivechemotherapy in patients with newly diagnosed de novo AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria)

lead_sponsor: Centre Hospitalier Universitaire de Nice

collaborators:
Jazz Pharmaceuticals
Acute Leukemia French Association

location_facility: Centre Hospitalier Sud Francilien (CHSF)

location_facility: Groupe hospitalier de la région de Mulhouse et Sud-Alsace, Hôpital Emile Muller

location_facility: Institut d'hématologie de Basse Normandie (IHBN)

location_facility: Centre Hospitalier de Versailles, Site André Mignot


acronym: DIAL

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

summary:
Immunotherapeutic approaches recently have demonstrated clinical efficacy in several cancer types, including melanoma and NSCLC. As a matter of fact, first registration trials of immune-checkpoints inhibitors (ICI) in second-line settings (pembrolizumab as well as nivolumab or atezolizumab) had stated that ICI could be continued until disease progression or not tolerable toxicity, up to 5 years. This is only for the first-line registration studies that the arbitrary maximal duration of treatment of 2 years was set up by the Companies sponsoring such trials.

The aim is to study a de-escalation scheme of treatment from 2 years of immunotherapy to 6 months (27-weeks), in patients with controlled disease.

location_facility: Saint-Nazaire - Clinique Mutualiste de l'Estuaire

location_facility: Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

location_facility: Institut de Cancérologie de l'Ouest - René Gauducheau

title: A Phase II-III Randomized Trial Evaluating Maintenance Pembrolizumab (± Pemetrexed) Until Progression Versus Observation (± Pemetrexed) After 6 Months of Platinum-based Doublet Chemotherapy Plus Pembrolizumab Induction Treatment in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

type: EudraCT Number

source: euctr

ipd_sharing: Yes


title: Evaluation of the Efficacy of Donepezil in the Treatment of Oxaliplatin-induced Peripheral Neuropathy: Proof of Concept Study

acronym: DONEPEZOX

summary:
The use of oxaliplatin in the treatment of colorectal or pancreas cancer induces (>75% of patients) severe sensorimotor neuropathy decreasing the quality of life of cancer survivors. Today, no treatment remains univocal for these peripheral neuropathies. But preclinical works have demonstrated that donepezil (acetylcholinesterase inhibitor use for Alzheimer's disease) was able to prevent and treat neuropathic symptoms in oxaliplatin-treated rats.

Present study aims to assess the therapeutic efficacy of donepezil on oxaliplatin-induced peripheral neuropathy (OIPN) in cancer survivors. Bibliographic data suggests an antineuropathic effect of donepezil in human and animal models. In clinic, a study have shown in healthy volunteers that donepezil (associated with gabapentin) reduced the pain threshold (better than gabapentin alone) caused by stimulation of the sural nerve, without severe adverse effect. Similarly, two studies in patients with neuropathic pain demonstrated that donepezil increases analgesic effect of gabapentin. Finally, a case report demonstrated an analgesic effect of donepezil in painful Alzheimer's disease patients. In animals, several studies demonstrated that donepezil induces analgesic and neuroprotective effects. Recently, a preclinical study demonstrated that donepezil induced antineuropathic effect in diabetic mice with neuropathic pain. Research unit INSERM U1107 (partner of the DONEPEZOX study) demonstrated the antineuropathic effects of donepezil in several animal models of chemotherapy-induced peripheral neuropathies, and very recently, a study have confirmed these results with oxaliplatin and cisplatin. These clinical and preclinical data have thus highlighted the potential beneficial effect of donepezil on neuropathic symptoms, without any significant adverse effects. Therefore the hypothesis is that the use of donepezil could reduce the symptoms of OIPN, limit the decrease in quality of life and the appearance of comorbidities (anxiety/depression) in cancer survivors.

For this purpose, the investigators propose here a proof of concept, multicentre, phase II, randomised, double-blind, placebo-controlled clinical study. The primary objective will be the curative efficacy of donepezil on the severity of OIPN in patients who have completed oxaliplatin-based chemotherapy for the treatment of colorectal or pancreas cancer and have peripheral neuropathy of grade ≥2. This will be assessed using the EORTC QLQ-CIPN20 sensory scale. Our methodological choice to use the QLQ-CIPN20 as the primary endpoint will allow us to more accurately (and in a standardized manner) characterize neuropathic symptoms and assess the therapeutic effect of donepezil on these symptoms. In addition, as secondary objectives, we will study the effect of donepezil on neuropathic pain, the intensity of neuropathic symptoms, health-related quality of life, and the tolerance of donepezil.

The 80 patients required will be randomized (1:1) to receive either placebo or donepezil (5 mg daily for 4 weeks and then 10 mg daily for 12 weeks as a single dose and according to tolerance and efficacy). Patients will be followed for 1 month after the end of treatment to assess the OIPN. As a proof of concept study, responder rate will be assessed only for Donepezil arm (primary objective) and compared between each treatment arm (secondary objective) after a minimum of 12 weeks of treatment. A responder will be defined as a patient with a decrease of neuropathic grade according to CIPN20 sensory score compraed to baseline.

ReferenceType: derived

ReferenceCitation: Kerckhove N, Tougeron D, Lepage C, Pezet D, Le Malicot K, Pelkowski M, Pereira B, Balayssac D. Efficacy of donepezil for the treatment of oxaliplatin-induced peripheral neuropathy: DONEPEZOX, a protocol of a proof of concept, randomised, triple-blinded and multicentre trial. BMC Cancer. 2022 Jul 7;22(1):742. doi: 10.1186/s12885-022-09806-8.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

collaborators: Federation Francophone de Cancerologie Digestive

location_facility: Groupe Hospitalier des Portes de Provence

location_facility: Groupe Hospitalier Saint Vincent - Clinique Saint Anne

location_facility: Institut de Cancérologie de Bourgogne - GRReCC

location_facility: Hôpital d'Instruction des Armées Sainte-Anne


title: Diagnostic Performance of Spot Urine Sample for the Monoclonal Components Detection in Patients With Multiple Myeloma RHU(M)M Random or H24 Urine in (Multiple) Myeloma

acronym: RHUMM

summary: The primary objective of the study is to evaluate at Day 1 Cycle 2, the detection sensitivity of the urinary monoclonal component on a spot urine sample, compared to the reference measurement on 24-hour urine, in patients with Multiple Myeloma.

lead_sponsor: Intergroupe Francophone du Myelome

location_facility: CH Bretagne Atlantique Vannes et Auray-P.Chubert

intervention_type: Diagnostic Test


title: Randomized Phase III Trial in MMR Deficient Endometrial Cancer Patients Comparing Chemotherapy Alone Versus Dostarlimab in First Line Advanced/Metastatic Setting

acronym: DOMENICA

summary: Phase 3, randomized, multicentre study to evaluate the efficacy and safety of dostarlimab versus carboplatin-paclitaxel in patients with MMR deficient relapse or advanced endometrial cancer.

sponsor_collaborators:
ARCAGY/ GINECO GROUP
GlaxoSmithKline

location_country: Singapore France

location_facility: Groupe Hospitalier Diaconesses-Croix Saint-Simon

location_facility: CHU Saint-Etienne - Pôle de Cancérologie

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: Institut de Cancérologie de Strasbourg Europe - ICANS

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Maevad - Mobilisation Active de l'Empan Visuo-Attentionel Pour la Dyslexie

summary: The aim of the study is to evaluate the efficiency of the medical device MAEVAD in improving the reading skills of children with dyslexia.

lead_sponsor: Humans Matter

location_facility:
KALCK Christine
BOCCOGNANI Jordane
REVERSE Christelle
BERTHOLOM Anne-Marine
RAFFIN LETHULLIER Virginie
PELLATON Aurélie
MAZERAN Anne-Cécile
CAMUS-BRUNEAU Anne
RAYNAUD LEGROS Caroline
KOCHEL Jeanne-Marie
BLONDE Manon
LHUILLIER Françoise
VIERLING Pauline
TERRASSON Cécile
HOLLINGSHAUSEN Sophie
LEJOSNE Julie
CAILLY Gautier
RICARD Pauline
CARRIQUE Pascale
KIS Nathalie
CONTESTI Véronique
LADOUL Marine
VALLERY Théoline
RUBINI Diane
BLANC Emilie
BERNARD-DENIS Fabienne
JORDANIS Mélanie
PASQUIER Amélie
DESCENDRE Myriam
AÏT LEMKADEM Mimouna
DE MUYNCK Solène
CHAUVET Clémence
SCHMITT Véronique
COURANT Sabrina
BRESSON Raphaëlle
BOUJU Céline
FLAMMANT Anne-Sophie
CHABERT Claire
BERARD Marine
KOUASSI-PUJOL Marie
CLAVIER-MARCOUX Laetitia
JOIRE Isabelle
CALAIS Cécile
BERTHELOT Florence
DELOUS Thomas
EMERIAU Mathilde
LECLERC LE COADOU Rozenn
LE BOURHIS Aurélie
GOBÉ Valérie
SHAW PERRIN Anne-Sophie
Britt
RIZK Joumana
NADAUD Stéphanie
FRITSCH Colombine
VERLOT-MORY Ludivine
FORTIER Anne
CASTERES Catherine
BIRAN Sandrine
BOIS PARRIAUD Françoise
DE VALENCE Cécile
GUILLERMOND Sandra
LEGENDRE Laure
MARTINELLI Karen
KRAYEM Mona
ZIMMERMAN Amélie
CADALEN Hélène
LEFÈVRE Hélène
VOLUET FROMENT Adeline
PREVOST Adeline
CRABÉ Marion
CARCEY-CADET Elise
MINIAC-FOURNIER Stéphanie


title: A Phase II Randomized, Open-Labelled, Multicenter Study of Safety & Efficacy of Combination Brigatinib and Carboplatin-Pemetrexed Therapy or Brigatinib Monotherapy as First-Line Treatment in Advanced ALK-Positive Non-Small Cell Lung Cancer

summary: This is a phase II randomized, open-labelled, non-comparative multicenter study in which ALK+ NSCLC patients who are naïve of treatment for advanced disease will be randomized to receive brigatinib monotherapy (Arm A) or brigatinib and carboplatin-pemetrexed therapy (Arm B). An estimated 110 patients (55 in Arm A, 55 in Arm B) will be enrolled at approximately 30 centers. A safety phase will evaluate the safety of brigatinib with carboplatin and pemetrexed treatment combination (Arm B). The first twenty-six patients enrolled in Arm B will represent the population of the safety phase. Patients will be treated until they experience progressive disease, intolerable toxicity, or another discontinuation criterion is met. Continuation of brigatinib beyond progression is permitted, at the investigator's discretion, if there is evidence of continued clinical benefit. The null hypothesis is progression free survival at 12 months ≤ 69% for Arm B, which is considered not sufficiently clinically meaningful to warrant further study. The alternative hypothesis is that 86% or more of patients in Arm B would achieve progression free survival at 12 months.

sponsor_collaborators: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Centre Hospitalier de Villefranche-sur-Saône

location_facility: Hospices Civils de Lyon - Hôpital Louis Pradel


title: AGORA-1 /ALFA 2100 Study : A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD Relapse/Refractory (R/R) AML

summary: This is a national, open-label, single-arm, multicenter phase II trial evaluating the safety and efficacy of adding gilteritinib, a new FLT3 inhibitor to the AGORA platform, consisting of the combination of an intermediate dose of cytarabine and a divided dose of GO in adult patients with R / R AML with an FLT3-ITD mutation.

lead_sponsor: Centre Antoine Lacassagne

sponsor_collaborators:
Centre Antoine Lacassagne
Acute Leukemia French Association

location_facility:
Hôpital Avicenne
Centre Léon Bérard
CHU Limoges
Hôpital Lyon sud
Hôpital Necker
CHU d'Amiens
CHR Orléans
CHRU Bretonneau
Hôpital la Timone Conception
CHU d'Angers
CHU Henri Mondor
CHU Dijon
HIA Percy
CHU Robert Debré
IGR
CH Victor Dupouy
CHU Nantes
CHRU Nancy
Centre Hospitalier de Versailles
CHU Pontchaillou
CHU de Caen
Hôpital Saint Louis
CH René Dubos
CH de Meaux
CHU Poitiers
CHU Bordeaux
CHMS de Chambery
Hôpital de la Pitié Salpétrière
Centre Henri Becquerel

intervention_type: Combination Product


title: AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms

acronym: AVAJAK

summary:
Philadelphia-negative myeloproliferative neoplasms (MPN) are frequent and chronic myeloid malignancies including Polycythemia Vera (PV), essential thrombocythemia (ET), Primary Myelofibrosis (PMF) and Prefibrotic myelofibrosis (PreMF). These MPNs are caused by the acquisition of mutations affecting activation/proliferation pathways in hematopoietic stem cells. The principal mutations are JAK2V617F, calreticulin (CALR exon 9) and MPL W515. ET or MFP/PreMF patients who do not carry one of these three mutations are declared as triple-negative (3NEG) cases even if they are real MPN cases.

These diseases are at high risk of thrombo-embolic complications and with high morbidity/mortality. This risk varies from 4 to 30% depending on MPN subtype and mutational status.

In terms of therapy, all patients with MPNs should also take daily low-dose aspirin (LDA) as first antithrombotic drug, which is particularly efficient to reduce arterial but not venous events.

Despite the association of a cytoreductive drug and LDA, thromboses still occur in 5-8% patients/year.

All these situations have been explored in biological or clinical assays. All of them could increase the bleeding risk. We should look at different ways to reduce the thrombotic incidence: Direct Oral Anticoagulants (DOAC)? In the general population, in medical or surgical contexts, DOACs have demonstrated their efficiency to prevent or cure most of the venous or arterial thrombotic events.

At the present time, DOAC can be used in cancer populations according to International Society on Thrombosis and Haemostasis (ISTH) recommendations, except in patients with cancer at high bleeding risk (gastro-intestinal or genito-urinary cancers). Unfortunately, in trials evaluating DOAC in cancer patients, most patients have solid rather than hematologic cancers (generally less than 10% of the patients, mostly lymphoma or myeloma).

In cancer patients, DOAC are also highly efficient to reduce the incidence of thrombosis (-30 to 60%), but patients are exposed to a higher hemorrhagic risk, especially in digestive cancer patients.

In the cancer population, pathophysiology of both thrombotic and hemorrhagic events may be quite different between solid cancers and MPN. If MPN patients are also considered to be cancer patients in many countries, the pathophysiology of thrombosis is quite specific (hyperviscosity, platelet abnormalities, clonality, specific cytokines…) and they are exposed to a lower risk of digestive hemorrhages. It is thus difficult to extend findings from the "general cancer population" to MPN patients.

Unfortunately, only scarce, retrospective data regarding the use of DOAC in MPNs are available data.

We were the first to publish a "real-life" study about the use, the impact, and the risks in this population. In this local retrospective study, 25 patients with MPN were treated with DOAC for a median time of 2.1 years. We observed only one thrombosis (4%) and three major hemorrhages (12%, after trauma or unprepared surgery). Furthermore, we have compared the benefit/risk balance compared to patients treated with LDA without difference.

With the increasing evidences of efficacy and tolerance of DOAC in large cohorts of patients including cancer patients, with their proven efficacy on prevention of both arterial and venous thrombotic events and because of the absence of prospective trial using these drugs in MPN patients, we propose to study their potential benefit as primary thrombotic prevention in MPN.

primary_purpose: Prevention

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility: Institut de Cancérologie Lucien Neuwirth St-Priest-en-Jarez

location_facility: Médipôle Hôpital Mutualiste Villeurbanne

appel_a_projets: PHRCK

region: Bretagne

nom_etablissement: CHRU BREST

acronyme: AVAJAK

titre: Apixaban/rivaroxaban Versus Aspirine en prévention primaire des complications thromboemboliques des néoplasies myéloprolifératives mutées pour JAK2V617F

discipline_principale: cancer

nom_porteur: IANOTTO

prenom_porteur: Jean-Christophe


title: Psychological Trauma and Resilience After ICU Stay in Patients Treated With Mechanical Ventilation for Severe Critical Illness: the Multicenter, Prospective, Observational RESIREA Study

acronym: RESIREA

summary: Critically ill patients experience a severe physical disease, associated with a psychotrauma, which may lead to post-traumatic stress disorder (17 to 30% of patients after critical illness) and persistent symptoms of anxiety and depression. RESIREA study will study psychodrama, resilience and factors associated with resilience in patients previously included in the NUTRIREA-3 randomized controlled trial designed to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding in a well-defined group of severely ill ICU patients requiring at least MV and vasoactive drugs.

lead_sponsor: Nantes University Hospital

location_facility:
CHU Amiens Picardie nord
CH Chartres Louis Pasteur
CHU Gabriel Montpided
CH Angoulême
CHU Amiens Picardie sud
CH du Mans
Hôpital Edouard Herriot
CHU Jean Minjoz
CHRU Bretonneau
CH Dieppe
CHU de Nantes
CH Annecy Genevois
CHU Angers
CHBA - Vannes Auray
CH Argenteuil
CH de Bigorre
CHU de Valenciennes
CHR- Roger Salengro
CH de Béthune
CHD Vendée
APHP - Hôpital Raymond Poincaré
CH de Lens
APHP - Hôpital Cochin


title: Randomized Study of Paclitaxel-carboplatin Followed by Niraparib Compared to Paclitaxel-carboplatin-bevacizumab Followed by Niraparib+Bevacizumab in Patients With Advanced Ovarian Cancer, Following a Front-line Complete Surgery

summary: Randomized, open label, phase II multicenter study to assess the efficacy niraparib versus niraparib +bevacizumab maintenance in patients with newly diagnosed stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery and treatment by adjuvant platinum-basedchemotherapy +/-bevacizumab.

location_country: Japan France

location_facility: ICANS - Institut de cancérologie Strasbourg Europe

location_facility: Groupe Hospitalier Diaconesses - Croix Saint-Simon

location_facility: Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard

location_facility: CHU Grenoble-Alpes - Site Nord (La Tronche)

location_facility: Centre ONCOGARD - Institut de cancérologie du Gard

location_facility: HCL - Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)

location_facility: CHU de Saint-Etienne - Pôle de Cancérologie

location_facility: Sainte Catherine Institut du cancer Avignon-Provence

location_facility: Saitama Medical University International Medical Center


title: A Randomized Phase I/ II Multicenter Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA

summary: Study of the combination of luspatercept in low-risk myelodysplastic syndrom (LR-MDS) without ring sideroblasts (RS) having failed or being ineligible to ESA

lead_sponsor: Groupe Francophone des Myelodysplasies

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Celgene

location_facility: Institut de Cancérologie et d'Hématologie Universitaire de Saint-Etienne


title: Study Among People Living With HIV and Their Health Professionals of Associated Factors of Resilience to Self-stigma

acronym: RESILSTIGMA

summary: This study is perform to study the effect of psychological and psychosocial factors associated with resilience to the self-stigmatization of people living with HIV

collaborators: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

collaborators: Groupe Hospitalier de la Rochelle Ré Aunis

collaborators: Centre Hospitalier Universitaire de Nice

collaborators: L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône

collaborators: Centre Hospitalier Universitaire de Besancon

location_country: Réunion Guadeloupe France

location_facility: Centre Hospitalier Intercommunal de Cornouaille

location_facility: Groupe Hospitalier de La rochelle-Ré-Aunis

location_facility: Hôpital Nord Ouest villefranche sur Saone


title: One Day Implantation Program for Heart Failure Patients Implanted With BIOTRONIK Cardiac Resynchronization Therapy Pacemakers

acronym: OEDIPE-CRT-P

summary: This study has been implemented to evaluate cardiac resynchronization therapy pacemaker (CRT-P) implantations on a same-day basis

lead_sponsor: Biotronik SE & Co. KG

location_facility: GCS Centre de Cardiologie du Pays Basque


title: Point-of-care Regional Anaesthesia in Intensive Care Unit. A Multicentric Professional Practice Evaluation

acronym: Week'ALR

summary:
Pain is a major problem in Intensive Care Unit (ICU). Adequate pain management not only means decreasing the pain intensity, but also improving the functionality and allowing the early mobilization that is a prerequisite for improving recovery and decreasing the risk of complications in ICU. The complex problems involved in pain, analgesic interventions, and outcome have been emphasized in several surveys over the past decades, but apparently with only small improvements, despite the existence of several guidelines for perioperative pain management.

Regional analgesia techniques (peripheral and neuraxial nerve blocks) have the potential to decrease the physiological stress response to trauma or surgery, reducing the possibility of surgical complications and improving the outcomes. Recent studies suggested that surgical and trauma ICU patients receive opioid-hypnotics continuous infusions to prevent pain and agitation that could increase the risk of posttraumatic stress disorder and chronic neuropathic pain symptoms, and chronic opioid use. Also they may reduce the total amount of opioid analgesics necessary to achieve adequate pain control and the development of potentially dangerous side effects. The use of the regional anesthesia technique in the ICU, however, can, in part, be limited by the presence of hemodynamic instability, bleeding diathesis, and by the fear of the performing procedures potentially associated with significant side effects in heavily sedated patients.

Although regional anesthesia emerges as a new and very interesting player for pain management in ICU, today very few data exists about the use of RA (including PNB and neuraxial nerves blocks) by the practicians in ICU/stepdown units. The main objective of this study is to assess the use of RA for pain management both initiates in the operative room for surgical patients then transferred in ICU/stepdown units and performs directly by the practicians in ICU/stepdown units, in several french units.

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Centre Hospitalier Universitaire de Nīmes

location_facility:
HCL Centre des Grands Brulés
AHPH Saint-Antoine
CHU
CH
APHM la Timone
APHM Nord
APHP Bichat
HCL Hôpital Sud
Centre Jean-Perrin


title: Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplant Cyclophosphamide in Patients With Acquired Refractory Aplastic Anemia or in Relapse After Immunosuppression: a Nationwide Phase II Study

acronym: HAPLO-EMPTY

summary:
Outcomes for patients with severe aplastic anemia (SAA) who are refractory to first-line immunosuppressive therapy (IST) and who lack a matched unrelated donor (MUD) remain poor. Recently, the use of eltrombopag (ELT) has shown blood count improvements in 40% of these patients. However, most refractory patients do not respond to ELT or other second-line treatment and are therefore exposed to life-threatening infections, and bleeding. During the past 2 decades, there has been a significant decrease in infection-related mortality in patients with SAA unresponsive to initial IST but clonal evolution including paroxysmal nocturnal hemoglobinuria (PNH), myelodysplastic syndrome (MDS), and acute myeloid leukemia (AML) still occur in the long-term with a grim prognosis. Overall, the overall survival of such patients with acquired refractory SAA to ELT is about 60-70% at 2 years.

Hematopoietic stem cell transplantation (HSCT) using alternative donor sources (i.e., mismatched unrelated donors, cord blood (CBT), and haplo-identical family donors) may be curative in patients with refractory SAA, despite carrying much higher rates of complications than in transplantations from matched related or unrelated donors. Recently, our group showed that CBT is a valuable curative option for young adults with refractory SAA. However, not all patients have available CB and CBT treatment related mortality is high in adult patients. Haploidentical (haplo) related donor Stem Cell Transplantation (haplo-SCT) have improved dramatically outcomes using T-cell replete grafts with administration of post-transplantation cyclophosphamide (PTCy). Preliminary results in a little number of patients with refractory SAA at Kings college (London, UK) and John Hopkins (Baltimore, USA) seem promising. The investigators retrospectively analyzed data from 36 patients (median age 42 years) transplanted between 2010 and 2017 in Europe on behalf of the SAA working party of the European Blood and Marrow Transplantation group. The 1-year overall survival was about 80% suggesting that this approach might be a valid option in this particular poor clinical situation.

The main objective of this study is to demonstrate a benefit in term of the 2-year overall survival rate from 60% (historical rates in patients with acquired refractory idiopathic aplastic anemia) up to 80% using haplo-SCT with PTCy.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Henri Mondor
CHU Lyon Sud
CHU Toulouse
CHU Nice
CHU Rennes
CHU Limoges
IHOP, CHU Lyon
Crlcc Henri Becquerel Rouen
Hôpital du Haut-Lévêque
CHU Amiens
CHRU Strasbourg
Hopital Necker
Hopital Percy
CHU Nancy
CHU Angers
CHU Nantes
CHU Montpellier
CHU Caen
CHU-Estaing_Clermont Ferrand
Hopital La Timone
CHU Grenoble
Hôpital Saint Antoine
Hôpital Saint Louis
CHU Besancon
ICLN_Saint Priest En Jarez
CHU Poitiers
CHU Bordeaux
CHU Lille
Hopital Robert Debré
Hôpital de La Pitié Salpetriere
CHU Clermont

acronyme: HAPLO-EMPTY

titre: Allogreffe haplo-identique avec injection de cyclophosphamide post-greffe chez des patients présentant une aplasie médullaire idiopathique réfractaire à un traitement immunosupresseur : étude nationale de phase II

discipline_principale: hématologie / vigilance et thérapeutique transfusionnelles

nom_porteur: PEFFAULT DE LATOUR

prenom_porteur: Régis


title: Loco-regional Anaesthesia in Video or Robot-assisted Thoracic Pulmonary Surgery

acronym: ARTIST

summary:
Currently, there is no data on the part and type of Loco-regional Anaesthesia used for Video or Robot-assisted Thoracic Pulmonary Surgery.

The aim of this epidemiological study is to identify, 6 months after the publication of the SFAR / SFCTCV 2019 recommendations, the proportion and type of Loco-regional Anaesthesia used in Video or Robot-assisted Thoracic Pulmonary Surgery within French teams.

sponsor_collaborators: Société Française d'Anesthésie et de Réanimation

location_facility: CHRU de Lille _Clinique Cardiothoracique et Vasculaire

location_facility: centre de Lutte Contre le Cancer Jean Perrin

location_facility: Clinique de l'Infirmerie Protestante de Lyon


title: Biological Characterization of Advanced ALK-rearranged Non-small Cell Lung (NSCLC) Cancer Included in EXPLOREALK Study

acronym: BIOEXALK

summary:
BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with next generation TKIs in first line, included in the national EXPLORE ALK cohort (GFPC 03-2019), a non-interventional, national, multi-center cohort of ALK-rearranged NSCLC patients.

BioExALK study will be proposed to every patient included in the Explore ALK GFPC 03-2019 study.

Biological analysis will be performed on tumor tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA (ctDNA).

For plasma testing, after obtained patient consent, blood samples will be taken and analyzed at the Léon Bérard Center (Lyon).

Biological analysis on tissue obtained at diagnosis and at disease progression will be collected and be sent for centralized analysis to the Rouen University Hospital.

primary_purpose: Basic Science

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

sponsor_collaborators:
Groupe Francais De Pneumo-Cancerologie
Takeda

location_facility: Centre Hospitalier de Villefranche sur Saone

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Hôpital d'Instruction des Armées Ste Anne

location_facility: Oncologie Institut du Cancer de Montpellier

intervention_type: Genetic


title: Observatory of Patients With Haemophilia B Treated by IdElvion®

acronym: OrPHEe

summary: OrPHEe is a non-interventional, prospective and national study which aim is to record real life data in haemophilia B French patients treated with Idelvion® to confirm the efficacy and safety of this product established in clinical development studies.

lead_sponsor: CSL Behring

location_facility:
CHRU Brest
CHU Toulouse
CRC-MHC Hôpital Kremlin Bicêtre
CHU Nice
CHU Rennes
CH du Mans
Hôpital Edouard Herriot
CHU Tours
CHU Saint-Etienne
CHRU Strasbourg
CHU Dijon
CHRU Besançon
CHU Rouen
CH Annecy Genevois
CHU Bordeaux - Hôpital Pellegrin
CHU Nantes
CHU Montpellier
CHU de Reims
CHRU Nancy
CHU Clermont-Ferrand
CHRU Lille
CHU de Grenoble
Hôpital André Mignot - CH Versailles
CHU Caen
CHU de Limoges
Hôpital Simone Veil
Hôpital Necker Enfants Malades
CHU Amiens - Picardie


title: Randomized Phase III Trial of Standard Immunotherapy (IO) by Checkpoint Inhibitors, Versus Reduced Dose Intensity of IO in Patients With Metastatic Cancer in Response After 6 Months of Standard IO

acronym: MOIO

summary: Immunotherapy (IO), such as treatment with anti-PD-1, PD-L1, or CTLA-4 inhibitors, is a rapidly expanding treatment for multiple metastatic cancers with improved survival for certain cancers. However, the optimal duration of immunotherapies is currently unknown. Our hypothesis is that a reduced dose intensity of IO could be as effective as the current standard treatment in term of prevention of the disease progression. If proved right, this study will have a positive medico-economic impact by reduction of the costs associated with the treatment and the toxicity, and an increase of the patients' quality of life.

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

lead_sponsor: UNICANCER

location_facility:
Hôpital Européen Georges Pompidou
IUCT
Clinique Chenieux
Institut Curie
Clinique Sainte Catherine
Centre Hospitalier de la Côte Basque
ICANS
Centre Eugene Marquis
Hôpital Pitié Salpêtrière
Institut de cancérologie de l'Ouest
Centre Hospitalier Intercommunal
CHU Henri Mondor
Hôpital La Timone -APHM
Centre Georges François Leclerc
Centre Jean Perrin
Centre Antoine Lacassagne
Centre François Baclesse
Hôpital Saint Louis
Hôpital Foch
CHU Besançon
Insitut Godinot
Hospices Civils de Lyon
CHU Poitiers
CHU Bretonneau


title: Three Weeks Versus Six Weeks Antibiotic Therapy for Nonsurgically Treated Diabetic Foot Osteomyelitis : a Multicenter, Randomized, Open-label and Controlled Study

summary: The aim of this clinical study is to compare the efficacy and tolerance of 3 versus 6 weeks of antibiotherapy in patients with diabetic foot osteomyelitis treated medically.

lead_sponsor: Tourcoing Hospital

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hopitalier Universitaire de Brest

location_facility: Centre Hospitalier Universitaire de Lille


title: Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor

acronym: RETRO-CBF

summary:
Acute Core Binding Factor leukemias represent a specific category of acute myeloid leukemias that share prognostic factors, a specific mutational profile, and a favorable response to chemotherapy. Their management now follows the reference pattern from the French trial CBF-2006 closed to inclusions since November 2010. This includes intensive chemotherapy and intensification by allogeneic marrow transplant depending on the residual disease measured by RT qPCR . These leukemias have not been the subject of multicenter clinical trials since that date.

The results of this treatment regimen need to be evaluated. Known prognostic factors such as signaling mutations, clonal interference or residual disease follow-up (MRD) will be analyzed and updated in this recent cohort. The interaction between residual disease and mutational profile will be evaluated on the prognosis. Treatment with gemtuzumab-ozogamycin and first-line allogeneic transplantation will be investigated, depending on prognostic factors including associated mutations and residual disease. The course and early treatment of molecular relapses will be analyzed. The treatment and prognosis of cytological relapses will be described with in particular the role of tyrosine kinase inhibitors and therapeutic intensification.

status: Unknown status

lead_sponsor: Acute Leukemia French Association

location_facility: Centre Hospitalier de Versailles André Mignot

status_simplified: Unknown


title: Study of the Criteria for Choosing Speedicath Catheters During the Initiation of Self-catheterization

acronym: Eva

summary: To date, there is no objective data to help in the choice of the type of catheter to offer to the patient according to his or her needs. Although it is now known that the quality of life of patients practicing intermittent self catheterisation is dependent on multiple factors, there is little data on the factors that facilitate or hinder adherence to intermittent self catheterisation during the first six months after initiation of intermittent self catheterisation. The prospective multicenter exploratory observational study that the sponsor wishes to conduct aims to determine what criteria preside over patient choice of SpeedyCath (SC) leads. This information would allow us to set up a personalized advice with each patient in the future, with the aim of proposing the SC catheter best adapted to his needs. The study population will consist of adults with neurogenic or non-neurogenic urinary disorders that warrant the use of intermittent self catheterisation, with intermittent self catheterisation education occurring at the time of inclusion. Patients should be autonomous in the practice of intermittent self catheterisation, and the minimum expected duration of follow-up should be greater than or equal to 6 months. Only patients who choose to use SpeediCath leads will be included in the study.

lead_sponsor: Laboratoires Coloplast S.A.S

location_facility: Centre Hospitalier Intercommunal Robert Ballanger

location_facility: Institut Mutualiste Montpelliérain- Beau soleil


title: Validation d'Une Solution Digitale intégrée (SUNrise®) d'Analyse Automatique Des Mouvements Mandibulaires Par Intelligence Artificielle Versus Polysomnographie Pour le Diagnostic du Syndrome d'Apnées Obstructives du Sommeil

acronym: SUNSAS

summary: Validation of an integrated digital solution (SUNrise®) of mandibular movement automatic analysis by artificial intelligence versus polysomnography for obstructive sleep apnea diagnosis: a prospective, randomized, parallel-arm, open-label, multicenter, national, controlled study.

status: Active, not recruiting

primary_purpose: Diagnostic

lead_sponsor: Sunrise

sponsor_collaborators: Sunrise ICUREsearch

location_facility: CHU Montpellier - Hôpital Gui-de-Chauliac

location_facility: CHRU de Nancy - Hôpital d'Adultes de Brabois

location_facility: Hôpitaux Universitaires de Paris Seine Saint-Denis (HUPSSD, AP-HP),


title: Observational Prospective Study of Quality of Life in Unresectable TNM Stage III NSCLC (OBSTINATE)

acronym: OBSTINATE

summary:
OBSTINATE is an observational, national, prospective, multicentric study on Quality of life in patients with unresecable stade III non-small cell lung cancers.

Locally advanced non-small cell lung cancers (NSCLCs with a Tumor, Node and Metastasis [TNM] stage III) patients represent approximately a third of newly discovered NSCLCs every year, and a very heterogeneous group of clinical situations. Therapies are multidisciplinary and very heterogeneous across oncology centers. Patients with locally advanced NSCLC have a high symptom burden that is known to affect their quality of life. Health-related quality of life (HR-QoL) is a specific and multidimensional type of patient-reported outcome (PRO) related to the physical, psychological and social impact of the disease and its treatment as perceived by patients. HR-QoL allows, together with data of efficacy and safety, a more complete assessment of risks and benefits of each treatment. Therefore, QoL maintenance is a valuable consideration for treatment decisions, especially in the rapidly evolving therapeutic landscape of unresectable NSCLC.

The study is designed to collect PROs HR-QoL data from every new patient diagnosed with an unresectable stage III NSCLC over a period of 18 months. We also aim to describe clinical characteristics of these patients, the therapeutic strategies conducted, and outcomes in a "real-word" oncological practice.

sponsor_collaborators:
Groupe Francais De Pneumo-Cancerologie
AstraZeneca

location_facility: Centre Hospitalier de Villefranche sur Saone

location_facility: Centre Hospitalier Universitaire DUPUYTREN

location_facility: Centre Hospitalier Intercommunal de Quimper

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre Hospitalier d'Elbeuf - Pneumologie


acronym: InTTercePT

summary:
The overall survival of patients with metastatic breast cancer has steadily improved over the past decades, mainly due to advances in systemic treatment. Despite these advances, the development of brain metastases remains a serious and devastating complication that decreases quality of life and increases morbidity and mortality. The HER2CLIMB randomized study demonstrated that adding the investigational drug tucatinib to the standard treatment trastuzumab and capecitabine improved both progression-free survival and overall survival in people diagnosed with human epidermal growth factor 2 (HER2)-positive metastatic breast cancer, previously treated with trastuzumab, pertuzumab, and T-DM1. In patients with brain metastases, the 1-year progression-free survival was 25% in the tucatinib group and 0% in the placebo group.

These results suggest that tucatinib may be a new standard treatment for HER2-positive metastatic disease.

The aim of the non-randomized phase II study, InTTercePT, is to evaluate the effectiveness of adding tucatinib to trastuzumab and pertuzumab in the event of cerebral progression, after the end of local treatment.

sponsor_collaborators:
UNICANCER
Seagen Inc.
ARCAGY/ GINECO GROUP

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Institut de Cancérologie de l'Ouest - Site Paul Papin

location_facility: Institut Universitaire de Cancérologie AP-HP. Sorbonne Université, Hôpital Tenon

location_facility: Groupe Hospitalier les Diaconesses Croix Saint Simon

location_facility: CARIO - Centre Armoricain Radiothérapie Imagerie Médicale et Oncologi

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Centre de Cancerologie du Grand Montpellier

location_facility: Centre Hospitalier Universitaire de Besancon

title: Treatment With Tucatinib in Addition to Pertuzumab and Trastuzumab in Patients With HER2-positive Metastatic Breast Cancer After Local Therapy of Isolated Brain Progression

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

collaborators:
Seagen Inc.
ARCAGY/ GINECO GROUP


title: A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myeloma at First Relapse."

summary:
This is a phase II, multicenter, open-label study to evaluate the rate of patients achieving very good partial response (VGPR) or better to the oral combination Iberdomide Ixazomib Dexamethasone in elderly patients with multiple myeloma at first relapse .

The patient population will consist of adult men and women more than 70 years, who meet eligibility criteria.

Following the screening period, patients will be enrolled and treated then, they will receive therapy with Iberdomide, Ixazomib and Dexaméthasone during 6 cycles and Iberdomide and Ixazomib until progression.

location_facility:
CHRU Hopital Haut Lévêque
CHD les Oudairies
CH Lyon Sud
Hôpital Cochin
CHU
ICANS
Hopital de l'archet
CHRU Bretonneau
CHU de Brest
CHRU
CHRU Lille
CHU Henri Mondor
CHR
Hopital St Antoine
CH de la cote basque
University Hospital


title: A Phase II Study of CPX-351 Monotherapy in Acute Myeloid Leukemia

acronym: CPX-351 TA-SMP

summary:
The three classic myeloproliferative neoplasms (MPNs) include polycythemia Vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF). The natural history of these MPNs is the possible progression to acute myeloid leukemia (MPN-blast phase) at variable percentage depending the entity. Leukemic transformation of MPN occurs in 8% to 23% of primary myelofibrosis (PMF) patients in the first 10 years after diagnosis and in 4% to 8% of polycythemia vera (PV) and essential thrombocytosis (ET) patients within 18 years after diagnosis. The risk for leukemic transformation is increased by exposure to cytotoxic chemotherapy. The molecular pathogenesis of MPN-blast phase remains an area of active research.

The prognosis of blast phase MPNs is very poor : approximately 50% of the patients are deemed eligible for intensive treatment (ie. conventional induction chemotherapy regimen with anthracyclines and cytarabine). The patients who are not fit for such intensive treatment approach due to age or comorbidities, are treated with Hypomethylating agents, low dose palliative chemotherapy, or supportive care. Nevertheless, there is a need for more effective and better tolerated treatment approaches in order to increase the response rate and hence, the transplant rates which should translate into improved survival.

CPX-351 is a new formulation of cytarabine and daunorubicin encapsulated at a fixed 5:1 molar-ratio in liposomes that exploits molar ratio-dependent drug-drug synergy to enhance antileukemic efficacy.

Based on similarities between post-myelodysplastic syndrome (MDS) and post-MPN secondary AML in terms of disease resistance to chemotherapy, of fragile patient profile, The hypotheses made is that CPX-351 may improve the results of induction chemotherapy without increasing its toxicity and therefore may increase the proportion of patients who could benefit from an allogeneic Stem Cell Transplantation (SCT).

ReferenceCitation: Courtier F, Carbuccia N, Garnier S, Guille A, Adelaide J, Cervera N, Gelsi-Boyer V, Mozziconacci MJ, Rey J, Vey N, Chaffanet M, Birnbaum D, Murati A. Genomic analysis of myeloproliferative neoplasms in chronic and acute phases. Haematologica. 2017 Jan;102(1):e11-e14. doi: 10.3324/haematol.2016.152363. Epub 2016 Oct 14. No abstract available.

ReferenceCitation: Luque Paz D, Jouanneau-Courville R, Riou J, et al. Leukemic evolution of polycythemia vera and essential thrombocythemia: genomic profiles predict time to transformation. Blood Adv. 2020;4(19):4887-4897. Blood Adv. 2020 Nov 24;4(22):5651. doi: 10.1182/bloodadvances.2020003711. No abstract available.

lead_sponsor: French Innovative Leukemia Organisation

collaborators: French Intergroup of Myeloproliferative syndromes

location_facility: NANTES - Hôpital Hôtel Dieu - Hématologie Clinique

location_facility: BAYONNE - CH de la Côte Basque - Hématologie

location_facility: RENNES - Hôpital Pontchaillou - Hématologie

location_facility: CLAMART - Hôpital d'Instruction des Armées de Percy

location_facility: Toulouse - IUCT Oncopole - Service d'Hématologie

location_facility: POITIERS - Hôpital La Milétrie - Hématologie Clinique

location_facility: MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique

location_facility: REIMS - Hôpital Robert Debré - Hématologie Clinique


title: STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP

acronym: Deeper

summary:
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can dramatically affect the quality of life of patients. Due to its transmural nature (involvement of the entire thickness of the intestinal wall), it naturally progresses to intestinal destruction (stenosis, fistula) which requires intestinal resection in approximately half of patients during their follow-up. The long-term goal for patients is to maintain a normal life, that is, without symptoms and without intestinal destruction. For this, the short and medium term therapeutic objectives have evolved in recent years. Clinical remission is not a sufficient goal since it has failed to alter the natural history of the disease. The current objective to be achieved is the combination of clinical remission and endoscopic mucosal healing since it is associated with a reduced risk of progression (reappearance of symptoms, hospitalization, intestinal resection). Fecal calprotectin, better accepted than colonoscopy, is a non-invasive biomarker of endoscopic inflammatory activity in CD. The CALM study recently showed that close follow-up with clinical and biological evaluation (assays of CRP and fecal calprotectin), called "tight control", associated with therapeutic intensification in the absence of clinical or biological remission, was associated with a better rate of endoscopic mucosal healing at 1 year than follow-up based solely on symptoms. Thus, the "CALM" strategy is considered to be the current benchmark.

Transmural healing evaluated by MRI is also a promising objective associated with a reduced risk of progression (reappearance of symptoms, hospitalization, bowel resection). In addition, it could prevent intestinal destruction. A recent study by our team suggested that calprotectin (mucosal assessment) and MRI (transmural assessment) may be complementary and be a better therapeutic goal. We hypothesize that a "CALM + MRI" strategy concomitantly targeting transmural healing would be superior to the "CALM" strategy alone in maintaining clinical remission without corticosteroids in patients with CD treated with biotherapies.

location_facility:
Issoire Hospital
Clermont-Ferrand University hospital
Saint Etienne University Hospital
Montpellier University hospital
Nice University hospital
Lyon Hospital, Hospices civils de Lyon
Thiers Hospital
Bayonne hospital
Grenoble University Hospital
Chambery Hospital
Rennes University Hospital
Bordeaux university hospital
Nancy University hospital
Aurillac Hospital
Amiens university hospital
LILLE university hospital
Montluçon Hospital

intervention_type: Radiation


title: A Phase II Randomized Study to Assess the Efficacy on Outcome of Venetoclax Combined With Cytarabine Versus Idarubicin Combined With Cytarabine Administered as Post-remission Therapy to Elderly Patients With Acute Myeloid Leukemia in First Remission

summary:
For the FILO group, the standard of care for induction chemotherapy of elderly fit patients with AML is represented by the combination of Cytarabine, Idarubicin and Lomustine. The superiority of this combination was confirmed in a larger prospective study the LAMSA-2007. This induction treatment, followed by six courses of consolidation (Idarubicin and Cytarabine) followed then by a period of 6-month maintenance therapy, allows up to 80 % of remission, and a RFS of 46 % at 2 years.

The aim of the study is to assess the efficacy on outcome of Venetoclax combined with Cytarabine versus Idarubicin combined with Cytarabine administered as post-remission therapy to elderly patients with acute myeloid leukemia in first complete remission (CR) following induction chemotherapy.

location_facility: ANNECY - Centre Hospitalier Annecy-Genevois

location_facility: MULHOUSE - Hôpital E. Muller - Hématologie

location_facility: BEZIERS - Centre Hospitalier - Hématologie

location_facility: PERPIGNAN - CH St Jean - Hématologie Clinique

location_facility: BESANCON - Hôpital Jean Minjoz - Hématologie

location_facility: ST ETIENNE - CHU et Institut De Cancérologie Lucien Neuwirth


title: STop and Restart Acalabrutinib In fRail Patients With Previously Untreated Chronic Lymphocytic Leukemia

acronym: STAIR

summary:
The irreversible Bruton's Tyrosine Kinase (BTK) inhibitor acalabrutinib (ACA) has potent clinical activity as a single agent in patients with treatment naive and Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL).

However, a growing body of concerns is raising regarding the unlimited administration of targeted therapy as BTKi. First, long-term treatments expose the patients to increased risk of specific adverse events (infections, bleeding events or cardiovascular problems). Second, continuous administration might also increase the risk of clonal evolution and therapeutic resistance resulting from genetic alterations such as BTK or PLCG2 mutations. Discontinuation of therapy after a fixed period is expected to prevent these events.

Rapid and deep responses yielded by ACA in elderly patients pave the way of investigating a limited 18-months period schedule. This study aims to investigate the 1-year PFS upon ACA discontinuation and efficacy of restarting ACA upon symptomatic relapse.

location_facility: Institut Paoli-Calmettes - Hématologie Clinique

location_facility: CHU Pontchaillou - Hématologie Clinique BMT-HC

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: CHU Estaing - Hématologie Clinique Adulte

location_facility: Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

location_facility: ARGENTEUIL - Centre hospitalier Victor Dupouy

location_facility: Hôpital Saint-Eloi - Hématologie Clinique

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Hopital Pitie Salpetriere Service Hematologie Clinique - Pavillon de L'Enfant Et Adolescent

location_facility: Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

location_facility: Centre Henri Becquerel - Service Hématologie Clinique

location_facility: CERGY-PONTOISE - Centre Hospitalier René Dubos

location_facility: CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique


title: Impact of a Decision-making Tool to Guide the Use of Physical Restraints in Intensive Care Unit Patients. A Multicentre Randomized Stepped-wedge Trial.

acronym: ARBORéa

summary:
The use of physical restraints is common practice in Intensive Care Units (ICU). This medically prescribed procedure requires full attention of medical and paramedical teams for its implementation, monitoring and ending, as a major restriction of patients' individual freedom. French highest authority for health has defined, for geriatrics and psychiatric units, ten criteria of good practice for physical restraints' use. Routine practice reports critically ill patients' safety as main reason of use. This decision, often left to the sole discretion of nurses, varies according to their own representation of this risk, and depends on several factors: seniority in ICU, nurse to patient ratio and personal workload.

In order to reduce practices subjectivity and heterogeneity, we have developed a decision-making tool for physical restraints implementation. This tool is based on objective scales used on a daily basis concerning neurological status (Richmond Agitation-Sedation Scale (RASS) and Confusion Assessment Method for the ICU (CAM-ICU)). Disorientation or delirium can lead to severe incidents by promoting accidental removing of important devices such as arterial of venous line, drains among others. However, physical restraints are recognized as a major cause of delirium and agitation.

Critically ill patients require rigorous evaluation of organ dysfunctions necessitating adequate invasive equipments, with associated risks of unexpected removal or alteration. Such events could urge caregivers to use physical restraints. Based on recent literature, about a third of ICU patients are restrained, and accidental deconditioning is mainly observed within these particular patients.

In addition, three categories of patients have been defined according to the invasive nature of their equipment and therefore according to the risk associated with an unexpected withdrawal. Finally, presence of patient's family and their adherence to its surveillance were also implemented into the tool. Main study objective is to jointly investigate effectiveness and tolerance of a decision-making tool guiding physical restraints use in ICU patients.

ipd_sharing_description: Individual participant data will be shared upon reasonable request, and after steering committee deliberation.

location_facility: Centre de Lutte Contre le Cancer Jean-Perrin

location_facility: Assistance Publique-Hôpitaux de Marseille - Hôpital Nord

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Assistance Publique-Hôpitaux de Marseille - La Timone

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Centre Hospitalier Universitaire - Hospices Civils de Lyon - Hôpital Edouard Herriot

appel_a_projets: PHRIP

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE CLERMONT-FERRAND

type_etablissement: CH

acronyme: ARBORea

titre: Étude de l'impact de l'utilisation d'un outil d'aide à la décision de contention mécanique des patients hospitalisés en réanimation. Essai multicentrique randomisé en stepped-wedge.

discipline_principale: anesthésiologie / réanimation

nom_porteur: VIDAL

prenom_porteur: Périne


title: Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19

summary:
As of March 2020, COVID-19 has become a global pandemic, halting athletic competition worldwide.

Reports from China show a high prevalence of cardiac involvement in patients with severe SARS-CoV-2 infection. These cardiac forms were found to be closely associated with adverse outcomes. The use of Magnetic resonance Imaging (MRI) had allowed to show that cardiac dysfunction could be mediated by myocardial inflammation (i.e. myocarditis). The direct implication of the virus was demonstrated with Severe Acute Respiratory Syndrome (SARS)-CoV-2 being detected on myocardial biopsies in a patient with severe heart failure.

The experience with other viruses causing acute myocarditis shows that there is a high rate of undetected injuries. Indeed, although severe heart failure can be present at the acute stage, acute viral myocarditis is most commonly pauci or asymptomatic, but still leaving occult myocardial scars visible on MRI, and exposing to higher risks of ventricular arrhythmia and sudden cardiac death over the long term.

Although athletes are younger and have fewer comorbidities than the general population and therefore are at lower risk for severe disease or death, there is a critical and urgent need to assess the prevalence of occult scars in the population of high-level athletes returning to training after the SARS-CoV-2 pandemia.

ReferenceCitation: Chevalier L, Cochet H, Mahida S, S SB, Benard A, Cariou T, Sridi-Cheniti S, Benhenda S, Doutreleau S, Cade S, Guerard S, Guy JM, Trimoulet P, Picard S, Dusfour B, Pouzet A, Roseng S, Franchi M, Jais P, Pellegrin I; ASCCOVID Investigators. Resuming Training in High-Level Athletes After Mild COVID-19 Infection: A Multicenter Prospective Study (ASCCOVID-19). Sports Med Open. 2022 Jun 25;8(1):83. doi: 10.1186/s40798-022-00469-0.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

lead_sponsor: University Hospital, Bordeaux

location_facility: Biarritz Olympique Pays Basque training center

location_facility: Training center Valence Romans Drôme Rugby

location_facility: Bordeaux University Hospital - Service UDH - Hôpital Pellegrin

location_facility: Aviron Bayonnais Rugby Pro Training Center

location_facility: Training center Soyaux Angoulême XV Rugby

location_facility: Union Sportive Colomiers Rugby training center

location_facility: Bordeaux University Hospital - CRB medical office - Hôpital du Tondu


title: Marqueurs Pronostiques et prédictifs de réponse Aux Traitements Chez Les Patients Atteints de Cancer Des Voies Biliaires : Cohorte Multicentrique ACABi PRONOBIL

summary: The objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy, targeted therapy,loco-regional treatments ) in patients with bile duct cancer. The effectiveness and tolerance of these treatments in current practice will also be evaluated.

time_perspective: Other

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Hôpital Avicenne
Hôpital Ambroise Paré
CHU Saint Eloi Montpellier
Centre Léon Bérard
Institut Mutualiste Montsouris
CHU - Henri Mondor
Hôpital Edouard Herriot
CHU Rouen Charles Nicolle
CHU Tours
Centre Eugène Marquis
CHU Rangueil
Institut Curie
CHR Orléans
CHU Dijon
Hôpital Privé Jean Mermoz
Institut Gustave Roussy
Hôpital Croix Rousse
CHU Angers
CHU Nantes
Hôpital Robert Debré -CHU Reims
Institut Paoli Calmette
Hôpital Cochin
Centre Antoine Lacassagne
CHU Saint Etienne
CHRU Nancy Site Brabois
Groupe Hospitalier Pitié Salpêtrière
CHU Grenoble
Hôpital Saint Antoine
Hôpital Saint Louis
CHU Besançon
CHU Poitiers
Hôpital Haut Lévêque
CHU Lille
CHU Hôpital Sud Amiens


title: Real Life Prospective Multicentric Study Evaluating the Clinical and Organisational Impact of Moovcare® Lung Connected Medical Device in Lung Cancer Patients : REAL-MOOV-LUNG

acronym: REAL-MOOV-LUNG

summary: Evaluation of patient's proportion, whose management care has been modified at least once and specially by Moovcare® Lung application at 12 and 24 months.

ipd_sharing_description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

lead_sponsor: Institut Curie

location_facility: Polyclinique de Limoges - Site de François CHENIEUX


title: MInimal Residual Disease Adapted Strategy: Frontline Therapy for Patients Eligible for Autologous Stem Cell Transplantation Less Than 66 Years; a Prospective Study

acronym: MIDAS

summary: IFM 2020-02 will enroll patients eligible for ASCT less than 66 years. All patients will receive induction based on 6 cycles (28-day) of KRD-Isatuximab (Isa-KRD), in order to achieve deep responses and high MRD negativity rates. Patients will be classified at diagnosis according to cytogenetics (standard vs high-risk cytogenetics defined by the LP score including 17p deletion, t(4;14), del(1p32), gain 1q, trisomy 21 and trisomy 5).

ReferenceCitation: Mohan M, Gundarlapalli S, Szabo A, Yarlagadda N, Kakadia S, Konda M, Jillella A, Fnu A, Ogunsesan Y, Yarlagadda L, Thalambedu N, Munawar H, Graziutti M, Al Hadidi S, Alapat D, Thanendrarajan S, Zangari M, van Rhee F, Schinke C. Tandem autologous stem cell transplantation in patients with persistent bone marrow minimal residual disease after first transplantation in multiple myeloma. Am J Hematol. 2022 Jun 1;97(6):E195-E198. doi: 10.1002/ajh.26530. Epub 2022 Mar 21. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

lead_sponsor: Intergroupe Francophone du Myelome

collaborators:
Amgen
Sanofi
Bristol-Myers Squibb

sponsor_collaborators:
Intergroupe Francophone du Myelome
Amgen
Sanofi
Bristol-Myers Squibb

location_facility: CHU Poitiers - Pôle régional de Cancérologie

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: CHRU Hôpital Haut Lévêque - Centre François Magendie

location_facility: Centre Hospitalier Intercommunal de Cornouaille

location_facility: CHV André Mignot - Université de Versailles

location_facility: Centre Hospitalier d'Argenteuil Victor Dupouy

location_facility: Centre Hospitalier Universitaire (CHU) de Limoges

location_facility: CHRU - Hôpital du Haut Lévêque - Centre François Magendie


title: Constitution and Analysis of a Cohort of Patients Followed in Pain Clinics and at Home in Real Life

acronym: e-DOL cohort

summary:
Chronic pain affects approximately 20% of adults, 50% of the elderly population and over 1.5 billion people worldwide. Societal and economic issues are also crucial, as 60% of people with pain are less able or unable to work and 20% say they have lost their jobs because of pain. The overall cost of chronic pain is estimated at around 300 billion euros in the EU. Unfortunately, current treatments for chronic pain have limited effectiveness and important adverse effects. Pain clinics, which support the most complex and refractory cases of chronic pain, as well as general practitioners and patients expect improvements, both in terms of therapeutic efficacy and organization of care.

In order to allow the characterization and a personalized follow-up of chronic pain patients, we have created e-DOL, a smartphone application for patients and a web platform for healthcare professionals in pain clinics. The purpose of this study is to create an e-cohort for the research, and characterization and follow-up of chronic pain patients.

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Institut ANALGESIA

location_facility: CHU de Clermont-Ferrand - Service de Neurologie


title: An Observational National Pediatric Study on Prevalence of Unexplained Splenomegaly

acronym: OPPUS

summary:
Primary Objective:

To assess prevalence of Gaucher disease (GD) diagnosed in pediatric patients presenting with unexplained splenomegaly (SMG) after exclusion of first intention-diagnoses (e.g. portal hypertension, haematological malignancy, hemolytic anemia, infection) based on clinical examination and routine biological tests (full blood count, reticulocytes, liver tests, abdominal ultrasound, Coombs test and Epstein Barr virus serology).

Secondary Objectives:

To describe the rate of each identified disease category and the rate of patients with no final diagnosis at the end of the study in pediatric patients with unexplained SMG after exclusion of first intention diagnoses
To describe the characteristics (clinical, lab, genetics) of all pediatric patients included in the study and to describe the characteristics subdivided by identified disease category and absence of final diagnosis at the end of the study

time_perspective: Cross-Sectional

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi

location_facility:
Investigational Site Number 2500036
Investigational Site Number 2500022
Investigational Site Number 2500010
Investigational Site Number 2500034
Investigational Site Number 2500020
Investigational Site Number 2500023
Investigational Site Number 2500040
Investigational Site Number 2500012
Investigational Site Number 2500019
Investigational Site Number 2500037
Investigational Site Number 2500002
Investigational Site Number 2500026
Investigational Site Number 2500008
Investigational Site Number 2500024
Investigational Site Number 2500021
Investigational Site Number 2500025
Investigational Site Number 2500027
Investigational Site Number 2500013
Investigational Site Number 2500005
Investigational Site Number 2500001
Investigational Site Number 2500028
Investigational Site Number 2500030
Investigational Site Number 2500009
Investigational Site Number 2500029
Investigational Site Number 2500011
Investigational Site Number 2500004
Investigational Site Number 2500017
Investigational Site Number 2500016
Investigational Site Number 2500007
Investigational Site Number 2500014
Investigational Site Number 2500031
Investigational Site Number 2500039
Investigational Site Number 2500006
Investigational Site Number 2500038
Investigational Site Number 2500035
Investigational Site Number 2500032
Investigational Site Number 2500018
Investigational Site Number 2500003
Investigational Site Number 2500015
Investigational Site Number 2500033


title: Phase 2, Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults Unfit for Intensive Chemotherapy With Relapsed or Refractory Acute Myeloid Leukemia or HR-MDS .

summary: To assess the efficacy, and safety of BST-236 in patients unfit for intensive chemotherapy with AML or HR MDS that failed or relapsed following first line therapy

lead_sponsor: Groupe Francophone des Myelodysplasies


title: Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.

summary: Sequential comparative prospective interventional study evaluating the impact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care. Comparison between a first period, period (A), of care as usual and a second period, period (B), of systematic and iterative use of a device for optimizing the decision to continue an anti-cancer treatment.

primary_purpose: Supportive Care

location_facility:
Centre Léon Bérard
CH Intercommunal de Créteil
AP-HP Bichat
CH du Pays d'Aix
CHU Grenoble Alpes
CH Saint-Malo
CGFL
Institut Curie
CHU Amiens - Hôpital Sud
CH Henri Duffaut Avignon
AP-HP Tenon
AP-HP Cochin
CHU Angers
Institut Sainte-Catherine
CHU Sud Francilien
CHRU Lille
Clinique Tessier
CHR Metz-Thionville - Hôpital de Mercy
Clinique des Cèdres
Hôpital Foch
CHD Vendée
CH Abbeville
CHI de Compiègne-Noyon
AP-HP Ambroise Paré

nom_etablissement: CLCC  INSTITUT CURIE

type_etablissement: CLCC

titre: Impact d'un dispositif d'optimisation de la décision de poursuite ou d'arrêt de traitements anticancéreux chez les patients atteints d'un cancer bronchique non à petites cellules avancé.

nom_porteur: MASSIANI

prenom_porteur: Marie-Ange


title: Frequency of SOD1 and C9orf72 Gene Mutations in French ALS

acronym: GENIALS

summary: The purpose of the study is to determine the frequency of mutations in the C9orf72 and SOD1 genes in the incident population of ALS patients followed in the FILSLAN centres

lead_sponsor: University Hospital, Tours

sponsor_collaborators:
University Hospital, Tours
Biogen

location_facility: Paris - Groupe hospitalier de la Pitié Salpetrière


title: Analysis of the Immune Parameters Involved in the Onset and Fate of SARS-CoV-2 Infection in Patients With Multiple Myeloma (COVIMMUNOMM) COVID-19 and Multiple Myeloma

acronym: Covimmunomm

summary: Among all MM patients included in the cohort at the time of diagnosis of SARS-CoV-2 infection, blood samples will be collected at inclusion, at time of the infection acute phase in the most severe cases (when admitted in intensive care units), and at recovery. The following immune function tests will be evaluated, gammaglobulin measurements, lymphocytes counts, B, T, and NK cells analyses by cytometry, including exhaustion analyses. In addition, T cell repertoire sequencing looking for SARS-CoV-2- specific T cells, and serologies, will be evaluated at recovery and 6 months after MM treatment re-initiation.

status: Terminated

location_facility: CH Bretagne Atlantique Vannes et Auray-P.Chubert

location_facility: Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble