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 Hopitalier Universitaire de Brest

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Caen


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.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Acute Leukemia French Association

location_facility: Centre Hospitalier de Versailles André Mignot

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


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.

time_perspective: Prospective

lead_sponsor: Laboratoires Coloplast S.A.S

location_facility: Institut Mutualiste Montpelliérain- Beau soleil

location_facility: Centre Hospitalier Intercommunal Robert Ballanger

intervention_type: Device


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.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Diagnostic

lead_sponsor: Sunrise

location_facility: CHU Montpellier - Hôpital Gui-de-Chauliac

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

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


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.

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility: Hôpital d'Instruction des Armées Ste Anne

location_facility: Centre Hospitalier d'Elbeuf - Pneumologie

location_facility: Centre Hospitalier de Villefranche sur Saone

location_facility: Centre Hospitalier Intercommunal de Quimper

location_facility: Centre Hospitalier Universitaire DUPUYTREN

location_facility: Centre Hospitalier Intercommunal de Créteil


primary_purpose: Treatment

acronym: InTTercePT

intervention_type: Drug

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

lead_sponsor: UNICANCER

type: EudraCT Number

source: euctr

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.

location_facility: Groupe Hospitalier les Diaconesses Croix Saint Simon

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

location_facility: Centre Hospitalier Universitaire de Besancon

location_facility: Centre de Cancerologie du Grand Montpellier

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: CARIO - Centre Armoricain Radiothérapie Imagerie Médicale et Oncologi

location_facility: Centre Hospitalier Universitaire de Limoges

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

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.


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.

lead_sponsor: Nantes University Hospital

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

lead_sponsor_type: academique


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).

ReferenceType: background

ReferenceCitation: Courtier F, Carbuccia N, Garnier S, Guille A, Adélaïde 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.

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.

ipd_sharing: Undecided

lead_sponsor: French Innovative Leukemia Organisation

location_facility: Toulouse - IUCT Oncopole - Service d'Hématologie

location_facility: RENNES - Hôpital Pontchaillou - Hématologie

location_facility: NANTES - Hôpital Hôtel Dieu - Hématologie Clinique

location_facility: REIMS - Hôpital Robert Debré - Hématologie Clinique

location_facility: MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique

location_facility: POITIERS - Hôpital La Milétrie - Hématologie Clinique

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

location_facility: BAYONNE - CH de la Côte Basque - Hématologie


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.

primary_purpose: Prevention

lead_sponsor: University Hospital, Clermont-Ferrand

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

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

location_facility: BESANCON - Hôpital Jean Minjoz - Hématologie

location_facility: BEZIERS - Centre Hospitalier - Hématologie

location_facility: MULHOUSE - Hôpital E. Muller - Hématologie

location_facility: ANNECY - Centre Hospitalier Annecy-Genevois


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: Centre Hospitalier Regional Metz Thionville

location_facility: Hôpital Saint-Eloi - Hématologie Clinique

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: CHU Estaing - Hématologie Clinique Adulte

location_facility: CERGY-PONTOISE - Centre Hospitalier René Dubos

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

location_facility: ARGENTEUIL - Centre hospitalier Victor Dupouy

location_facility: Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

location_facility: Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

location_facility: CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique

location_facility: CHU Pontchaillou - Hématologie Clinique BMT-HC

location_facility: Centre Henri Becquerel - Service Hématologie Clinique

location_facility: Institut Paoli-Calmettes - 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.

primary_purpose: Other

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

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre de Lutte Contre le Cancer Jean-Perrin

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

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Assistance Publique-Hôpitaux de Marseille - La Timone

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Assistance Publique-Hôpitaux de Marseille - Hôpital Nord

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Strasbourg


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.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceType: derived

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.

lead_sponsor: University Hospital, Bordeaux

location_facility: Union Sportive Colomiers Rugby training center

location_facility: Aviron Bayonnais Rugby Pro Training Center

location_facility: Bordeaux University Hospital - Service UDH - Hôpital Pellegrin

location_facility: Training center Soyaux Angoulême XV Rugby

location_facility: Biarritz Olympique Pays Basque training center

location_facility: Training center Valence Romans Drôme Rugby

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

status_simplified: Completed


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.

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.

lead_sponsor: Intergroupe Francophone du Myelome

location_facility: Centre Hospitalier Intercommunal de Cornouaille

location_facility: Institut de Cancérologie Lucien Neuwirth

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

location_facility: CHU Poitiers - Pôle régional de Cancérologie

location_facility: CHV André Mignot - Université de Versailles

location_facility: CHRU Hôpital Haut Lévêque - Centre François Magendie

location_facility: Centre Hospitalier d'Argenteuil Victor Dupouy

location_facility: Centre Hospitalier Universitaire (CHU) de Limoges

intervention_type: Procedure


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.

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: Yes

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


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.

design_allocation: Non-Randomized

primary_purpose: Supportive Care

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


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

status: Active, not recruiting

lead_sponsor: University Hospital, Tours

location_facility: Paris - Groupe hospitalier de la Pitié Salpetrière

intervention_type: Genetic


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.

location_facility: Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble

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


status: Not yet recruiting

acronym: SCLERITA

title: Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis: a Phase II, Randomized, Controlled Trial

lead_sponsor: Assistance Publique - Hôpitaux de Paris

study_start_date_type: Anticipated

ReferenceCitation: Almeida C, Almeida I, Vasconcelos C. Quality of life in systemic sclerosis. Autoimmun Rev. 2015 Dec;14(12):1087-96. doi: 10.1016/j.autrev.2015.07.012. Epub 2015 Jul 23. Review.

ReferenceCitation: Mouthon L. SSc in 2011: From mechanisms to medicines. Nat Rev Rheumatol. 2012 Jan 10;8(2):72-4. doi: 10.1038/nrrheum.2011.203.

ReferenceCitation: Distler JH, Feghali-Bostwick C, Soare A, Asano Y, Distler O, Abraham DJ. Review: Frontiers of Antifibrotic Therapy in Systemic Sclerosis. Arthritis Rheumatol. 2017 Feb;69(2):257-267. doi: 10.1002/art.39865. Review.

ReferenceCitation: Wang Y, Fan PS, Kahaleh B. Association between enhanced type I collagen expression and epigenetic repression of the FLI1 gene in scleroderma fibroblasts. Arthritis Rheum. 2006 Jul;54(7):2271-9.

ReferenceCitation: Landi C, Bargagli E, Bianchi L, Gagliardi A, Carleo A, Bennett D, Perari MG, Armini A, Prasse A, Rottoli P, Bini L. Towards a functional proteomics approach to the comprehension of idiopathic pulmonary fibrosis, sarcoidosis, systemic sclerosis and pulmonary Langerhans cell histiocytosis. J Proteomics. 2013 May 27;83:60-75. doi: 10.1016/j.jprot.2013.03.006. Epub 2013 Mar 23.

ReferenceCitation: Kubo M, Ihn H, Yamane K, Tamaki K. Up-regulated expression of transforming growth factor beta receptors in dermal fibroblasts in skin sections from patients with localized scleroderma. Arthritis Rheum. 2001 Mar;44(3):731-4.

ReferenceCitation: Zhang Y, Liang R, Chen CW, Mallano T, Dees C, Distler A, Reich A, Bergmann C, Ramming A, Gelse K, Mielenz D, Distler O, Schett G, Distler JHW. JAK1-dependent transphosphorylation of JAK2 limits the antifibrotic effects of selective JAK2 inhibitors on long-term treatment. Ann Rheum Dis. 2017 Aug;76(8):1467-1475. doi: 10.1136/annrheumdis-2016-210911. Epub 2017 May 6.

ReferenceCitation: Migita K, Izumi Y, Torigoshi T, Satomura K, Izumi M, Nishino Y, Jiuchi Y, Nakamura M, Kozuru H, Nonaka F, Eguchi K, Kawakami A, Motokawa S. Inhibition of Janus kinase/signal transducer and activator of transcription (JAK/STAT) signalling pathway in rheumatoid synovial fibroblasts using small molecule compounds. Clin Exp Immunol. 2013 Dec;174(3):356-63. doi: 10.1111/cei.12190.

ReferenceCitation: Xu Y, Wang W, Tian Y, Liu J, Yang R. Polymorphisms in STAT4 and IRF5 increase the risk of systemic sclerosis: a meta-analysis. Int J Dermatol. 2016 Apr;55(4):408-16. doi: 10.1111/ijd.12839. Epub 2015 Dec 29. Review.

ReferenceCitation: Avouac J, Fürnrohr BG, Tomcik M, Palumbo K, Zerr P, Horn A, Dees C, Akhmetshina A, Beyer C, Distler O, Schett G, Allanore Y, Distler JH. Inactivation of the transcription factor STAT-4 prevents inflammation-driven fibrosis in animal models of systemic sclerosis. Arthritis Rheum. 2011 Mar;63(3):800-9. doi: 10.1002/art.30171.

ReferenceCitation: Kremer JM, Bloom BJ, Breedveld FC, Coombs JH, Fletcher MP, Gruben D, Krishnaswami S, Burgos-Vargas R, Wilkinson B, Zerbini CA, Zwillich SH. The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: Results of a double-blind, placebo-controlled phase IIa trial of three dosage levels of CP-690,550 versus placebo. Arthritis Rheum. 2009 Jul;60(7):1895-905. doi: 10.1002/art.24567. Erratum in: Arthritis Rheum. 2012 May;64(5):1487.

ReferenceCitation: Fridman JS, Scherle PA, Collins R, Burn T, Neilan CL, Hertel D, Contel N, Haley P, Thomas B, Shi J, Collier P, Rodgers JD, Shepard S, Metcalf B, Hollis G, Newton RC, Yeleswaram S, Friedman SM, Vaddi K. Preclinical evaluation of local JAK1 and JAK2 inhibition in cutaneous inflammation. J Invest Dermatol. 2011 Sep;131(9):1838-44. doi: 10.1038/jid.2011.140. Epub 2011 Jun 16.

ReferenceCitation: Deverapalli SC, Rosmarin D. The use of JAK inhibitors in the treatment of progressive systemic sclerosis. J Eur Acad Dermatol Venereol. 2018 Aug;32(8):e328. doi: 10.1111/jdv.14876. Epub 2018 Mar 6.

ReferenceCitation: Gordon JK, Martyanov V, Franks JM, Bernstein EJ, Szymonifka J, Magro C, Wildman HF, Wood TA, Whitfield ML, Spiera RF. Belimumab for the Treatment of Early Diffuse Systemic Sclerosis: Results of a Randomized, Double-Blind, Placebo-Controlled, Pilot Trial. Arthritis Rheumatol. 2018 Feb;70(2):308-316. doi: 10.1002/art.40358. Epub 2017 Dec 29.

location_facility:
CH Valenciennes
CHU Angers
CHU Bordeaux
CHU Lille
Hôpital Nord
Hospital Croix St Simon
Rangueil Hospital
CHU Montpellier - rhumatology
Avicenne Hospital
Hôpital Sud
La Timone Hospital
CHU Nancy
CHU Annecy
Saint Antoine Hospital
Robert Debré Hospital
CHU Tours
CHU Montpellier - St Eloi Hospital
Hospital Pasteur - CHU Nice
Cochin Hospital
CHU Poitiers
CHU Rouen
CHU Grenoble
CHU Lyon sud
Ambroise Paré hospital
CHU Gabriel Montpied
CHU Nantes
Henry Mondor hospital
CHU Caen
Nouvel Hospital Civil
CHU Limoges
CH Amiens
CHU Dijon

summary: The purpose of this study is to determine whether itacitinib is safe and effective in the treatment of systemic sclerosis in adults.


title: Observational Study of Patients Treated With Hot AXIOS® Prosthesis in Real Life Conditions -

acronym: REALAXIOS

summary:
Regulatory Context The CNEDiMTS makes the renewal of registration conditional on the transmission of the results of a well-conducted prospective study, carried out with Hot AXIOS, the objective of which is to evaluate the interest of this device in real conditions of use with regard to effectiveness and complications after a minimum follow-up of 3 months.

Operators are trained in the use of the equipment (practice on ex-vivo model and/or prior stent placement) and undertake to comply with the rules and formalities of use.

Primary efficacy objective :

To evaluate the efficacy of endoscopic trans digestive drainage after use of the Hot AXIOS prosthesis in the treatment of pancreatic collections (incompletely fluid or necrotic) at 3 months.

Secondary Objectives :

Assessment of the following elements :

Morbidity (complication rates) and mortality per- and post-procedure
Recurrence rate of pancreatic collection
Evolution of the quality of life questionnaire (SQ5D5L)
Technical success rate of prosthesis placement and removal success rate of the prosthesis
Search for factors predictive of clinical success of endoscopic pancreatic drainage with the Hot Axios prosthesis.

Study design Non-interventional/observational (RIPH 3 type), multi-center, prospective study with consecutive inclusions evaluating the Hot AXIOS® prosthetic device.

Non-inclusion registry A minimum amount of information will be collected anonymously, including sex, age, indication of drainage and reason for non-inclusion (e.g. refusal of the patient, of the investigator for impossibility of following the patient in the centre or other reasons to be specified). Generic information will be affixed in each centre participating in the study indicating: "In application of the provisions of the Data Protection Act, general information on the possibility that personal data may be used for research purposes must be provided in any establishment or centre where prevention, diagnosis and care activities are carried out". This must be exhaustive and rigorously maintained.

Equipment used in endoscopy Hot AXIOS™ - self-expanding metal prosthesis with a lumen diameter of 6 to 20 mm and collar length of 8 and 10 mm or any future similar device marketed under the same name at the time of the study.

Technique Insertion of the material under echo-endoscopic control -- possible but not systematic dilatation -- guide wire with hydrophilic tip - Puncture and release under echo-endoscopic control according to the centre's usual practice.

Registration The data will be collected anonymously in an electronic computer database using eCRFs.

Statistical analysis The evaluation of the clinical success of endoscopic pancreatic necrosectomy with metallic prosthesis will first consist in describing its efficacy according to the criteria described above.

Analysis plan :

The statistical analysis will first include a description of the study population with the number of patients falling under the indication and treated with the Hot AXIOS system at the recruiting centers (source population), the number of eligible patients who consented to participate in the study, the number of patients included (study population), the number of subjects who made each visit and were analyzed, premature exits (deaths, lost to follow-up) will be reported and described in the form of a flow chart.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Polyclinique Saint Côme
Poitiers Hospital
Nice Hospital
Limoges hospital
Lille Hospital
APHP saint antoine
Saint Etienne Hospital
Centre Hospitalier Jacques Lacarin
APHM
Avignon Hospital
European Hospital
Nancy Hospital
brest Hospital
Hôpital privé des peupliers
Clermont-ferrand hospital
Clinique Jean Mermoz
St Joseph Hospital


title: A Prospective Non-interventional Study Documenting the Management and Outcomes of Adult Patients With Acute Myeloid Leukemia (AML)

acronym: ALFAPPP

summary: During the last fifteen years, the landscape of AML diagnosis and therapeutical options has markedly evolved. Refined genetic and prognostic characterizations, together with new drug approvals and new allogeneic hematopoietic stem cell transplantation (HSCT) procedures, have increased patient journey diversity.

location_facility: Centre Hopsitalier de l'Est Francilien - Site de Meaux

location_facility: Centre Hospitalier de Versailles André Mignot


title: Assessing the Safety and Benefit of Home-hospitalization Program in the Management of Natalizumab (Tysabri®) Medication in Multiple Sclerosis

acronym: Tys at Home

summary:
At-home use of Natalizumab in multiple sclerosis (MS) patients has been temporarily granted by French security agency of medicines and Health products (ANSM). The main objective of the study is to compare the safety of natalizumab administration at home vs at hospital based on retrospective and prospective data collection. Quality of life, patient perception of at-home natalizumab administration are also evaluated as secondary objectives as well as medico-economic assessment of the method.

Data will be collected for a 12-month retrospective period and a 12-month prospective period.

location_facility: Adolphe de Rothschild Ophthalmological Foundation


acronym: ATLAS

summary:
MaaT013 is still in clinical development phase and is not approved yet for marketing in any region. During the development program, MaaT Pharma has undertaken initial development with closely related product candidates, leading to the Phase II HERACLES study in which MaaT013 preliminary safety and efficacy were assessed in the context of steroid-resistant, gastrointestinal aGraft versus Host Disease (SR-GI-aGvHD). In addition, a pivotal Phase III study (ARES trial) is planned.

In the absence of medical options in patients with gastrointestinal acute GvHD refractory to multiple lines of treatment, this early access program has been implemented.

status: Available

study_type: Expanded Access

lead_sponsor: MaaT Pharma

location_facility:
Chu La Miletrie
Chu Montpellier - Hopital Saint Eloi
Chu Grenoble
Crlcc Henri Becquerel
Institut Paoli Calmettes
Iuct - Oncopole
Chu Lyon Sud
Chu Morvan
Hopital Haut Leveque
Aphp - Hopital Sant Antoine
Chu de Caen
Chu Amiens Picardie Site Sud
Chu de Nice - L'Archet 1
Chu Rouen
Chu Angers
Chu de Rennes - Hopital Pontchaillou
Institut Gustave Roussy
Institut de Cancerologie de Strabsourg
MaaT Pharma
Chu de Lille

status_simplified: Unknown


title: Observational Study of the Use of DBLG1 System in Real Life

summary:
This study will be conducted on human subjects and is observational, prospective and uncontrolled, defined as a category 3 according to the Jardé Law (RIPH3). It is a national and multicentric study. Enrolled patients are Type 1 Diabetes (T1D) patients who receive the DBLG1 System (CE marked medical device) to be treated. Patients have their regular visits with their own clinician. No change from their usual care must and will be done, including trainings and treatment. At the end of the study, patients will keep their system for their usual care and will continue having usual follow-up visits with their clinician.

Data related to their glycemia, complications and quality of life will be collected for 1 year from the beginning of their treatment. A comparison with data collected during the 2 weeks of run-in period, prior to the activation of loop mode, is planned. In case the run-in phase lasts longer than 2 weeks, data collected from the two last weeks only will be kept for analysis and comparison.

The study is completed when all patients have their "end of study" file completed in the electronic Case Report Form (eCRF).

lead_sponsor: Diabeloop

location_facility: Groupe Hospitalier La Rochelle - Ré - Aunis


title: Multicentric Phase II-III Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma After a Favorable Response to Induction Chemotherapy

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

ReferenceCitation: Sauer R, Liersch T, Merkel S, Fietkau R, Hohenberger W, Hess C, Becker H, Raab HR, Villanueva MT, Witzigmann H, Wittekind C, Beissbarth T, Rödel C. Preoperative versus postoperative chemoradiotherapy for locally advanced rectal cancer: results of the German CAO/ARO/AIO-94 randomized phase III trial after a median follow-up of 11 years. J Clin Oncol. 2012 Jun 1;30(16):1926-33. doi: 10.1200/JCO.2011.40.1836. Epub 2012 Apr 23.

ReferenceCitation: Rödel C, Graeven U, Fietkau R, Hohenberger W, Hothorn T, Arnold D, Hofheinz RD, Ghadimi M, Wolff HA, Lang-Welzenbach M, Raab HR, Wittekind C, Ströbel P, Staib L, Wilhelm M, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R, Liersch T; German Rectal Cancer Study Group. Oxaliplatin added to fluorouracil-based preoperative chemoradiotherapy and postoperative chemotherapy of locally advanced rectal cancer (the German CAO/ARO/AIO-04 study): final results of the multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2015 Aug;16(8):979-89. doi: 10.1016/S1470-2045(15)00159-X. Epub 2015 Jul 15.

ReferenceCitation: Martin ST, Heneghan HM, Winter DC. Systematic review and meta-analysis of outcomes following pathological complete response to neoadjuvant chemoradiotherapy for rectal cancer. Br J Surg. 2012 Jul;99(7):918-28. doi: 10.1002/bjs.8702. Epub 2012 Feb 23. Review.

ReferenceCitation: Bregendahl S, Emmertsen KJ, Lous J, Laurberg S. Bowel dysfunction after low anterior resection with and without neoadjuvant therapy for rectal cancer: a population-based cross-sectional study. Colorectal Dis. 2013 Sep;15(9):1130-9. doi: 10.1111/codi.12244.

ReferenceCitation: Chen TY, Wiltink LM, Nout RA, Meershoek-Klein Kranenbarg E, Laurberg S, Marijnen CA, van de Velde CJ. Bowel function 14 years after preoperative short-course radiotherapy and total mesorectal excision for rectal cancer: report of a multicenter randomized trial. Clin Colorectal Cancer. 2015 Jun;14(2):106-14. doi: 10.1016/j.clcc.2014.12.007. Epub 2014 Dec 31.

ReferenceCitation: Schrag D, Weiser MR, Goodman KA, Gonen M, Hollywood E, Cercek A, Reidy-Lagunes DL, Gollub MJ, Shia J, Guillem JG, Temple LK, Paty PB, Saltz LB. Neoadjuvant chemotherapy without routine use of radiation therapy for patients with locally advanced rectal cancer: a pilot trial. J Clin Oncol. 2014 Feb 20;32(6):513-8. doi: 10.1200/JCO.2013.51.7904. Epub 2014 Jan 13.

ReferenceCitation: Weiser MR, Fichera A, Schrag D, Boughey JC, You YN. Progress in the PROSPECT trial: precision treatment for rectal cancer? Bull Am Coll Surg. 2015 Apr;100(4):51-2.

ReferenceCitation: Rouanet P, Rullier E, Lelong B, Maingon P, Tuech JJ, Pezet D, Castan F, Nougaret S; and the GRECCAR Study Group. Tailored Treatment Strategy for Locally Advanced Rectal Carcinoma Based on the Tumor Response to Induction Chemotherapy: Preliminary Results of the French Phase II Multicenter GRECCAR4 Trial. Dis Colon Rectum. 2017 Jul;60(7):653-663. doi: 10.1097/DCR.0000000000000849.

ReferenceCitation: Kang JH, Kim YC, Kim H, Kim YW, Hur H, Kim JS, Min BS, Kim H, Lim JS, Seong J, Keum KC, Kim NK. Tumor volume changes assessed by three-dimensional magnetic resonance volumetry in rectal cancer patients after preoperative chemoradiation: the impact of the volume reduction ratio on the prediction of pathologic complete response. Int J Radiat Oncol Biol Phys. 2010 Mar 15;76(4):1018-25. doi: 10.1016/j.ijrobp.2009.03.066. Epub 2009 Aug 3.

ReferenceCitation: Rouanet P. Which Trial to Demonstrate the Truthfulness of a Tailored Strategy in Rectal Carcinoma? Dis Colon Rectum. 2018 Jan;61(1):e1-e2. doi: 10.1097/DCR.0000000000000977.

ReferenceCitation: Nougaret S, Castan F, de Forges H, Vargas HA, Gallix B, Gourgou S, Rouanet P; GRECCAR Study Group. Early MRI predictors of disease-free survival in locally advanced rectal cancer from the GRECCAR 4 trial. Br J Surg. 2019 Oct;106(11):1530-1541. doi: 10.1002/bjs.11233. Epub 2019 Aug 22.

ReferenceCitation: Fokas E, Glynne-Jones R, Appelt A, Beets-Tan R, Beets G, Haustermans K, Marijnen C, Minsky BD, Ludmir E, Quirke P, Sebag-Montefiore D, Garcia-Aguilar J, Gambacorta MA, Valentini V, Buyse M, Rödel C. Outcome measures in multimodal rectal cancer trials. Lancet Oncol. 2020 May;21(5):e252-e264. doi: 10.1016/S1470-2045(20)30024-3. Review.

location_facility: Insitut Régional du Cancer de Montpellier

summary:
Locally advanced rectal carcinoma raise the issue of both the oncological control, local and general, and the therapeutic morbidity. Surgery alone can cure only one out of two patients, radiochemotherapy improves the local control but the metastatic risk remains about 30% with enhanced postoperative morbidity and poor functional results. The tumor response to preoperative treatment is the major prognostic factor which revealed the aggressiveness of the tumor. To this day, there are no biologic predictive markers for tumor response.

The purpose of this trial is to tailor the management according to the early tumoral response after short and intensive induction chemotherapy. MRI volumetric tumor response will be used to distinguish between good responders and bad responders.

"Very good" responders will be randomized to either immediate surgery or radiochemotherapy followed by surgery (Standard arm: Cap 50).


title: Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System

acronym: CHANGE

summary:
Multiparametric MRI of the prostate is recommended before each prostate biopsy. It identifies suspicious areas which will then be the subject of targeted biopsies. However, MRI suffers from low specificity and moderate inter-reader reproducibility, including with the use of the PI-RADS version 2.1 score.

We are developing, within the framework of RHU PERFUSE, a computer-aided diagnosis system (CAD) for the detection of ISUP ≥2 cancers. This system has been trained on a database of patients who had prostate MRI and prostatectomy at the Hospices Civils de Lyon and performed well on a database of patients who had prostate MRI before biopsy at the Hopices civils de Lyon.

However, one of the weaknesses of artificial intelligence systems is their low robustness when tested on MRI images from different manufacturers or institutions.

The goal of the CHANGE study is to build a prospective multicenter cohort of patients who underwent prostate multiparametric MRI followed by systematic and targeted prostate biopsies. The cohort will be used for the final external validation of the CAD developed in PERFUSE.

ReferenceCitation: Rouvière O, Souchon R, Lartizien C, Mansuy A, Magaud L, Colom M, Dubreuil-Chambardel M, Debeer S, Jaouen T, Duran A, Rippert P, Riche B, Monini C, Vlaeminck-Guillem V, Haesebaert J, Rabilloud M, Crouzet S. Detection of ISUP ≥2 prostate cancers using multiparametric MRI: prospective multicentre assessment of the non-inferiority of an artificial intelligence system as compared to the PI-RADS V.2.1 score (CHANGE study). BMJ Open. 2022 Feb 9;12(2):e051274. doi: 10.1136/bmjopen-2021-051274.

ipd_sharing_description: After publication of the results of the trial, the CHANGE cohort will be made partially accessible to other investigators wishing to test a CAD system aimed at detecting/localizing prostate cancer on MR images while respecting patient information. Request for access to pseudonymized data will be reviewed by the Trial Steering Committee that will grant access or not. To gain access, requestors will be required to sign a data access agreement. Of note, investigators will have access only to the MR images and not to the histological findings. After analysis of the CHANGE MR images by their CAD system, the investigator will be requested to send the results to the Hospices Civils de Lyon. The comparison between the CAD findings and the targeted and systematic biopsy findings will be made by the Hospices Civils de Lyon that will then inform the investigator of the CAD diagnostic performance.

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of urology and radiology, CHLS

location_facility: Department of Urology, Quint Fonsegrives

location_facility: Department of Urology, Clinique Beausoleil Montpellier

location_facility: Department of urology, CHU de Saint-Étienne Hôpital Nord

location_facility: Department of radiology and urology, Hôpital Edouard Herriot

location_facility: Department of Radiology and Urology, Institut Paoli-Calmettes Marseille

location_facility: Department of radiology and urology, CHU Pellegrin

location_facility: Department of urology and Radiology, CHU Grenoble Alpes

location_facility: Department of Radiology and Urology, Hopital Européen Marseille

location_facility: Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse

location_facility: Department of radiology and urology, Hôpital la Pitié Salpêtrière

location_facility: Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg

location_facility: Department Urology, Clinique urologique Nantes Atlantis

location_facility: Department of radiology and urology, Hôpital Saint Joseph Saint Luc

location_facility: Department of radiology and urology, CHU de Lille

intervention_type: Biological


title: Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma

acronym: RADIO-RYTHMIC

summary: The primary objective of the study : to compare the Recurrence-Free survival (RFS) between arms. RFS is defined as time from randomisation to the first recurrence (either local-regional or distant) or death of any cause.

location_facility: Institut de Cancérologie de l'Ouest Angers

location_facility: Institut de Cancérologie de Lorraine Nancy


title: Analysis of the Efficacy and Safety of Two Combination Treatment Regimens of Nivolumab and Ipilimumab in Patients With dMMR and / or MSI Metastatic Colorectal Cancer: A GERCOR Open-label, Randomized, Non-comparative, Two-stage Phase II Trial (NIPISAFE)

acronym: NIPISAFE

summary: NIPISAFE is open-label, phase II study, to identify a combination scheme of nivolumab and ipilimumab with a high level of clinical activity, but with a lower toxicity in MSI/dMMR Metastatic Colorectal Cancer (mCRC) patients.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Hopital Franco-Britannique - Fondation Cognacq-Jay

location_facility: Clinique Victor Hugo-Centre jean Bernard


title: Neoadjuvant Atezolizumab and Adjuvant Atezolizumab + Bevacizumab in Combination With Percutaneous Radiofrequency Ablation of Small HCC: a Multicenter Randomized Phase II Trial

summary:
Following the results of study IMbrave150, the combination Atezolizumab + Bevacizumab is a promising treatment option for patients with HCC.

In addition, the high intrahepatic distant recurrence rate and accumulating evidence for a metastatic mechanism encourages exploring adjuvant/neoadjuvant strategies targeting tumor growth and metastatic escape in the context of percutaneous thermal ablation for small HCC.

Local ablation of HCC is therefore an "ideal" setting for testing atezolizumab + bevacizumab in combination with ablation, with the aim of reducing the risk of recurrence.

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU de Montpellier
Centre Georges François Leclerc
CH Perpignan
CHU de Nice
CHU de Nantes
Hôpital Saint Joseph
CHU d'Angers
CHU de Grenoble
CHRU de Nancy
Hôpital Beaujon
Hôpital Jean Verdier
CHU Nîmes
Hôpital Cochin
CHU de Poitiers
Institut Gustave Roussy
CHU de Lille
CHU Amiens
CHU Dijon
CHU de Rennes


title: Creation of a Prospective Endodontics Database

acronym: REone

summary:
Endodontic treatment is necessary after certain dental trauma or in the presence of a large carious lesion, associated with signs of irreversible pulpal inflammation. The treatment of apical periodontitis is a real public health issue. The endodontic success rate is between 68 and 85%. Indeed, some studies show that systemic diseases such as diabetes can increase the prevalence and bone loss associated with apical periodontitis. Other studies identify apical periodontitis as a factor that can potentiate symptoms caused by inflammatory diseases such as cardiovascular disease and diabetes by increasing the level of inflammatory cells in the blood.

However, since 2014 the European Society of Endodontology has recommended establishing a higher level of evidence to ensure the link that these pathologies may have. For this, it is necessary to assess the criteria that may influence the healing of apical periodontitis.

Endodata has been developed by dental surgeons specializing in endodontics. The purpose of this software is to improve the clinical follow-up of patients and to establish a clinical and radiological database. In this context, the creation of a clinical database including data for all root canal treatment is of high interest.

location_facility: Assistance Publique des Hôpitaux de Paris, Hôpital Pitié Salpêtrière, Service d'Odontologie

location_facility: Assistance Publique des Hôpitaux de Paris, Hôpital Bretonneau, Service d'Odontologie

location_facility: Assistance Publique des Hôpitaux de Paris, Hôpital Henri Mondor, Service d'Odontologie

location_facility: UFR d'Odontologie, Laboratoire des Multimatériaux et Interfaces

location_facility: CHU de Bordeaux, Service de Médecine Buccodentaire

location_facility: Assistance Publique des Hôpitaux de Paris, Hôpital Charles Foix, Service d'Odontologie

location_facility: Hospices Civils de Lyon, Service d'Odontologie


acronym: TEDOVA

title: Randomized Phase II Study Comparing Neo-epitope Based Vaccine OSE2101 (TEDOPI®) With or Without Anti-PD1 (Pembrolizumab) Versus Best Supportive Care as Maintenance Treatment in Platinum-sensitive Recurrent Ovarian Cancer Patient With Controlled Disease After Platinum-based Chemotherapy

lead_sponsor: ARCAGY/ GINECO GROUP

type: Other Identifier

location_facility: CHU de Saint-Etienne - Pôle de Cancérologie

location_facility: Institut de Cancérologie de Strasbourg Europe - ICANS

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

location_facility: Groupe Hospitalier Diaconesses-Croix Saint-Simon

location_facility: Centre d'Oncologie et de Radiothérapie 37

summary:
The proposed study is an international randomized phase II, multicenter, open-label, three arms trial to assess best supportive care (BSC) vs OSE2101 and vs OSE2101 + pembrolizumab as maintenance treatment for patients with platinum sensitive relapsed ovarian cancers, previously treated with chemotherapy (regardless of the number of prior lines of platinum-based chemotherapy), bevacizumab (if eligible) and a PARP inhibitor (if eligible).

Patients in Complete Response, Partial Response, or Stable Disease at the end of chemotherapy with at least 4 cycles of platinum based chemotherapy will be randomized in one of the three arms (randomization 1:1:2). They will receive one or the two study treatments or BSC until progression, or intolerance, or up to 2 years (from 1st study treatment dose).


title: A Randomized Trial of Delayed Radiotherapy in Patients 1p/19q Codeleted Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery

acronym: POLO

summary: Because of their prolonged survival, patients with 1p/19q-codeleted low-grade oligodendrogliomas treated with RT + PCV are at risk of neurocognitive deterioration. We make the hypothesis that withholding radiotherapy until tumor progression could reduce the risk of neurocognitive deterioration without impairing overall survival.

location_facility: Institut de Cancérologie et Hematologie (ICH) - CHRU Brest, Hopital Morvan

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: Hôpital Pasteur - Hôpitaux civils de Colmar

location_facility: Institut Universitaire du Cancer Toulouse Oncopole


title: Optimization of the Parameters of Vagal Nerve Stimulation in Pharmaco- Resistant Epileptic Patients Based on a Surface EEG Index of Functional Connectivity (PLI: Phase Lag Index): a Randomized Double-blind Multicenter Controlled Study.

acronym: OPSTIMVAG

summary: Vagal nerve stimulation (VNS) is one of the neuromodulation techniques that can be indicated in patients suffering from refractory epilepsies, especially when an open resection has failed or is not indicated. However to date it is not possible to predict which patients will respond and what are the best parameters of stimulation to be set (pulse width, frequency and intensity). It has been shown that responders to VNS have reduced interictal cortical synchronicity on scalp EEG based on phase lag index (PLI), a marker of functional connectivity (Fc) The aim of this study is to test the following hypothesis: setting the parameters of stimulation on the basis of the lowest values of Phase Lag Index (PLI) obtained on scalp EEG with different settings of parameters (as compared with a randomly chosen set of commonly used parameters) will increase the rate of responders to VNS.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Department of functional explorations of the nervous system, CHU

location_facility: Department of clinical neurophysiology, Hôpital La Timone, APHM

location_facility: Epilepsy neurophysiopathology department, CHU Grenoble

location_facility: Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan

location_facility: Neurology and clinical neurophysiology, CHU Bretonneau


title: Ocular Conservative Treatment for Retinoblastoma: Efficacy of the New Management Strategies and Visual Outcome - RETINO 2018

summary:
This protocol includes 2 independent studies. Both studies are multicenter studies, evaluating different therapeutic approaches in two different populations of patients:

Study 1, a randomized phase-II study evaluating the efficacy of Intra-Arterial Chemotherapy (IAC) with melphalan and topotecan versus melphalan alone, both in association with ophthalmologic treatments.
Study 2, a minimally invasive interventional study evaluating the results on visual function following reference treatment with intravenous (IV) chemotherapy in association with ophthalmologic treatments.

location_facility: CHU ESTAING Centre Régional de Cancérologie et Therapie Cellulaire Pediatrique (CRCTCP)

location_facility: PARIS Fondation Ophtalmologique Adolphe de Rothschild

location_facility: MONTPELLIER CHU Hopital Arnaud De Villeneuve


title: Observational Register of Patients With haEmophilia A tReated With Afstyla®

acronym: OPERA

summary: Record real life data of patients with Hemophilia A and treated with Afstyla® to assess the effectiveness and the safety of the treatment used as prophylaxis, prevention of bleeding (e.g. surgery) or on-demand treatment during 3 years after patient inclusion

lead_sponsor: CSL Behring

location_facility:
CHU Nantes
Hôpital Simone Veil
CHU Clermont-Ferrand
CHU Saint-Etienne
CHU Caen
CHU Montpellier
CHU Brest
CHU Rennes
CHU Rouen
CHU Chambéry
CHU Limoges
Hôpital Mignot
Hôpital Necker
CHRU de Tours
CHRU Lille
CRC-MHC Hôpital Kremlin Bicêtre
Hôpital Hautepierre


title: Hizentra® in Inflammatory Neuropathies - pHeNIx Study

acronym: pHeNIx

summary: The pHeNIx study, a national multicentre prospective non-interventional study, should help to describe the conditions of use for Hizentra® and the methods for switching from the IV to SC route in everyday practice, together with the tolerability and efficacy of treatment, which is monitored using a patient application (PRO: Patient-Reported Outcomes).

location_facility:
CHU Nantes
Hôpital Pellegrin
Hôpital Roger Salengro, CHU Lille
Hôpital Pasteur
Hôpital Bicêtre
Hôpital de la Timone
CHRU Nancy
CHU Saint-Etienne
CHU Montpellier
CHU Angers
Hôpital Pierre Wertheimer,HCL
Hôpital Lariboisière
La Pitié-Salpêtrière
Hôpital Charles Nicolle
CHU Toulouse
CHRU Brest
CH Bayonne
Hôpital Henri Mondor
Hôpital privé de La Casamance
Hôpital Dupuytren


title: Rifabutin Versus Rifampicin for Treatment of Staphylococcal Prosthetic Joint Infection Treated With Debridement, Antibiotics and Implant Retention (DAIR Strategy): a Multicenter Randomized, Open-label, Non-inferiority Trial

acronym: RIFAMAB

summary: Rifampicin, is key in the treatment of staphylococcal PJIs. Rifabutin has a better profile of tolerance than rifampicin regarding the risk of interaction with concomitant medications and liver disorders. The hypothesis is that rifabutin may be an alternative antibiotic option as efficient as rifampicin for the treatment of staphylococcal PJIs, with a better safety profile. The investigator aim to demonstrate the non-inferiority of rifabutin as compared with rifampicin prescribed in combination treatment for PJIs.

lead_sponsor: Tourcoing Hospital

location_facility: Hôpital d'instruction des armées Sainte Anne


title: A Prospective, Multicenter, Open-label, Phase II Study to Evaluate Efficacy and Safety of Selective Internal Radiation Therapy Plus Xelox, Bevacizumab and Atezolizumab (Immune Chekpoint Inhibitor) in Patients With Liver-dominant Metastatic Colorectal Cancer

acronym: SIRTCI

summary: The main objective of the SIRTCI study is to evaluate the safety and efficacy of the combination chemotherapy (XELOX: Capecitabine plus oxaliplatin), anti-angiogenic (Bevacizumab), SIRT (TheraSphere®) and ICI (Atezolizumab) in patients with CRC with predominant liver metastases. SIRTCI is a single-arm, prospective, multi-centre phase II study. The main inclusion criteria are patients with MSS mRCC with predominantly non-operable liver metastases and measurable disease. Patients with extra-hepatic metastases can be included since the objective of the study is to induce local and abscopal effects of radiotherapy combined with ICI by stimulating the anti-tumour immune response to destroy both hepatic and extra-hepatic metastases.

ReferenceCitation: Wasan HS, Gibbs P, Sharma NK, Taieb J, Heinemann V, Ricke J, Peeters M, Findlay M, Weaver A, Mills J, Wilson C, Adams R, Francis A, Moschandreas J, Virdee PS, Dutton P, Love S, Gebski V, Gray A; FOXFIRE trial investigators; SIRFLOX trial investigators; FOXFIRE-Global trial investigators, van Hazel G, Sharma RA. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials. Lancet Oncol. 2017 Sep;18(9):1159-1171. doi: 10.1016/S1470-2045(17)30457-6. Epub 2017 Aug 3.

ReferenceCitation: Venook AP, Niedzwiecki D, Lenz HJ, Innocenti F, Fruth B, Meyerhardt JA, Schrag D, Greene C, O'Neil BH, Atkins JN, Berry S, Polite BN, O'Reilly EM, Goldberg RM, Hochster HS, Schilsky RL, Bertagnolli MM, El-Khoueiry AB, Watson P, Benson AB 3rd, Mulkerin DL, Mayer RJ, Blanke C. Effect of First-Line Chemotherapy Combined With Cetuximab or Bevacizumab on Overall Survival in Patients With KRAS Wild-Type Advanced or Metastatic Colorectal Cancer: A Randomized Clinical Trial. JAMA. 2017 Jun 20;317(23):2392-2401. doi: 10.1001/jama.2017.7105.

ReferenceCitation: Heinemann V, von Weikersthal LF, Decker T, Kiani A, Vehling-Kaiser U, Al-Batran SE, Heintges T, Lerchenmüller C, Kahl C, Seipelt G, Kullmann F, Stauch M, Scheithauer W, Hielscher J, Scholz M, Müller S, Link H, Niederle N, Rost A, Höffkes HG, Moehler M, Lindig RU, Modest DP, Rossius L, Kirchner T, Jung A, Stintzing S. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Sep;15(10):1065-75. doi: 10.1016/S1470-2045(14)70330-4. Epub 2014 Jul 31.

ReferenceCitation: Saltz LB, Clarke S, Díaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzén F, Cassidy J. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008 Apr 20;26(12):2013-9. doi: 10.1200/JCO.2007.14.9930. Erratum in: J Clin Oncol. 2008 Jun;26(18):3110. J Clin Oncol. 2009 Feb 1;27(4):653.

ReferenceCitation: Loupakis F, Cremolini C, Masi G, Lonardi S, Zagonel V, Salvatore L, Cortesi E, Tomasello G, Ronzoni M, Spadi R, Zaniboni A, Tonini G, Buonadonna A, Amoroso D, Chiara S, Carlomagno C, Boni C, Allegrini G, Boni L, Falcone A. Initial therapy with FOLFOXIRI and bevacizumab for metastatic colorectal cancer. N Engl J Med. 2014 Oct 23;371(17):1609-18. doi: 10.1056/NEJMoa1403108.

ReferenceCitation: van Hazel GA, Heinemann V, Sharma NK, Findlay MP, Ricke J, Peeters M, Perez D, Robinson BA, Strickland AH, Ferguson T, Rodríguez J, Kröning H, Wolf I, Ganju V, Walpole E, Boucher E, Tichler T, Shacham-Shmueli E, Powell A, Eliadis P, Isaacs R, Price D, Moeslein F, Taieb J, Bower G, Gebski V, Van Buskirk M, Cade DN, Thurston K, Gibbs P. SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer. J Clin Oncol. 2016 May 20;34(15):1723-31. doi: 10.1200/JCO.2015.66.1181. Epub 2016 Feb 22. Erratum in: J Clin Oncol. 2016 Nov 20;34(33):4059.

ReferenceCitation: Gruenberger T, Bridgewater J, Chau I, García Alfonso P, Rivoire M, Mudan S, Lasserre S, Hermann F, Waterkamp D, Adam R. Bevacizumab plus mFOLFOX-6 or FOLFOXIRI in patients with initially unresectable liver metastases from colorectal cancer: the OLIVIA multinational randomised phase II trial. Ann Oncol. 2015 Apr;26(4):702-708. doi: 10.1093/annonc/mdu580. Epub 2014 Dec 23.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Privé - Cac - Centre Georges François Leclerc


title: Observational Registry of Patients With Von WilLEbrand Disease Treated With Voncento®

acronym: OPALE

summary: Description of the long-term evolution of patients with von Willebrand disease and treated with Voncento® and of the hemostatic efficacy in the prevention and the treatment of non-surgical bleeding episodes and prevention of surgical bleeding during 2 years after patient inclusion.

location_facility:
CHU Besançon
Hôpital Simone Veil
CHU Nantes
CHU Lyon
Hôpital Bicêtre
CHRU Nancy
CHU Strasbourg
CHU Caen
CHU Rennes
CHU Bordeaux
CHU Rouen
Hôpital Cochin
CHU Lariboisière
Hôpital Mignot
Hôpital Necker
CHU Morvan Brest
Hôpital Saint-Eloi


title: Validation Study of a New Cytokine-based Dynamic Stratification Based on FLt3 Ligand Plasma Concentration Kinetic Profile and IL-6 Concentration During Induction of Acute Myeloid Leukemia

acronym: FLAMVAL

summary:
The investigators have recently demonstrated the strong impact in terms of survivals of Fms-like tyrosine kinase 3 ligand (FL) levels evaluated during intensive induction in acute myeloid leukemia (AML) patients. Indeed, three FL kinetic profiles were delineated: i) sustained increase of FL concentrations between day (D) 1 and D22 (FLI group, n=26, good-risk), ii) increase from D1 to D15, then decrease at D22 (FLD group, n=22, intermediate-risk) and iii) stagnation of low levels (<1000 pg/mL, FLL group, n=14, high-risk). However, with longer follow-up, the investigators have observed that FLI and FLD shared similar outcomes while FLL sub-group kept a very bad prognostic.

Because serum samples from this previous study (called the FLAM/FLAL study) had been frozen-stored, the investigators were able to conduct an ancillary study assessing the potential impact of the kinetics of 6 other cytokines: TNFalpha, stem-cell factor, IL-1beta, IL-6, IL-10 and granulocyte-monocyte colony-stimulating factor (GM-CSF).. Only Il-6 level at D22 (< or >15.5 pg/mL) was associated with outcome allowing to distinguish between higher and lower survivals within the combined FLI/FLD sub-group.

A new prognostic risk-stratification can thus be proposed as follows: FLI/FLD with IL-6 <15.5 pg/mL (favorable), FLI/FLD with IL-6 >15.5 pg/mL (intermediate) and FLL (high-risk).

The aim of this new FLAMVAL study is to validate prospectively in a larger and independent cohort this prognostic risk-stratification i.e. that kinetic profile of FLT3L plasma level from D1 to D22 and Il6 plasma level at day 22 during induction of AML patients are predictive of overall and disease free survivals.

For that purpose, 201 newly diagnosed AML patients treated intensively in the 25 centres of the French Innovative Leukemia Organisation (FILO) will be included in the FLAMVAL study.

lead_sponsor: Nantes University Hospital

location_facility:
Nancy University Hospital
Paoli-Calmette Institute
Poitiers University Hospital
Brest University Hospital
Basque coast hospital center
Nîmes University Hospital
Bordeaux University Hospital
Angers University Hospital
Strasbourg University Hospital
Reims University Hospital
Saint-Jean Hospital Center
Besançon University Hospital
Toulouse University Cancer Institute
AP-HP Cochin Hospital
Saint-Etienne University Hospital
Mulhouse Hospital Center
Clermont-Ferrand University Hospital
Béziers Hospital Center
Grenoble University Hospital
Nantes University Hospital
Montpellier University Hospital
Tours University Hospital
Rennes University Hospital
Lyon University Hospital
Mercy Regional Hospital


title: Observational Study of the Quality of Life of Patients With New Stoma Formation and Users of a Stoma Appliance From the SenSura Mio Range With Bodyfit® Technology

acronym: QoLMio

summary:
An ostomy is defined by the connection of a viscera to the skin, outside its natural location, by diversion from the digestive or urinary tract. The bodily injury, i.e. the creation of a stoma, has familiar, social and professional consequences. Personalized care, with the help of an ostomy nurse, is essential to accompany the ostomy patient in the changes of his or her life habits. In addition, the progress made in the various appliances, pouching and irrigation systems, contribute to improving the quality of life of these people.

In this context of adapted support, COLOPLAST has developed a range of ostomy pouches, the SenSura Mio BodyFit® technology range, for digestive or urinary stomas. The diversity of the devices makes it possible to find the most suitable combination to adapt to the morphology thanks to an elastic adhesive for a secure fit to individual body shape, and the textile materials used make it possible to optimize wearing comfort.

The aim of this study is to evaluate the quality of life of patients with recent ostomies with one of COLOPLAST's SenSura Mio devices at three months after discharge from the hospital. The condition of the skin around the stoma and the level of satisfaction of the patients will also be evaluated. Finally, the results obtained aim to identify factors predictive of a better quality of life in order to improve management.

lead_sponsor: Laboratoires Coloplast S.A.S

location_facility: Centre Hospitalier Du Cotentin Site de Cherbourg

location_facility: Centre Hospitalier Intercommunal Eure Seine

location_facility: Centre Hospitalier Universitaire La Miletrie

location_facility: Centre Hospitalier Annecy Genevois Site Annecy


title: Evaluation of the Relationship Between Anti-PD-1 Exposure and Tumour VOLUME in Patients Treated for Classical HODgkin's Lymphoma.

acronym: REVOLUMHOD

summary:
Anti-PD-1antibodies (iPD-1) are indicated as monotherapy in the treatment of adult patients with classical LH. The recommended dosage in LH is based on solid tumour experience and no dose-concentration-effect studies have been conducted.

According to the literature, therapeutic efficacy appears to be highly variable, and could be related to differences in treatment exposure.

Since Total metabolic tumor volume (TMTV) is a prognostic factor in LH and the clearance of iPD-1, and thus exposure to iPD-1, is related to clinical efficacy, we hypothesize that TMTV influences the exposure to iPD-1 and thus its therapeutic efficacy.

The aim of this study is to evaluate the relationship between TMTV and anti-PD-1 exposure in refractory or relapsed LH.

lead_sponsor: Rennes University Hospital

location_facility:
GHBS Lorient
CH Chartres
CH Orléans
CHU Angers
CHU Bordeaux
CH Quimper
CHBA Vannes
CHU Rennes
CRLCC Henri Becquerel
CH St Malo
CHU Nice
CH St Brieuc
CHU Tours
CHU Poitiers
Hôpital privé Sévigné
CHU Nantes
CHU Caen
CHU Montpellier
CHU Brest
APHP Saint Antoine
AP-HP Henri Mondor
CHU Dijon


title: A Phase II Single-group Assignment, Multicenter Study of Efficacy and Safety of Lorlatinib Monotherapy After Failure of First-line Tyrosine Kinase Inhibitor in Patients With Advanced ROS1-positive Non-small Cell Lung Cancer (ALBATROS)

summary:
ROS1 rearrangements are present in 1-2% of NSCLC cases and define a distinct molecular subgroup. Like ALK (anaplastic lymphoma kinase) rearrangements in NSCLC, ROS1 fusions confer sensitivity to the inhibitor crizotinib. Crizotinib, which is a tyrosine kinase inhibitor (TKI), has been shown to be effective in tumors in several retrospective studies.

Recently the FDA approved entrectinib for the treatment of patients with ROS1-positive metastatic NSCLC. This indication is based on the results of pooled data from several trials. Together, these studies demonstrate the efficacy for entrectinib across a variety of solid tumor types including NSCLC with ROS1 fusion.

However, despite the efficacy of crizotinib or entrectinib in ROS1-positive NSCLC, patients will develop resistance to these tyrosine kinase inhibitors.

Lorlatinib is a new and potent ROS1 / ALK inhibitor optimized to penetrate the blood-brain barrier. A recent study has investigated the activity of lorlatinib against the crizotinib-resistant ROS1G2032R mutation. In this situation, lorlatinib effectively inhibited the catalytic activity of recombinant ROS1G2032R resulting in an antiproliferative response. Because of its potency as an ROS1 inhibitor and its ability to suppress the resistant ROS1 mutations, lorlatinib could be a treatment of choice in ROS1-positive NSCLC.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Centre Hospitalier de Villefranche-sur-Saône

location_facility: Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis: a Prospective Multicenter Randomized Trial

acronym: DIVERTI 2

summary:
This study is designed to be a multicentre, prospective, comparative, randomised trial, evaluating the efficacy of two surgical strategies for the treatment of generalised peritonitis due to perforated diverticulitis. Results will be analysed according to an intention to treat principle (after selection and patient consent). Immediately before surgery, the patient will be randomly assigned to sigmoidectomy with primary anastomosis or to sigmoidectomy with primary anastomosis and diverting stoma. Sigmoidectomy will be performed through a midline laparotomy or laparoscopically according to the standard technique. In the control arm, a protective stoma will be performed at the end of surgery. A stoma reversal operation will be performed at least 3 months after the first operation and after performing a cologram by water soluble contrast between 4 and 8 weeks to check for the absence of fistula or stenosis at the level of the anastomosis. Stoma reversal will be performed with a trephine incision.

Post-stoma closure follow-ups will be planned and all morbidity/mortality will be recorded. All patients will be examined at 6, 12, and 24 weeks after the initial surgery, in the surgical department where they were operated; a final study visit will be carried out 12 months (evaluation of primary endpoint) after surgery. The parameters explored at medical examinations will be: • Occurrence of complications • Quality of life assessment

ReferenceCitation: Pinson J, Tuech JJ, Ouaissi M, Mathonnet M, Mauvais F, Houivet E, Lacroix E, Rondeaux J, Sabbagh C, Bridoux V. Role of protective stoma after primary anastomosis for generalized peritonitis due to perforated diverticulitis-DIVERTI 2 (a prospective multicenter randomized trial): rationale and design (nct04604730). BMC Surg. 2022 May 16;22(1):191. doi: 10.1186/s12893-022-01589-w.

lead_sponsor: University Hospital, Rouen

location_facility:
CHU Besançon
APHM Hôpital Nord
APHM La Timone
CHU Lyon
APHP Avicenne
CH Beauvais
CHU Nantes
APHP St Antoine
CHU Caen
CHU Clermont Ferrand
CHU Tours
CHU Brest
CHU Rouen
APHP Henri Mondor
CHU Nancy
CHU Grenoble
CHU Limoges
CHU Nimes
CHU Amiens


title: JAKINIB Study: " 'Observational', Multicentre Trial Collecting Prospective and On-going Clinical and Laboratory Data for Patients Treated With JAK Inhibitors for Inflammatory Rheumatism According to EMA."

acronym: MAJIK

summary:
Janus kinase (JAK) inhibitors are a new class of molecules available to the therapeutic arsenal for chronic inflammatory rheumatic diseases.The tolerance profile of this new class needs to be better defined and its use in real life further established.

The French Society of Rheumatologists intends to coordinate a prospective national registry study for this follow-up.

This registry will include at least 1500 Rheumatoid Arthritis (RA) and 150 patients with psoriatic arthritis from the start of treatment with JAK inhibitor and then followed for 5 years.

This registry is a longitudinal, multicentre, observational registry study. The objective of this national registry is to get a better understanding of the safety profiles of JAK inhibitors and get knowledge of their use in daily practice in order to optimize this use and potentially integrate JAK inhibitors into personalised medicine strategies.

This registry will generate efficacy data, especially therapeutic maintenance, observation, allowing inter-registry comparisons with other biologic compounds in the French population, and can be aggregated with other similar registries in other countries.

lead_sponsor: Societe Francaise de Rhumatologie

location_facility:
CHU Saint Etienne
CH Valenciennes
CH de Dijon
CH Chartres
CH Cholet
CHU Strasbourg
CH Pau
Polyclinique Vauban
CHU Lille
CHU Toulouse
CH Nevers
Hôpital Cochin
CH Colombes
CH Cannes
Private office
CH Antibes
CH Orleans
CH Bourg-en-Bresse
CH de Douai
AP-HP Saint Antoine
CH Saint Philibert
CHU Reims
AP-HP Avicenne
CHU Marseille Sainte-Marguerite
Hopital La Croix Saint Simon
CH Dax
CH Bégin
CH Morlaix
Infirmerie protestante de Lyon
CHU de Montpellier
CHU Nice
AP-HP Bichat
CHU de la Reunion
CHU Tours
AP-HP Pitie-Salpetriere
CH Saint Nazaire
CHU Clermont Ferrand
CHU Rouen
Hôpital Saint Joseph
CH Troyes
AP-HP Lariboisiere
CH Niort
CH Franche Comte
CHU de Bordeaux
CHD de Vendee
CHG Jacques Monod
CHU de Besançon
CH La Rochelle
CHU Nantes
CHU Lyon
CHU Caen
CH Le Mans
GH de Mulhouse
AP-HP Ambroise Pare
AP-HP Bicetre
CHRU Brest
AP-HP Henri Mondor
CH Mont de Marsan
CH Valence


title: Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Intensive Care Unit Patients

acronym: NICOVID-REA

summary:
There is currently no known treatment for COVID19. Active smokers are infrequent among patients with COVID-19 which has led our team to hypothesize that nicotine is responsible for this protective effect via the nicotinic acetylcholine receptor (nAChR). In fact, nAChR possess the ability to modulate ACE2 expression, the cellular doorway for SARS-CoV2. nAChR modulation by the virus would be responsible for the numerous clinical signs observed in COVID-19, including the cytokine storm manifested in intensive care hyperinflammatory patients.

Based on epidemiological data and experimental data from scientific literature, our team hypothesize that nicotine could inhibit the penetration and propagation of SARS-CoV2. Our team also claim that nicotine could attenuate the hyperinflammatory response and cytokine storm leading to acute respiratory failure and a probable multi-organ failure associated with COVID19.

ReferenceCitation: Labro G, Tubach F, Belin L, Dubost JL, Osman D, Muller G, Quenot JP, Da Silva D, Zarka J, Turpin M, Mayaux J, Lamer C, Doyen D, Chevrel G, Plantefeve G, Demeret S, Piton G, Manzon C, Ochin E, Gaillard R, Dautzenberg B, Baldacini M, Lebbah S, Miyara M, Pineton de Chambrun M, Amoura Z, Combes A; NICOVID-REA Trial Group. Nicotine patches in patients on mechanical ventilation for severe COVID-19: a randomized, double-blind, placebo-controlled, multicentre trial. Intensive Care Med. 2022 Jul;48(7):876-887. doi: 10.1007/s00134-022-06721-1. Epub 2022 Jun 9.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hospitalier Sud Francilien - Service de réanimation

location_facility: Centre Hospitalier Victor Dupouy - Service de Réanimation polyvalente et USC

location_facility: Grand Hôpital de l'Est Francilien - Site Jossigny - Réanimation

location_facility: Grand Hôpital de l'Est Francilien Site Meaux - Service de Réanimation Médico-Chirurgicale

location_facility: CHR Orléans Service de Médecine Intensive Réanimation

location_facility: Hôpital Bicêtre - Service de Médecine Intensive Réanimation

location_facility: Hôpital Tenon - Service de Médecine Intensive Réanimation

location_facility: Hôpital Simone VEIL - Service d'Anesthésie-Réanimation

location_facility: Groupement Hospitalier de la Région de Mulhouse Sud Alsace - Hop Emile MULLER

location_facility: Hôpital DELAFONTAINE Service de Médecine Intensive Réanimation

location_facility: Médipôle Hôpital Privé - MHP Service de Médecine Intensive Réanimation

location_facility: Hôpital Pitié Salpêtrière - Intensive care unit

location_facility: Centre Hospitalier René Dubos - Service de Réanimation Médico-Chirurgicale

location_facility: CHU Nice - Hôpital L'Archet 1 - Service de Médecine Intensive Réanimation

location_facility: CHU Dijon - Hôpital François Miterrand Service de Médecine Intensive Réanimation

location_facility: Institut Mutualiste Montsouris Service de Réanimation Polyvalente

location_facility: CHRU de Besançon - Service de Médecine Intensive Réanimation


title: Randomized, Open-label, Controlled Phase III Trial Comparing Pembrolizumab-platinum Based Chemotherapy Combination With Pembrolizumab Monotherapy in First Line Treatment of Non-small-cell Lung Cancers (NSCLC) With PDL1 Expression ≥50%

acronym: PERSEE

summary:
PERSEE is a French national phase 3 academic study comparing the chemotherapy-pembrolizumab combination to pembrolizumab alone as a first-line treatment for advanced NSCLC molecularly defined by a PDL1 expression ≥ 50% of tumour cells and no EGFR mutations or ALK rearrangement.

The main hypothesis is the superiority of the chemo-immunotherapy combination over mono-immunotherapy in terms of progression-free survival evaluated by an independent review committee.

One of the anticipated benefits of using the chemotherapy-pembrolizumab combination starting from the first line setting for NSCLC patients with PD L1 ≥ 50% is a reduced risk of early progression, which is known to occur with pembrolizumab monotherapy, and therefore, a better PFS.

ReferenceCitation: Descourt R, Chouaid C, Pérol M, Besse B, Greillier L, Bylicki O, Ricordel C, Guisier F, Gervais R, Schott R, Auliac JB, Robinet G, Decroisette C. First-line pembrolizumab with or without platinum doublet chemotherapy in non-small-cell lung cancer patients with PD-L1 expression ≥50. Future Oncol. 2021 Aug;17(23):3007-3016. doi: 10.2217/fon-2020-1202. Epub 2021 Jun 22.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility: Centre de lutte contre le cancer - Centre François Baclesse

location_facility: SAINT-PRIEST EN JAREZ - Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: Hôpital d'Instruction des Armées Toulon - Saint Anne


title: Psychological Impact of COVID-19 Outbreak on Caregivers Involved in Intensive Care Unit Patient Management: Impact on the Occurrence of Post-traumatic Stress Disorder, Anxiety, Depression and Burn Out Syndrome

acronym: PSY-CO-ICU

summary:
Based on the experience of previous pandemics, countries reacted by applying different upgrade strategies to prevent or delay the widespread of the disease. Therefore, measures such as border closure, school closure, restrict social gathering (even shutdown of workplaces), limit population movements, and confinement meaning quarantines at the scale of cities or regions. In public hospitals, several measures have been decided to concentrate the power of care on potential wave of admissions of patients with severe forms of Covid-19. In this purpose, the number of available beds in Intensive Care Units (ICU) has been increased by two-fold and scheduled non-emergency surgical procedure have been cancelled. That means:

For the most severe patients, new personals (physician such as anesthesiologists, nurses of other units) have been transferred in ICUs.
For the less severe patients, personals of non-busy units have been transferred in busier ones.

All these measures lead to major daily-life change sets that could be stressful. In the general population, it has been well documented that quarantine or confinement or isolation could lead to the occurrence of Post-Traumatic Stress Disorder (PTSD) syndrome in about 30% overall population. Importantly, high depressive symptoms have been reported in 9% of hospital staff. Numerous symptoms have been reported after quarantine or isolation such as emotional disturbance, depression, stress, low mood, irritability, insomnia, and post-traumatic stress symptoms.

In hospital setting, few studies have been performed for assessing the psychological impact of quarantine and isolation. However, two studies reported a high prevalence of burn-out syndrome (BOS) in ICU physician and PTSD syndrome and depression in ICU nurses. As the consequences of all the measures decided and applied during Covid-19 pandemic could be important on caregivers, the present study primarily aims at assessing the prevalence of PTSD syndrome in a large population of caregivers implied or not in Intensive Care Units. The secondary objective were 1) to assess the prevalence of severe depression and anxiety and BOS 2) to isolate potential factors associated with PTSD, severe depression, anxiety or BOS.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Intensive CAre Unit CHRU de Nancy, Hôpital Central

location_facility: Intensive care Unit, Hôpitaux civils de Lyon, Lyon Sud

location_facility: Hôpitaux civils de Lyon, Hôpital de la Croix Rousse

location_facility: CHU De Montpellier, Hôpital St Eloi-DAR B

location_facility: Intensive CAre Unit CHRU de Nancy, Hôpital de Brabois

location_facility: Intensive care Unit CHU de Brest Hôpital Cavale Blanche

location_facility: AP-HM, Hôpital Timone adultes, Neurotraumatology

location_facility: Intensive Care Unit, CHU de Nantes, Hôpital Laennec

location_facility: Intesive Care Unit CHRU de Strasbourg, Hôpital Hautepierre

location_facility: Intensive Care Unit, CHU de Nantes, Hôtel Dieu

location_facility: Hôpitaux civils de Lyon, Hôpital Edouard Herriot

location_facility: AP-HM, Hôpital Timone adultes, Intensive Care Unit

location_facility: CHU de Montpellier, Hôpital St Eloi SAR B

location_facility: CHU de Montpellier, Hôpital Guy de chauliac

location_facility: Hôpitaux civils de Lyon, Hôpital Louis Pradel

location_facility: Intesive Care Unit CHRU de Strasbourg, Hôpital civil


title: Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy: a Prospective Randomized Comparative Phase II Trial

summary:
This is a phase II, multicenter, randomized open-label and comparative study designed to evaluate whether local consolidative radiotherapy plus standard of care improves overall survival as compared to standard of care in patients with limited metastatic urothelial bladder cancer and without progression following the initial phase of first-line systemic therapy.

Each patient will be followed during 4 years from the date of randomization.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Institut de Cancerologie Lucien Neuwirth

location_facility: Groupement de Radiothérapie et d'Oncologie des Pyrénées


title: Extracorporeal Membrane Oxygenation (ECMO) as a Therapeutic Option in Severe Form of COVID-19: a Nationwide Cohort Study

acronym: ECMO-SARS

summary: The role of ECMO in the treatment of patients with severe COVID-19 (Acute Respiratory Distress Syndrome (ARDS) and/or acute refractory heart failure) is not yet known. The present study will aim to report the results of the ECMO management of the most severe forms of COVID-19 through the first French ECMO registry.

status: Unknown status

ReferenceCitation: Mansour A, Flecher E, Schmidt M, Rozec B, Gouin-Thibault I, Esvan M, Fougerou C, Levy B, Porto A, Ross JT, Para M, Manganiello S, Lebreton G, Vincentelli A, Nesseler N; ECMOSARS Investigators. Bleeding and thrombotic events in patients with severe COVID-19 supported with extracorporeal membrane oxygenation: a nationwide cohort study. Intensive Care Med. 2022 Aug;48(8):1039-1052. doi: 10.1007/s00134-022-06794-y. Epub 2022 Jul 13.

location_facility: APHM la Timone- Marseille University Hospital

location_facility: APHP La Pitié Salpêtrière Paris University Hospital

location_facility: APHP Henri Mondor Paris University Hospital

location_facility: Toulouse University Hospital - Rangueil Hospital

location_facility: APHP Kremli Bicetre Paris University Hospital

location_facility: APHP Hopital Européen Georges Pompidou - Paris University Hospital