title: Randomized Phase II Trial Evaluating [Radiotherapy-Docetaxel-5 Fluorouracil] Association Versus [Radiotherapy-Docetaxel-Cisplatin] Association in Non Resecables First Line of Chemotherapy in Metastatics Pancreas Cancers Patients

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

ReferenceCitation: Oberic L, Viret F, Baey C, Ychou M, Bennouna J, Adenis A, Peiffert D, Mornex F, Pignon JP, Celier P, Berille J, Ducreux M. Docetaxel- and 5-FU-concurrent radiotherapy in patients presenting unresectable locally advanced pancreatic cancer: a FNCLCC-ACCORD/0201 randomized phase II trial's pre-planned analysis and case report of a 5.5-year disease-free survival. Radiat Oncol. 2011 Sep 26;6:124. doi: 10.1186/1748-717X-6-124.

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


title: Radio-Surgical Treatment of Breast Cancer of Women Aged Over 70: Phase II Trial of Feasibility and Reproducibility of a Concentrated and Focalized Radiotherapy

summary:
RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for stage I or stage II breast cancer.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: UNICANCER

location_facility:
Centre Alexis Vautrin
Institut Bergonie
Centre Paul Strauss
Centre Hospitalier Lyon Sud
Centre Antoine Lacassagne
Hopital Saint-Louis
CHU Pitie-Salpetriere
Centre Oscar Lambret
Institut Gustave Roussy
Centre Leon Berard

intervention_type: Radiation

lead_sponsor_type: industriel

status_simplified: Completed


title: First Line Treatment of Metastatic Hormone Refractory Prostate Cancer With a Combination of Novantrone-Navelbine

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

status: Unknown status

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne/Mer

intervention_type: Drug

status_simplified: Unknown


title: Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients: A Randomized, Multicenter Trial

acronym: PEPITS

summary:
Schizophrenia affects about 0.7% of the population. Poor insight, which is common in this disease, linked to poor drug compliance is leads to rehospitalisation with major impact on quality of life. Indeed, many patients relapse with exacerbation of symptoms.

Psychoeducation can improve therapeutic alliance and medication compliance.

In this context, an individual psycho-education program (PEPITS) has been developed. PEPITS carried out by nurses during the initial stages of hospitalisation.

The hypothesis is that PEPITS program will decrease relapse and improve the compliance and insight and and so the quality of life.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

lead_sponsor: University Hospital, Tours

location_facility:
Service de psychiatrie
Serrvice de Psychiatrie

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Inflammation in Intrahepatic Cholestasis of Pregnancy

acronym: INTREPIDE

summary:
This observational prospective study will help to determine if an immune process similar to allograft rejection is responsible for the occurrence of an intrahepatic cholestasis of pregnancy (ICP).

If so, it would suggest the potential benefit of immunomodulatory therapeutics.

study_start_date_type: Anticipated

status: Not yet recruiting

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Du Q, Pan Y, Zhang Y, Zhang H, Zheng Y, Lu L, Wang J, Duan T, Chen J. Placental gene-expression profiles of intrahepatic cholestasis of pregnancy reveal involvement of multiple molecular pathways in blood vessel formation and inflammation. BMC Med Genomics. 2014 Jul 7;7:42. doi: 10.1186/1755-8794-7-42.

ReferenceCitation: Patel S, Pinheiro M, Felix JC, Opper N, Ouzounian JG, Lee RH. A case-control review of placentas from patients with intrahepatic cholestasis of pregnancy. Fetal Pediatr Pathol. 2014 Aug;33(4):210-5. doi: 10.3109/15513815.2014.899413. Epub 2014 Apr 23.

ReferenceCitation: Larson SP, Kovilam O, Agrawal DK. Immunological basis in the pathogenesis of intrahepatic cholestasis of pregnancy. Expert Rev Clin Immunol. 2016;12(1):39-48. doi: 10.1586/1744666X.2016.1101344. Epub 2015 Oct 15. Review.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CH Bretagne Sud
CHU de Caen
CHU de Tours
CHU de Brest
CH de Quimper
Polyclinique KERAUDREN
CH de Chambery
CHU de Rennes


type: Other Identifier

title: French Acute Randomized Controlled Trial Using Multimodal Imaging for Endovascular Treatment of Patients With Large Cerebral Infarction With Substantial Penumbra up to 24 Hours

acronym: FrameLP

summary: Large cerebral infarctions are frequent and associated with a poor outcome. Previous cohort studies results suggest that patients with an acute ischemic stroke with large core and substantial penumbra on perfusion imaging benefit from EVT while those with no salvageable ischemic tissue did not. The Investigator aim to demonstrate in a randomized controlled trials (RCT) that EVT (Endo Vascular Treatment) in addition to BMT (Best Medical Treatment) increases the rate of functional recovery (mRS 0-2) at 3 months in patients with a LVO-related AIS with a large core and substantial penumbra evolving for less than 24hrs

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

location_facility: University Hospital of Montpellier Hôpital Gui de Chauliac

location_facility: Fondation Adolphe de Rothschild Hospital

location_facility: University Hospital of Nancy (CHRU) Hôpital central

location_facility: University Hospital of Lille Hôpital Roger Salengro

location_facility: University Hospital Pitié-Salpétrière AP-HP

location_facility: University Hospital of Limoges Hôpital Dupuytren 1

intervention_type: Procedure


title: Randomized Controlled Trial of a Low-Protein Diet (LPD) With Low-Protein (LP) Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD): Efficacy and Feasibility Study

summary: The KDOQI 2020 - Clinical practice guideline for nutrition in chronic kidney disease (CKD) -recommends protein restriction to reduce the risk of end-stage renal disease/death and improve quality of life, a low protein diet providing 0.55-0.60g dietary protein/ kg body weight/day is recommended. FLAVIS® is a product line of hypoprotein foods specially developed for the treatment of CKD.The use of low-protein foods may facilitate the achievement of nutritional goals in terms of protein intake and help patients to follow a low-protein diet.

primary_purpose: Prevention

lead_sponsor: Dr. Schär AG / SPA

location_facility:
Hôpital Nord-Ouest
CH Le Mans
Cabinet médical du Dr Magnant
AURA Paris
Maison du Rein
CHU Gabriel Montpied
CH Mâcon
Hôpital la conception
Hospices Civiles de Lyon


title: Development of a Severity Assessment Score for Nasosinus Polyposis (PSI Score)

acronym: PSI

summary: nasosinus polyposis (=PNS) is a chronic inflammatory disease of the nasal cavity and sinus cavity with a prevalence of 2 to 4% in the general population. The functional impact of PNS has a major impact on one's quality of life.Medical treatment, nasal irrigations and local glucocorticoids as well as short treatment of oral glucocorticoids have shown a short-term benefit versus placebo. Surgery improves the efficacy of local treatments, but 40% of patients have a recurrence of polyps at 18 months and 20% of patients require a surgery recovery at 5 years. The development of monoclonal antibodies directly targeting the inflammatory way is a real public health issue. Bachert C. et al recently demonstrated the efficacy of Dupilumab (anti-IL-4/13 antibody) injected subcutaneously on the overall symptomatology of PNS. The marketing authorization (AMM) for the first biotherapy to be available soon includes PNS's severe nature and resistance to treatment, although there is no consensus definition or score to characterize this severity. This study aims at developping a score for assessing severity in PNS. We suggest that this assessment strategy could be applied to the PNS. The originality and the innovative character of this project is the statistical modeling behind the creation of the score. Thus, the importance of symptoms, anatomical and biological factors, the estimation of the quality of life of the patients, the level of care use and the number of surgeries all become measurable indicators that are a direct reflexion of the severity and the control of PNS, called latent variables because they cannot be directly measured. To consider this detail, modeling using structural equations seems optimal to develop a severity score (PSI score) of PNS in order to personalize the therapeutic care of patients. Main Objective: To develop a severity score for PNS using latent variable modeling: Polyps Severity Index (PSI)

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Hôpitaux Universitaires de Marseille Conception


title: Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia

acronym: RAVEN

summary: The purpose of this study is to collect medical informations and samples from refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax treatment, in order to evaluate the frequency of resistance mechanisms.

time_perspective: Retrospective

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Hopital Pitié Salpetrière
CHU clermont-ferrand
IUCT Oncopole
Hopital AVICENNE
Centre LEON BERARD
Hopital Haut LEVEQUE
CHU Nancy
CHU Grenoble
CHU de Reims


title: Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer - Randomized, Placebo-controlled, Double-blind Study

acronym: QISEIN

summary: This is a multicenter randomized trial in breast cancer patients reporting cancer-related fatigue to evaluate the efficacy and safety of Qiseng® based on extract of American ginseng combined with vitamin C from extract of Camu Camu berries

lead_sponsor: Centre Francois Baclesse

location_facility:
Polyclinique du Parc
ARCOCEA_Clinique Europe
Ch Cherbourg
Ch Calais
Centre Pierre Curie
Centre Henri Becquerel
Clinique de Flandre
Centre François Baclesse
Clinique des Dentellières

intervention_type: Dietary Supplement


title: Randomized, Double-blind, Multicenter Placebo-controlled Study Evaluating Neurotoxicity in Patients With Metastatic Gastro Intestinal Cancer Taking Phycocare® or Placebo During Oxaliplatin Based Chemotherapy

acronym: PROPERTY

summary:
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most frequent side effects caused by antineoplastic agents, with a prevalence from 19% to over 85%. Clinically, CIPN is a mostly sensory neuropathy that may be accompanied by motor and autonomic changes of varying intensity and duration.

Due to its high prevalence among cancer patients, CIPN constitutes a major problem for both cancer patients and survivors as well as for their health care providers, especially because, at the moment, there is no single effective method of preventing CIPN; moreover, the possibilities of treating this syndrome are very limited.

The phycocyanin (PC), a biliprotein pigment and an important constituent of the blue-green alga Spirulina platensis, has been reported to possess significant antioxidant and radical-scavenging properties, offering protection against oxidative stress.

Study hypothesis is that phycocyanin may give protection against oxaliplatin-induced neuropathy in the treatment of gastro intestinal cancers including oesogastric, colo-rectal and pancreatic cancers. This trial will be a randomised placebo-controlled study.

lead_sponsor: Nantes University Hospital

location_facility:
Nantes Uh
Saint Gregoire Clinique
Foch Suresnes Hosptial
Clermont-Ferrand UH
Mutaliste Clinic Saint Nazaire
Leon Berard Research Cancer Center
Chd La Roche Sur Yon
DIJON UH


title: SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases

acronym: SATORI

summary: Biopsies are performed in several autoimmune diseases to diagnose or classify them Tolerance and information of the patients have been poorly evlauated our objective is to evaluate tolerance and information of the patients after the biopsies for salivary gland, temporal arteries and neuromuscular.

location_facility:
CHU de LILLE
Hôpital de la Salpétrière
CHU d'ANGERS
CHU de Tours
CHRU de Brest
CHU de Marseille
CH de Quimper
CHU de Bordeaux


title: Management of the Lack of Blood Return on a Central Venous Catheter (CVC) Before Chemotherapy in a Day Unit: Phase III Randomised Multicentre Study

acronym: CATAREV-B

summary: Compare two methods of managing the lack of CVC blood return : opacification using contrast media injection or radio-clinical method with a simple chest X-ray followed by a rapid infusion of physiological serum

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Institut du Cancer Sainte Catherine Avignon Provence


title: Postoperative Pain Evaluation After Definitive Root Canal Obturation With Zinc Oxide/Eugenol-type Sealer Containing or Not 1% Prednisolone Acetate - Steroid Anti-inflammatory Agent: a Comparative, Randomized Clinical Trial.

summary:
The study design is a multicentric randomized controlled clinical trial. 238 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (119 in each group).

The aim is to assess the effectiveness and utility of the ancillary drug substance, prednisolone acetate (1%) contained in CORTISOMOL SP (Zinc Oxide/Eugenol-type sealer) to help to decrease the possible postoperative painful reactions after root canal treatment. SEALITE REGULAR, which has a similar formulation except it is prednisolone acetate-free, is used as the comparator sealer.

Procedures of root canal treatment will be conventional and standardized for all investigational centers. The canals will be cleaned, shaped and then obturated using a Zinc oxide/Eugenol-type sealer (CORTISOMOL SP or SEALITE REGULAR) and gutta-percha.

Patients assess their pain for 7 days after permanent root canal obturation.

lead_sponsor: ACTEON Group

location_facility:
Cabinet dentaire
CHU Rennes - Centre de Soins Dentaires

intervention_type: Device


title: Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced Non-small Cell Lung Cancer Patients (NSCLC)

acronym: CIRCULAR

summary: Multicenter prospective cohort study aiming to evaluate the detection rate of EGFR gene mutation in patients with advanced NSCLC in a real-word clinical setting, based on liquid biopsy and tissue analyses.

primary_purpose: Screening

lead_sponsor: Institut Bergonié

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

intervention_type: Diagnostic Test


title: Randomized Controlled Trial for Efficacy Assessment of a Program of Digital Accompaniment to Optimize Homework Performances and Increase Familial Quality of Life in 9 to 16 Years Children With ADHD" - PANDA-H

acronym: PANDA-H

summary:
Attention Deficit Disorder with or without Hyperactivity (ADHD) is a frequent pathology in children that has important consequences on schooling both in terms of academic level (due to the attentional disorder) and behavior (disruption of the class). ADHD also has an impact on family functioning, which can generate stress and family altercations. The homework period can be a particularly tense time and a source of conflict with the child, which has negative consequences on the family atmosphere, learning efficiency and of course academic success.

The investigators wish to evaluate an innovative digital device (a smartphone application) to accompany the child during homework periods.

primary_purpose: Other

location_facility:
Olivier Bonnot
Bioulac
Caci
Berquin
Purpuer
Delorme
Schroder
Fourneret
Speranza


type: EudraCT Number

title: Comparison Between Prednisolone and Dexamethasone on D28 Mortality in Patients on Oxygen Therapy, With CoViD-19: Multicenter, Randomized, Open-label Non-inferiority Study

acronym: COPreDex

summary: The aim of the study is to evaluate two differents regimens of corticosteroids (prednisolone versus dexamethasone) on D28 mortality in patients with CoViD 19 pneumonia requiring oxygen supplementation

lead_sponsor: Centre Hospitalier René Dubos

location_facility: Department of Emergency, Hospital Victor Dupouy

location_facility: Department of Infectious and Tropical Diseases, Hospital René Dubos,

location_facility: Department of Pneumology and Infectious Diseases, Hospital of Saint-Quentin

location_facility: Department of Infectious Medicine, Hospital of Gonesse

location_facility: Department of Infectious and respiratory Diseases, Hospital Delafontaine

location_facility: Department of Pneumology and Infectious Medicine, Hospital Carnelle Portes de l'Oise

location_facility: Department of Infectious and Tropical Diseases, Hospital Simone Veil

location_facility: Department of Internal Medicine, Hospital Emile Roux - Le Puy-en-Velay


title: Comprehensive Chromosomal Testing of Trophectoderm Biopsies of Blastocysts to Improve Live Birth Rates After in Vitro Fertilization: a Prospective Randomized Trial

acronym: Devit

summary:
Preimplantation embryo aneuploidy is a major source of adverse outcomes in human reproduction since it leads to implantation failure, early pregnancy loss or severe chromosomal diseases. The risk of embryos aneuploidy is drastically increased after 35 years old. The intra uterine transfer of euploid embryos assessed through such techniques as next-generation sequencing (NGS) based Comprehensive chromosomal Testing of Trophectoderm (TE) biopsies of Blastocysts (CTTEB), may improve implantation and live birth rates, and decrease miscarriage rates. But no randomized controlled trial (RCT) was ever performed to test the interest of CTTEB for women that really needed it (≥35 to ≤ 41 years old). In this multicentre randomized-controlled-trial, the investigators will compare live birth rate obtained after the first single frozen-thawed blastocyst transfer cycle following the freeze-all-Intracytoplasmic sperm injection cycle in infertile and old couples between two different strategies of Day 5/6 blastocyst selection:

Control group: morphological criteria (Istanbul consensus)
Interventional group: international recommendations after CTTEB (www.pgdis.org; Newsletter May 27, 2019).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
CHU Nantes
CHU Clermont-Ferrand
CHU Strasbourg
Hôpital Antoine Béclère
Hôpital Arnaud de Villeneuve
Hôpital Cochin
Hopital Tenon
CHU Dijon


title: AK Socket Evaluation : Sub-ischial vs Ischial Containment. Multi-center Randomised Crossover Study

summary: Socket is key to provide comfort and function to lower limb amputees. A new socket, the sub-ischial socket, will be compared to "traditional" ischial containment sockets, based on comfort self-evaluation, and locomotor capacities.

lead_sponsor: Proteor Group

location_facility:
Centre Mutualiste de Kerpape
Hôpital Léon Bérard
CHBA Vannes
UGECAM La Tourmaline
UGECAM - IRR Nancy
UGECAM La Tour de Gassies
Clinique du Cabirol
Institution Nationale des Invalides
Les Capucins


title: Assessment of Therapeutic Plasma Exchange to Improve Respiratory Function by Alleviating Cytokine Storm During Severe Covid-19 Infections Randomised Open-label Controlled Trial

acronym: CovidEP

summary:
Severe Covid-19 (Coronavirus Disease 2019) infections generate major but inappropriate production of cytokines and, in some cases, generate anti-IFN (Interferon) auto-antibodies, inducing acute respiratory distress syndrom (ARDS). Therapeutic plasma exchange (TPE) have been reported to be efficient for improving the hyperinflammatory condition state and the respiratory function, which has been described in case reports or small series.

The study aims to remove cytokines during cytokine storm and anti-IFN auto-antibodies (when present) to prevent developpement of an inappropriate immune response and to improve the clinical response to reanimation treatment, in particular the respiratory parameters leading to a rapid improvement of clinical status. To that aim, the study investigates to compare a treatment using TPE plus usual treatments in intensive care unit (experimental arm) versus usual treatments in intensive care unit (routine arm) in a randomised trial.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Pitié Salpétrière - Assistante Publique des Hôpitaux de Paris

location_facility: Groupement Hospitalier Porte de Valence - Montélimar


title: Relapse in Previously Irradiated Prostate Bed : a Phase I/II Study of Stereotactic Ablative Reirradiation Potentiated by Metformin

summary: This phase I/II escalation dose study is assessing the efficacy of the recommended dose of stereotactic re-irradiation (SBRT) of relapses within the prostatectomy bed, potentiated by metformin

design_allocation: Non-Randomized

location_facility:
Institut de Cancerologie de L'Ouest
Centre LEON BERARD
Centre GEORGES FRANCOIS LECLERC
Centre Eugene Marquis
CHRU de BREST - HOPITAL MORVAN
Chru Bretonneau
Centre OSCAR LAMBRET


title: ProAdrenomedullin Assessment of Multi-Organ Failure in COvid-19 Sepsis

acronym: PAMOCOS

summary: COVID-19 is a worldwide pandemic. Around 5% of infected patients are admitted in ICU, mainly for respiratory failure. Outcome of these patients is linked to other organ failures. Optimal therapies are not defined so far. The sponsor want to assess the role of MR-ProADM as prognostic biomarker, and the impact of treatments (including supportive treatments) on MOF occurrence and outcome.

lead_sponsor: Centre Hospitalier de Lens

location_facility:
Hospital of Boulogne/mer
Hospital of Arras
Hospitalier of Valenciennes
Hospital of Dunkerque
Hospital of Tourcoing
Hospital Dr Schaffner
Hospital of DOUAI
Hospital of Roubaix


title: Validation Study on Eye Rubbing Questionnaire in Patients With or Suspected of Having a Keratoconus (KC)

acronym: QFK

summary:
KC is a degenerative disorder of the cornea. Keratoconus etiopathogenesis remains unclear and may rely on environmental and genetic factors. Usually considered as a rare disease (<1/2000), but the prevalence is nowadays growing worldwide up to 1/500. In that pathology, cornea progressively gets thinner, and there is a deformation of the corneal surface which can induce high order optical aberrations and visual impairment.

Eye rubbing is certainly the main factor in the progression or development of keratoconus (KC), yet it is only very partially evaluated and quantified in current management. Environmental and clinical factors will be collected and associated with a eye rubbing Questionnaire, specifically pointing out eye rubbing.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre National Ophtalmologique des Quinze Vingt


title: Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO Prescribed by AMM in Prostate Cancer

acronym: XOFIGO

summary:
Since 13 November 2013, XOFIGO has been authorised on the European zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases.

bone metastases frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy.

Bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment.

Xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases.

ReferenceType: result

ReferenceCitation: Harrison MR, Wong TZ, Armstrong AJ, George DJ. Radium-223 chloride: a potential new treatment for castration-resistant prostate cancer patients with metastatic bone disease. Cancer Manag Res. 2013;5:1-14. doi: 10.2147/CMAR.S25537. Epub 2013 Jan 8.

ReferenceCitation: Nilsson S, Strang P, Aksnes AK, Franzèn L, Olivier P, Pecking A, Staffurth J, Vasanthan S, Andersson C, Bruland ØS. A randomized, dose-response, multicenter phase II study of radium-223 chloride for the palliation of painful bone metastases in patients with castration-resistant prostate cancer. Eur J Cancer. 2012 Mar;48(5):678-86. doi: 10.1016/j.ejca.2011.12.023. Epub 2012 Feb 15. Review.

ReferenceCitation: Parker CC, Pascoe S, Chodacki A, O'Sullivan JM, Germá JR, O'Bryan-Tear CG, Haider T, Hoskin P. A randomized, double-blind, dose-finding, multicenter, phase 2 study of radium chloride (Ra 223) in patients with bone metastases and castration-resistant prostate cancer. Eur Urol. 2013 Feb;63(2):189-97. doi: 10.1016/j.eururo.2012.09.008. Epub 2012 Sep 13.

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

location_facility:
IPC Marseille
Chu Grenoble
ICO Bordeaux
Icm Val D'Aurelle
APHP Hopital Cochin
ONCOLOPE
UP Clermont Ferrand
CRLC de Nantes


title: Phase II Study to Assess Preoperative Hypofractionated Stereotactic Radiotherapy of Brain Metastases

acronym: STEP

summary: STEP is a French multicentre, prospective, non-randomized, phase II study designed to assess 6-months local control after pre-operative stereotactic radiosurgery (SRS) for patients with brain metastases

ReferenceCitation: Ginzac A, Dupic G, Brun L, Molnar I, Casile M, Durando X, Verrelle P, Lemaire JJ, Khalil T, Biau J. Preoperative stereotactic radiosurgery for brain metastases: the STEP study protocol for a multicentre, prospective, phase-II trial. BMC Cancer. 2021 Jul 28;21(1):864. doi: 10.1186/s12885-021-08602-0.

lead_sponsor: Centre Jean Perrin

location_facility: Institut de cancérologie de la Loire Lucien Neuwirth

location_facility: Institut de cancérologie Strasbourg Europe (ICANS)


title: Characterization of a Functional Test for Mediterranean Family Fever Screening - 2

acronym: DEPIST-FMF 2

summary:
Familial Mediterranean fever (FMF) is the most common auto-inflammatory disease (prevalence: 1-5 / 10,000 inhabitants). It is caused by mutations in the MEFV gene, which encodes variants of the Pyrine inflammasome. Inflammasomes are protein complexes of the innate immunity that produce pro-inflammatory cytokines (interleukin-1β).

In vitro, our preliminary results demonstrated that the activation of the inflammatory pyrine (measured by the concentration of interleukin-1β) by kinase inhibitors is significantly increased in FMF patients compared to healthy subjects. Furthermore, a measurement of cell death gave significant results in differentiating the patients from the controls.

The performance of this functional has been tested, fast and simple diagnostic test on common mutations and wish to assess its characteristics for MEFV mutations.

The investigators hypothesize that this quick and simple functional test can serve as a diagnostic tool for FMF and can quantitatively discriminate against patients with different mutations (genotypes).

location_facility: Service de Pédiatrie - CHU de Nîmes - Hôpital Carémeau

intervention_type: Biological


title: Evaluation of the Containment Impact Linked to the Covid-19 Pandemic in a Population of Parkinson Patients

acronym: ERCO-Park

summary:
The consequences of COVID-19 in these already fragile patients should be evaluated. It will be important to appreciate the confinement consequences imposed on the patient on the course and impact of the disease.

These consequences can be assessed by the end of confinement and 6 months after the latter is lifted.

ReferenceCitation: Fabbri M, Leung C, Baille G, Béreau M, Brefel Courbon C, Castelnovo G, Carriere N, Damier P, Defebvre L, Doe de Maindreville A, Fluchere F, Fuzzatti M, Grabli D, Maltete D, Rousseau V, Sommet A A, Thalamas C, Thiriez C, Rascol O, Ory-Magne F. A French survey on the lockdown consequences of COVID-19 pandemic in Parkinson's disease. The ERCOPARK study. Parkinsonism Relat Disord. 2021 Aug;89:128-133. doi: 10.1016/j.parkreldis.2021.07.013. Epub 2021 Jul 13.

lead_sponsor: University Hospital, Toulouse

location_facility: Centre Hospitalier Universitaire de la Pitié-Salpêtrière

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Centre Hospitalier Universitaire de Nîmes - Caremeau

location_facility: Centre Hospitalier Universitaire de Marseille

location_facility: Centre Hospitalier Régionale Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de Reims


title: Amplatzer™ Trevisio™ Delivery System Post-Approval Study

acronym: Trevisio PAS

summary: A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices

lead_sponsor: Abbott Medical Devices

location_country: Poland Spain Italy Netherlands Switzerland France Germany

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: Centre Médico Chirurgical Marie Lannelongue

location_facility: Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca ul.

location_facility: Fondazione Toscana Gabriele Monasterio Via Aurelia Sud

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

location_facility: Hopital Cardiovasculaire et Pneumologique Louis Pradel

location_facility: Hospital Universitario de la Paz - Pediatrico

location_facility: The Cardinal Stefan Wyszynski Institute of Cardiology


status: Terminated

acronym: ICING

title: A Phase II Trial Assessing Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in a Pre-operative Setting for Resectable and Untreated Head and Neck Squamous Cell Carcinoma

lead_sponsor: UNICANCER

source: euctr

ReferenceType: derived

ReferenceCitation: Saint A, Van Obberghen-Schilling E. The role of the tumor matrix environment in progression of head and neck cancer. Curr Opin Oncol. 2021 May 1;33(3):168-174. doi: 10.1097/CCO.0000000000000730. Review.

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:
CHU La Timone
Gustave Roussy Cancer Campus
Centre Antoine Lacassagne
Centre Léon Bérard
Institut Claudius Régaud
CHU de Bordeaux
Institut Curie
Institut de cancérologie de Lorraine

summary:
This study is a prospective open label, multicenter, phase II, window-of-opportunity preoperative, single-agent trial.

This study aims to evaluate the efficacy, the safety and tolerability profile of bintrafusp alfa in patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, previously untreated, with indication of primary surgery. Patients with a diagnosis of head and neck squamous cell carcinoma (HNSCC) from unknown primary will not be enrolled.


title: Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context

acronym: RHUMAJICOVID

summary: The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Juvenile Idiopathic Arthritis is concerns by these fears (the patient and their parents). Patients are treated by several classes of immunomodulatory drugs, including non-steroidal anti-inflammatory drugs, corticosteroids and disease modifying anti-rheumatic drugs. The present study will characterize this issue by defining the proportion of patients whose usual treatment of Juvenile Idiopathic Arthritis has been modified in relation to the actual sanitary crisis, and also to return to school.

lead_sponsor: University Hospital, Brest

location_facility:
CHU de Poitiers
CHRU de Brest
CHU de Strasbourg
AP-HP Hôpital Kremlin-Bicêtre
CHU de Bordeaux
CH de Belfort
CHU de Nancy
CHU de Rennes


title: TROPHAMET, a Phase I/II Trial of Avelumab and METhotrexate in Low-risk Gestational TROPHoblastic Neoplasias as First Line Treatment

acronym: TROPHAMET

summary:
Gestational trophoblastic neoplasias (GTN) are characterized by the persistence of elevated hCG titers after complete uterine evacuation of a partial hydatidiform mole (PHM) or a complete hydatidiform mole.

Low-risk GTN patients (FIGO score ≤ 6) are commonly treated with single agent treatment (methotrexate or actinomycin-D) The cure rate, assessed by hCG normalization, is obtained in 65 to 75% of patients with these agents GTN patients with resistance to these treatments are treated with another single agent drug or polychemotherapy regimens, such as EMA-CO or BEP regimen.

Chemotherapy standard regimens are old and toxic for these young lady patients, with potential long term effects detrimental for further maternity and quality of life

There is a strong rational for investigating the anti-PDL1 monoclonal antibody avelumab in chemoresistant GTN patients. Several elements suggest that the normal pregnancy immune tolerance is "hijacked" by GTN cell for proliferating :

Spontaneous regressions of metastastic GTN are regularly observed, thereby the role of immune system for rejecting GTN cells.
Strong and constant overexpression of PDL1 and NK cells has been found in all subtypes and settings of GTN tumors from French reference gestational trophoblastic center.
Complete and durable responses to pembrolizumab were reported in 3 patients with multi-chemoresistant GTN in United Kingdom.
Three cases of hCG normalization with avelumab in 6 patients with chemo-resistant GTN enrolled in TROPHIMMUN cohort A (resistant to a mono-chemotherapy).
Cytotoxicity of avelumab is mediated through antibody dependent cell cytotoxicity (ADCC) by NK cells.

location_facility:
Institut Bergonié
Centre Antoine Lacassagne
Assistance Publique Hôpitaux de Paris
Centre Oscar Lambret
Institut Paoli-Calmettes
Centre Hospitalier Lyon Sud
Centre Eugène Marquis
Centre François Baclesse


title: Study of the Kinetics of the Immune Response During the Intensive Care Unit Stay in Adult Patients Infected With SARS-CoV-2: Multicentric Non Interventional Study

acronym: RICO

summary:
Infection with the SARS-CoV-2 coronavirus (COVID-19) has recently been identified as a pandemic due to the speed and global scale of its transmission. In Auvergne-Rhône-Alpes region (AURA), the epidemic began in February 2020 and the number of infected people is still important. Between 15 and 20% of COVID-19 patients develop an acute respiratory distress syndrome (ARDS) leading to their hospitalization in intensive care. Their clinical progression can be rapidly harmful with the development of severe ARDS associated with an increased risk of death.

Preliminary data on the immune response of COVID-19 patients describe the induction of a moderate inflammatory response and the occurrence of major progressive lymphopenia over time associated with potential immunosuppression. Up to 50% of secondary infections are reported in deceased COVID-19 patients. However, no prospective study has exhaustively described the kinetics of the immune response of COVID-19 patients in intensive care.

The precise description of the immune response over time in adult patients with a proven infection with the SARS-CoV-2 virus and the study of the relation between this response and the increased risk of organ failure (severe ARDS), death or nosocomial infection will allow us to better understand the pathophysiology of the immune response induced by COVID-19 in order to (i) identify new therapeutic strategies targeting the host response in patients in intensive care (ii) to develop biological markers to stratify patients for future clinical trials evaluating these immunoadjuvant treatments in COVID-19.

ReferenceCitation: Bidar F, Hamada S, Gossez M, Coudereau R, Lopez J, Cazalis MA, Tardiveau C, Brengel-Pesce K, Mommert M, Buisson M, Conti F, Rimmelé T, Lukaszewicz AC, Argaud L, Cour M, Monneret G, Venet F; RICO Study Group. Recombinant human interleukin-7 reverses T cell exhaustion ex vivo in critically ill COVID-19 patients. Ann Intensive Care. 2022 Mar 5;12(1):21. doi: 10.1186/s13613-022-00982-1. Erratum in: Ann Intensive Care. 2022 Apr 1;12(1):30.

location_facility: Centre hospitalier universitaire de Grenoble Alpes


title: Chronic Fatigue Etiology and Recovery in Covid-19 Patients : the Role of Fatigability and Stay in Intensive Care

summary:
Chronic fatigue is the most common and debilitating symptom in intensive care unit (ICU) survivors. Indeed, it has been widely reported that patients who stayed in ICU for prolonged periods report a feeling of tiredness for months to years after ICU discharge. This symptom seems particularly pronounced in Covid-19 patients and may affect their quality of life by decreasing their capacity to perform simple tasks of daily life.

The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in the feeling of fatigue of Covid-19 patients. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology and its recovery will allow to optimize rehabilitation treatments to shorten the persistence of chronic fatigue and in fine improve life quality.

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Hôpital Henry Gabrielle
Hôpital Croix Rousse - HCL
Clinique Mutualiste Saint Etienne
Hôpital privé de la Loire
CHU de Grenoble
Chu Saint-Etienne
Centre Hospitalier de Lyon Sud
Clinique de la Sauvegarde - Lyon


acronym: PREP-COVID

title: Randomized Multicenter Study Evaluating the Efficacy of Azithromycin and Hydroxychloroquine in the Prevention of SARS-CoV-2 Infection in the Hospital Population Exposed to Virus

location_facility:
Hôpital Saint Antoine
Hôpital La Pitié-Salpétrière
Hôpital GHU Paris Saclay
Hôpital Cochin
Hopial Avicenne
Hôpital Broca
Hôpital européen Georges Pompidou
Hôpital Necker

summary: The Investigators propose to set up a preventive trial of infection in hospital workers at risk of coronavirus infection by comparing the rate of SARS-Cov-2 infection in a population of negative SARS-Cov-2 hospital workers receiving preventively azithromycin, hydroxychloroquine or a Placebo


type: Registry Identifier

title: Prospective Evaluation of a Predictive Toxicity Test Post Radiotherapy After Mastectomy With Immediate Implant Reconstruction

acronym: PRETORIA

summary: This study evaluates the capacity of the NovaGray RILA Breast® test to predict the toxicity linked to radiotherapy and the impact of implant breast reconstruction.

ReferenceCitation: Nègre G, Balcaen T, Dast S, Sinna R, Chazard E. Breast reconstruction in France, observational study of 140,904 cases of mastectomy for breast cancer. Ann Chir Plast Esthet. 2020 Feb;65(1):36-43. doi: 10.1016/j.anplas.2019.07.014. Epub 2019 Aug 2.

ReferenceCitation: Ng SK, Hare RM, Kuang RJ, Smith KM, Brown BJ, Hunter-Smith DJ. Breast Reconstruction Post Mastectomy: Patient Satisfaction and Decision Making. Ann Plast Surg. 2016 Jun;76(6):640-4. doi: 10.1097/SAP.0000000000000242.

ReferenceCitation: Howes BH, Watson DI, Xu C, Fosh B, Canepa M, Dean NR. Quality of life following total mastectomy with and without reconstruction versus breast-conserving surgery for breast cancer: A case-controlled cohort study. J Plast Reconstr Aesthet Surg. 2016 Sep;69(9):1184-91. doi: 10.1016/j.bjps.2016.06.004. Epub 2016 Jun 18.

ReferenceCitation: Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717.

ReferenceCitation: Ricci JA, Epstein S, Momoh AO, Lin SJ, Singhal D, Lee BT. A meta-analysis of implant-based breast reconstruction and timing of adjuvant radiation therapy. J Surg Res. 2017 Oct;218:108-116. doi: 10.1016/j.jss.2017.05.072. Epub 2017 Jun 15. Review.

ReferenceCitation: Barry M, Kell MR. Radiotherapy and breast reconstruction: a meta-analysis. Breast Cancer Res Treat. 2011 May;127(1):15-22. doi: 10.1007/s10549-011-1401-x. Epub 2011 Feb 20. Review.

location_facility:
centre Antoine Lacassagne
Institut du Cancer de Montpellier
Institut Paoli Calmette
Institut de Cancérologie de l'Ouest
Centre Léon Bérard
Centre Oscar Lambret
Hôpital Tenon
Institut Claudius Regaud


title: Cardiovascular Complications in Patients With COVID-19

acronym: CovCardioVasc

summary: Patients with COVID-19 in the Intensive Care Unit (ICU) or hospitalized with severe form have a poor prognosis (almost 30% rate of death). They present often a high cardiovascular risk profile (almost 30% of hypertension and 19% of diabetes). Troponin has been described to be elevated in a high proportion of patients (one fifth of all patients and 50% of non-survivors) suggesting the possibility of cardiomyopathies. High levels of DDimers (81% of non survivors) and fibrin degradation products are also associated with increased risk of mortality suggesting also the possibility of venous thromboembolism. Therefore, screening for cardiomyopathies and venous thromboembolism could represent an important challenge for patients with COVID-19 management.

ReferenceCitation: Ferrari E, Sartre B, Squara F, Contenti J, Occelli C, Lemoel F, Levraut J, Doyen D, Dellamonica J, Mondain V, Chirio D, Risso K, Cua E, Orban JC, Ichai C, Labbaoui M, Mossaz B, Moceri P, Appert-Flory A, Fischer F, Toulon P. High Prevalence of Acquired Thrombophilia Without Prognosis Value in Patients With Coronavirus Disease 2019. J Am Heart Assoc. 2020 Nov 3;9(21):e017773. doi: 10.1161/JAHA.120.017773. Epub 2020 Sep 25.

ipd_sharing_description: no data sharing plan has been established.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Hôpitaux Universitaires Paris Centre - Hôpital Cochin


title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Tocilizumab Trial - CORIMUNO-19 - TOCI (CORIMUNO-TOCI)

acronym: CORIMUNO-TOC

summary: The overall objective of the study is to determine the therapeutic effect and tolerance of Tocizilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Tocilizumab administration to patients enrolled in the COVIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.

ReferenceCitation: Tleyjeh IM. The Misleading "Pooled Effect Estimate" of Crude Data from Observational Studies at Critical Risk of Bias: The Case of Tocilizumab in Coronavirus Disease 2019 (COVID-19). Clin Infect Dis. 2021 Jun 15;72(12):e1154-e1155. doi: 10.1093/cid/ciaa1735.

ReferenceCitation: Hermine O, Mariette X, Tharaux PL, Resche-Rigon M, Porcher R, Ravaud P; CORIMUNO-19 Collaborative Group. Effect of Tocilizumab vs Usual Care in Adults Hospitalized With COVID-19 and Moderate or Severe Pneumonia: A Randomized Clinical Trial. JAMA Intern Med. 2021 Jan 1;181(1):32-40. doi: 10.1001/jamainternmed.2020.6820. Erratum in: JAMA Intern Med. 2021 Jan 1;181(1):144. Erratum in: JAMA Intern Med. 2021 Jul 1;181(7):1021.

ipd_sharing: Undecided

location_facility:
APHP - Pitié Salpêtrière
APHP - Beaujon
APHP- Hopital Tenon
APHP - Saint Louis
CHU Strasbourg
Institut Gustave Roussy
APHP - Hopital Necker
APHP - Bichat


title: OP2C : Prialt® Observatory in Clinical Practice

summary: Ziconotide (Prialt®) is a powerful analgesic, approved in Europe since 2005, and reserved for the intrathecal route. Ziconotide is a protein of 2500 Daltons isolated from a cone-snail: Conus Magus, acting by blocking the N-type voltage-sensitive calcium channels. Its efficacy has been proven by 3 randomized clinical trials. It is particularly effective on chronic refractory neuropathic pain, and its main advantages are its power of action, the absence of bone marrow toxicity, and the absence of respiratory depression. In addition, there were no signs of withdrawal when stopping the drug, or of tachyphylaxis. However, during these studies many adverse reactions became evident, especially neuropsychiatric reactions, which limited its use. This toxicity was mainly related to the administration of too high doses, especially at the start of treatment. There is a lack of data on the current use of ziconotide in current practice. The objective of the study will be to describe the practical methods of using intrathecal treatments containing ziconotide in different settings of patients with severe chronic pain requiring intrathecal analgesia.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Centre Hospitalier Departemental La Roche Sur Yon


title: Management of Anticoagulant Therapy Monitored by an Implantable Device With Telecardiology in Patients With Acute Coronary Syndrome Associated With de Novo Atrial Fibrillation Arrhythmia: A Prospective Multicenter Study

acronym: SCA FA

summary: Patients with Acute Coronary Syndrome associated with de novo atrial fibrillation are randomized to benefit from either a conventional therapy associating dual antiplatelet therapy (DAPT) and anticoagulant or DAPT and an implantable monitoring device with a follow-up by telecardiology

lead_sponsor: Centre Hospitalier de PAU

location_facility: Centre hospitalier Chartres Louis Pasteur le Coudray


title: Evaluation of Positioning Protocols With an Adapted Equipment on a Wheelchair in Hemiplegic Patients Following a Stroke

acronym: POSIT-HEMI

summary: The main purpose of this study is to assess the interest of using wheelchair positioning equipment on the decrease of postural disorders, compared to the standard use of a wheelchair

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre de Rééducation et de Réadaptation Fonctionnelles

location_facility: Groupement Hospitalier Intercommunal du Vexin


title: Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung : a Randomized Non Comparative Phase II Trial

acronym: Optim-UCPVax

summary:
Lung cancer is the most commonly diagnosed malignancy and the leading cause of cancer-related mortality both in men and women worldwide.

The past few years have demonstrated great progress in the field of tumor immunotherapy through agents that address mechanisms of immune escape notably, so called immune checkpoint inhibitors (ICB). Indeed, ICB have emerged as a fatal weapon in the anticancer treatment arsenal. Anti-PD-1 and anti-PD-L1 antibodies have shown promising results in several cancers including Non-small Cell Lung Cancer (NSCLC) patients. Although such ICB extend patient's survival compared with conventional systemic therapies, they fail to control cancer progression in a significant proportion of patients which can reach up to 50-60% in NSCLC. Recent literature highlights a range of factors involved in the heterogeneous responses and failures to ICB therapies. The challenge is how can ICB treatment efficacy be extended to majority patients? To respond to this question, to increase the success of immunotherapy, immuno-oncology community develops combinations approaches.

The aim of these project is to evaluate the efficacy of Nivolumab plus a novel CD4Th1 inducer anti-cancer vaccine in NSCLC patients.

Nivolumab (NIVO), which is an anti-PD-1 antibody, has shown promising results in 2nd line treatment for advanced NSCLC.

UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).

ReferenceCitation: Adotévi O, Dosset M, Galaine J, Beziaud L, Godet Y, Borg C. Targeting antitumor CD4 helper T cells with universal tumor-reactive helper peptides derived from telomerase for cancer vaccine. Hum Vaccin Immunother. 2013 May;9(5):1073-7. doi: 10.4161/hv.23587. Epub 2013 Jan 28. Review.

ReferenceCitation: Godet Y, Dosset M, Borg C, Adotevi O. Is preexisting antitumor CD4 T cell response indispensable for the chemotherapy induced immune regression of cancer? Oncoimmunology. 2012 Dec 1;1(9):1617-1619.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Institut de Cancérologie Privé CCGM
Centre Georges François Leclerc
Institut Jean Godinot
CH Mulhouse
CHU Bordeaux
Institut de Cancérologie de l'Ouest
CHU of Besançon
CHU de Nîmes


status: Active, not recruiting

acronym: COLIBRI

title: A Multicenter, Pilot Study Evaluating Immune Impact and Safety of Nivolumab in Combination With Ipilimumab (Immune Combination) Before Initial RT-CT Treatment for Cervix Cancer.: the French GINECO - COLIBRI Study

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Groupe Hospitalier Diaconesses - Croix Saint-Simon

location_facility: Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie, CARIO-HPCA

summary: This is a multicenter, single arm pilot study evaluating the biological impact of "Nivolumab + Ipilimumab" in patients with cervical squamous cell carcinoma requiring RT-CT as initial therapy


title: Switch to Tenofovir Alafenamide (TAF), Emtricitabine (FTC), Bictegravir (BIC)(Biktarvy®) in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication

acronym: BICOLDER

summary: Patients infected and living with HIV are getting older and have more and more non-HIV co-morbidities. These expose them to polypharmacy that increases the risk of pharmacological interaction. Bictegravir, co-formulated with emtricitabine (FTC) and tenofovir alafenamide (TAF) (BIKTARVY) a new generation integrase inhibitor with a high genetic barrier and had no drug interaction may be a treatment of choice for participant over 65 years old who are HIV infected . BIKTARVY improve adherence and quality of life; and on the other hand it would limit the risks of pharmacological interaction. In addition, the use of TAF reducing the risk of long-term renal toxicity and adverse effects on bone would be of interest in this aging population and more at risk of osteoporosis.

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

location_facility:
Hopital Hotel Dieu
Hopital Bretonneau
Hopital Gustave Dron
Hôpital Hotel Dieu
Bichat Hospital
Hopital Sainte Marguerite
Hopital L'Archet
CH de Saint Nazaire


title: A Phase II Study Assessing Safety and Efficacy of Cabozantinib for Advanced or Metastatic Cervical Carcinoma After Platinum Treatment Failure

summary: Assess efficacy and safety of cabozantinib in monotherapy in advanced/metastatic cervical cancer (CC) after failure of platinum-based regimen treatment.

ReferenceCitation: Coquan E, Brachet PE, Licaj I, Leconte A, Castera M, Lequesne J, Meriaux E, Bonnet I, Lelaidier A, Clarisse B, Joly F. CABOCOL-01 trial: a single-arm phase II study assessing safety and efficacy of Cabozantinib for advanced or metastatic cervical carcinoma after platinum treatment failure. BMC Cancer. 2021 Sep 25;21(1):1054. doi: 10.1186/s12885-021-08758-9.

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Oscar LAMBRET
Centre Léon Bérard
Institut CURIE
Institut de Cancérologie de Montpellier
Institut Gustave Roussy
Institut de cancérologie de l'Ouest
Centre François Baclesse


title: A Multicentre, Comparative, Placebo-controlled, Double-blinded, Phase II Study of the Efficacy of Lenvatinib in Patients With Locally Advanced or Metastatic GIST After Failure of Imatinib and Sunitinib

acronym: LENVAGIST

summary: The primary objective is to compare the efficacy of lenvatinib plus Best Supportive Care versus Placebo plus Best Supportive Care in the treatment of patients with advanced GIST, after failure of imatinib and sunitinib.

lead_sponsor: Centre Leon Berard

location_facility:
Institut Bergonié
Institut Paoli Calmette
Centre Léon Bérard
Centre Georges-François Leclerc
ICO Centre René Gauducheau
CHU de Reims
Hopital de La Timone
Institut Gustave Roussy


title: Precision Medicine Phase II Study Evaluating the Efficacy of a Double Immunotherapy by Durvalumab and Tremelimumab Combined With Olaparib in Patients With Solid Cancers and Carriers of Homologous Recombination Repair Genes Mutation in Response or Stable After Olaparib Treatment

summary: The study propose to generate a clinical trial based on precision medicine to evaluate the use of immunotherapy in patients with altered homologous recombination repair genes and without progression after prior targeted therapy.

ReferenceCitation: Fumet JD, Limagne E, Thibaudin M, Truntzer C, Bertaut A, Rederstorff E, Ghiringhelli F. Precision medicine phase II study evaluating the efficacy of a double immunotherapy by durvalumab and tremelimumab combined with olaparib in patients with solid cancers and carriers of homologous recombination repair genes mutation in response or stable after olaparib treatment. BMC Cancer. 2020 Aug 10;20(1):748. doi: 10.1186/s12885-020-07253-x.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
Institut Bergonié
CHRU Jean Minjoz
Centre Georges François Leclerc
Centre Oscar Lambret
CHU François Mitterrand
Institut Hospitalier Franco-Britannique
Centre Leon Berard
CHU Amiens


title: Impact of a Strategy Combining the Rapid Polymerase Chain Reaction Platform FilmArray® and the Intervention of an Antimicrobial Stewardship Team in Hospital-acquired Pneumonia in Non-mechanically Ventilated Patients: a Randomized Controlled Trial.

acronym: SHARP

summary:
Hospital-Acquired Pneumonia (HAP) is the second most frequent hospital-acquired infection in the US and Europe and accounts for a large proportion of antibiotics prescribed in hospitals. Conventional methods to identify causative microorganisms (virus, bacteria) are time-consuming and sometimes inaccurate, leading to inadequate treatment in a large proportion of HAP patients.

The FILMARRAY® Pneumonia Panel (FA-PP, bioMérieux) is an automated diagnostic device, allowing detection of multiple pathogens and resistance markers in one hour. Strategies combining rapid diagnostic testing and intervention of specialists in infectious diseases (i.e. antimicrobial stewardship -AMS - experts) showed significant synergistic impact on antibiotic use, mortality and costs in bloodstream infections.

The trial hypothesis is that a strategy combining antimicrobial stewardship and FA-PP improves quality of care in HAP patients, as compared to antimicrobial stewardship alone.

The trial will include patients hospitalized for ≥ 48 hours, aged 18 years or older, who have criteria of pneumonia: new lung infiltrate on a chest-x ray, plus evidence that the infiltrate is of an infectious origin (i.e. new onset of fever and/or purulent sputum and/or leukocytosis and/or decline in oxygenation).

After informed consent, participants will be randomly allocated to either the intervention or the control arm.

In the control arm, management of HAP patients will include clinical examination and conventional microbiological tests. Antibiotic choice will be discussed between AMS experts and the physician in charge of the patient.

In the intervention arm, in addition to the procedures above, the strategy will include rapid testing using the FA-PP on a respiratory specimen, obtained by either invasive or non-invasive sampling. No additional invasive procedures will be required for the study, and FA-PP will be performed on samples collected as part as routine care.

Investigators will visit the patient at inclusion, on day 3 and on day 30 (or at hospital discharge) to collect data on comorbidities, clinical outcomes, results of microbiological tests and antibiotics. At the end of follow-up, we will compare the number of days on broad-spectrum antibiotics, the incidence of negative outcomes, the length of stay and costs in the two arms.

The use of the FA-PP is expected to prompt early adjustment of antibiotic therapy, improve outcomes, decrease length of stay, and to reduce the use of broad-spectrum antibiotics. The antibiotic saving may reduce the selection pressure, incidence of colonization with multidrug-resistant bacteria and incidence of hospital-acquired superinfections, both at an individual and hospital level. Moreover, this trial relies on the intervention of multidisciplinary AMS teams that are currently being implemented in many health facilities. Their transversal position offers opportunities for recruitment of patients from a wide range of medical and surgical departments. This project evaluates the feasibility of clinical trials based on the intervention of these teams, and will provide a high level of evidence regarding their impact on the prognosis of patients, appropriate use of antibiotics, and antimicrobial resistance.

ReferenceCitation: Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratalà J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14. Erratum in: Clin Infect Dis. 2017 May 1;64(9):1298. Erratum in: Clin Infect Dis. 2017 Oct 15;65(8):1435. Clin Infect Dis. 2017 Nov 29;65(12):2161.

ReferenceCitation: Messika J, Stoclin A, Bouvard E, Fulgencio JP, Ridel C, Muresan IP, Boffa JJ, Bachmeyer C, Denis M, Gounant V, Esteso A, Loi V, Verdet C, Prigent H, Parrot A, Fartoukh M. The Challenging Diagnosis of Non-Community-Acquired Pneumonia in Non-Mechanically Ventilated Subjects: Value of Microbiological Investigation. Respir Care. 2016 Feb;61(2):225-34. doi: 10.4187/respcare.04143. Epub 2015 Dec 8.

ReferenceCitation: Gadsby NJ, Russell CD, McHugh MP, Mark H, Conway Morris A, Laurenson IF, Hill AT, Templeton KE. Comprehensive Molecular Testing for Respiratory Pathogens in Community-Acquired Pneumonia. Clin Infect Dis. 2016 Apr 1;62(7):817-823. doi: 10.1093/cid/civ1214. Epub 2016 Jan 7.

ReferenceCitation: Davey P, Marwick CA, Scott CL, Charani E, McNeil K, Brown E, Gould IM, Ramsay CR, Michie S. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev. 2017 Feb 9;2:CD003543. doi: 10.1002/14651858.CD003543.pub4. Review.

ReferenceCitation: Bookstaver PB, Nimmich EB, Smith TJ 3rd, Justo JA, Kohn J, Hammer KL, Troficanto C, Albrecht HA, Al-Hasan MN. Cumulative Effect of an Antimicrobial Stewardship and Rapid Diagnostic Testing Bundle on Early Streamlining of Antimicrobial Therapy in Gram-Negative Bloodstream Infections. Antimicrob Agents Chemother. 2017 Aug 24;61(9). pii: e00189-17. doi: 10.1128/AAC.00189-17. Print 2017 Sep.

ReferenceCitation: Kerneis S, Visseaux B, Armand-Lefevre L, Timsit JF. Molecular diagnostic methods for pneumonia: how can they be applied in practice? Curr Opin Infect Dis. 2021 Apr 1;34(2):118-125. doi: 10.1097/QCO.0000000000000713. Review.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpitaux Universitaires Paris Nord Val de Seine-Site Bichat (SMIT)

location_facility: Hôpitaux Universitaires Paris Centre-Site Cochin

location_facility: Hôpitaux Universitaires Paris Nord Val de Seine - MIR (Bichat)

location_facility: Hôpitaux Universitaires Paris Nord Val de Seine - EPRI (Bichat)

location_facility: Hôpitaux Universitaires Paris Centre (Cochin) - service Médecine Intensive - Réanimation


title: Effect of a Tailored Program of Physical Activity and Nutritional Therapeutic Education on Clinical, Psychological and Sociological Factors in Breast Cancer Patients Undergoing Adjuvant Treatment : Multicenter Randomized Controlled Trial

summary: This multicenter randomized controlled trial aims to evaluate the effect of a tailored program of physical activity and nutritional therapeutic education on clinical, psychological and sociological factors in breast cancer patients undergoing adjuvant treatment.

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

location_facility:
ICM
Centre Léon Bérard
Centre Oscar Lambret
CH Montélimar
CH Ambroise Paré
Institut de Cancéologie de l'Ouest
Centre Eugène Marquis
Institut Sainte Catherine


title: A Phase IIa Multi-Center, Randomized, Single-Blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation

lead_sponsor: Zambon SpA

location_country: Germany France Spain

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

location_facility: Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

summary:
Primary Objective:

The primary objective of this study is to assess the tolerability and safety of two dose levels of aerosolized L-CsA vs placebo in addition to SoC therapy for BOS in adult allo-HSCT recipients.

Secondary Objectives:

The secondary objectives of this study are to assess PK and exploratory efficacy and quality of life of two dose levels of aerosolized L-CsA vs placebo in addition to SoC therapy for BOS in adult allo-HSCT recipients.


title: BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR Study)

acronym: BACHELOR

summary:
Patients with recent PMR(6 months or less) with a PMR-AS >17 and no oral or parenteral GCs during the past 2 weeks (at least) will be included.

Treatment with oral baricitinib 4mg or placebo during 12 weeks and then, if PMR-AS≤10, they will receive baricitinib 2 mg for 12 weeks and then will stop treatment.

No rescue is allowed before week 4 (visit 3) but patients may receive up to 2 intra-articular or soft tissue injections of GCs until week 4 according to investigator's opinion.

From week 4 to week 12, steroids will be proposed as a rescue for both arms at investigators' discretion and according to PMR-AS.

location_facility:
CHU Strasbourg
Chu Bordeaux
CHU Brest
CHU Montpellier
CH Le Mans
Chu Tours
Ch Morlaix
CHU Nice


title: Endoscopic Ultrasound Guided Choledocoduodenostomy With the Lumen Apposing Metal Stent [Axios® Stent]

summary: Endoscopic Ultrasound (EUS) guided biliary drainage is indicated in case of impossibility or failure of classic biliary drainage by endoscopic retrograde cholangio-pancreatography (ERCP). Recently the investigators reported a good efficiency of EUS guided choledocoduodenostomy using the HOT-AXIOS device (Electrocautery enhanced lumen apposing metal stent) in a retrospective multicentric study. Utilization of the recommended technique (direct punction with the HOT AXIOS using a pure cut current + using a 6 mm Stent) was the only predicting factor of clinical success. The investigators reevaluate this procedure one year after in the same centers.

lead_sponsor: University Hospital, Limoges

location_facility:
APHM Hospital La Timone
Hospital Cournouaille
Hospital Private Jean MERMOZ
University Hospital
APHP Hospital Saint-Antoine
Hospital University
Hospital Jacques Lacarin


title: A Reactogenicity, Safety and Immunogenicity Study of GSK's Paediatric Herpes Zoster Subunit Candidate Vaccine (PED-HZ/su) GSK143713A in Immunocompromised Paediatric Renal Transplant Recipients

lead_sponsor: GlaxoSmithKline

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
United Kingdom
France
Spain
Italy

summary: The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of 2 doses of PED-HZ/su, GSK's vaccine candidate for the prevention of Herpes Zoster (HZ) in immunocompromised paediatric renal transplant recipients aged 1-17 years


title: End-ischemic Hypothermic Oxygenated Perfusion for Extended Criteria Donors in Liver Transplantation - A Multicenter, Randomized Controlled Trial

acronym: HOPExt

summary:
Given the scarce donor supply, an increasing number of so-called marginal or extended criteria donor (ECD) organs have been used for liver transplantation. These ECD liver grafts are, however, known to be associated with a higher rate of early allograft dysfunction (EAD) and primary non-function because of a greater vulnerability to ischemia-reperfusion injury. The end-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE) technique may improve outcomes of liver transplantation with ECD grafts by decreasing reperfusion injury.

The study aim is to assess the efficacy of HOPE used before transplantation of ECD liver grafts from brain-dead donors in reducing postoperative EAD within the first 7 postoperative days (POD) compared to simple cold static storage.

The study is comparative open-label, multicenter, national, prospective, randomized, in two parallel groups, using the gold standard procedure as control.

ReferenceCitation: Olthoff KM, Kulik L, Samstein B, Kaminski M, Abecassis M, Emond J, Shaked A, Christie JD. Validation of a current definition of early allograft dysfunction in liver transplant recipients and analysis of risk factors. Liver Transpl. 2010 Aug;16(8):943-9. doi: 10.1002/lt.22091.

ReferenceCitation: Pareja E, Cortes M, Hervás D, Mir J, Valdivieso A, Castell JV, Lahoz A. A score model for the continuous grading of early allograft dysfunction severity. Liver Transpl. 2015 Jan;21(1):38-46. doi: 10.1002/lt.23990. Epub 2014 Nov 24.

ReferenceCitation: Agopian VG, Harlander-Locke MP, Markovic D, Dumronggittigule W, Xia V, Kaldas FM, Zarrinpar A, Yersiz H, Farmer DG, Hiatt JR, Busuttil RW. Evaluation of Early Allograft Function Using the Liver Graft Assessment Following Transplantation Risk Score Model. JAMA Surg. 2018 May 1;153(5):436-444. doi: 10.1001/jamasurg.2017.5040. Erratum in: JAMA Surg. 2018 May 1;153(5):498.

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of HPB surgery and liver transplantation Pontchaillou University Hospital

location_facility: Hôpital Hautepierre - Department of HPB surgery and liver transplantation

location_facility: CHU Grenoble Alpes - Department of HPB surgery and liver transplantation

location_facility: Department of HPB surgery and liver transplantation Claude Huriez University Hospital

location_facility: Department of HPB surgery and liver transplantation Beaujon University Hospital

location_facility: Department of HPB surgery and liver transplantation Paul Brousse University Hospital


title: Pronostic Assessment of Mortality Among Locally Advanced or Metastatic Renal Cell Carcinoma Patients After First Line Treatment : Multicenter Prospective Cohort Study With Historic Medical Data

acronym: MERLIN

summary:
The hypothesis of this study are as follows:

Prognostic evaluation of patients based on an integrative model provides better assessment of overall survival, and thus improves setting of care goals.
In a routine care population, antitumour drugs may have a significant impact on overall survival through their targeted antitumor effect, but also through their toxicity profile and their impact on comorbidities.
The optimization of patient support (supportive care, drug tolerance monitoring) can have an impact on the prognosis.

location_facility: Hôpital d'Instruction des Armées de Bégin


acronym: Pen ASAP

title: Multicentre, Randomised, Double-blind Study Assessing the Efficacy and Safety of Penthrox® Combined With a Standard Analgesia (SoC) in Comparison to a Placebo Combined With a Standard Analgesia (SoC) in Adult Patients Admitted to the Emergency Department With Moderate to Severe Pain Associated With Trauma

lead_sponsor: Mundipharma SAS

location_facility:
CHU Purpan
Hôpital Edouard Herriot
Hospice civil de Lyon
CH Annecy Genevois
GH Carnelle Porte de l'Oise
CH René Dubos
Hôpital Avicenne - APHP
CHRU Lille

summary: A phase 4 randomised, double-blind study to assess the efficacy and safety of Penthrox® used from the outset in multimodal analgesia, in combination with the standard analgesic protocol used in the department, for conscious adult patients presenting in an emergency department with moderate to severe pain associated with a trauma


title: Effectiveness of the RemedRugby Program, a Program of Ecological Cognitive Remediation of Social Cognition Disorders in Schizophrenia

acronym: RemedRugby

summary:
REMEDRUGBY's objective is to strengthen the capacity of users to interact with others in an assertive way and to fight against stigma. It proposes to specifically target the processes of "social cognition".

"Social cognition" brings together the mental mechanisms that allow everyone to decipher the social situations, emotions and intentions of others and interact with others in the different contexts of everyday life.

People with a psychic handicap frequently have difficulties in this area, which has often important consequences for their social and professional integration.

The REMEDRUGBY program proposes to work specifically on these processes in the context of sport (+ role Play and blog) to strengthen the ability to interact with others and to deal with the stigma that can be encountered on a daily basis.

ReferenceCitation: Abu-Akel A. A neurobiological mapping of theory of mind. Brain Res Brain Res Rev. 2003 Sep;43(1):29-40. Review.

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ReferenceCitation: Bellack AS, Brown SA. Psychosocial treatments for schizophrenia. Curr Psychiatry Rep. 2001 Oct;3(5):407-12. Review.

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ReferenceCitation: Bengtsson-Tops A. Mastery in patients with schizophrenia living in the community: relationship to sociodemographic and clinical characteristics, needs for care and support, and social network. J Psychiatr Ment Health Nurs. 2004 Jun;11(3):298-304.

ReferenceCitation: Bertrand MC, Sutton H, Achim AM, Malla AK, Lepage M. Social cognitive impairments in first episode psychosis. Schizophr Res. 2007 Sep;95(1-3):124-33. Epub 2007 Jul 16.

ReferenceCitation: Blair RJ. Responding to the emotions of others: dissociating forms of empathy through the study of typical and psychiatric populations. Conscious Cogn. 2005 Dec;14(4):698-718. Epub 2005 Sep 12. Review.

ReferenceCitation: Blanchard JJ, Mueser KT, Bellack AS. Anhedonia, positive and negative affect, and social functioning in schizophrenia. Schizophr Bull. 1998;24(3):413-24.

ReferenceCitation: Bora E, Yucel M, Pantelis C. Theory of mind impairment in schizophrenia: meta-analysis. Schizophr Res. 2009 Apr;109(1-3):1-9. doi: 10.1016/j.schres.2008.12.020. Epub 2009 Feb 4.

ReferenceCitation: Ritsher JB, Otilingam PG, Grajales M. Internalized stigma of mental illness: psychometric properties of a new measure. Psychiatry Res. 2003 Nov 1;121(1):31-49.

ReferenceCitation: Brohan E, Elgie R, Sartorius N, Thornicroft G; GAMIAN-Europe Study Group. Self-stigma, empowerment and perceived discrimination among people with schizophrenia in 14 European countries: the GAMIAN-Europe study. Schizophr Res. 2010 Sep;122(1-3):232-8. doi: 10.1016/j.schres.2010.02.1065. Epub 2010 Mar 26.

ReferenceCitation: Brüne M. "Theory of mind" in schizophrenia: a review of the literature. Schizophr Bull. 2005 Jan;31(1):21-42. Epub 2005 Feb 16. Review.

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ReferenceCitation: Choi J, Fiszdon JM, Medalia A. Expectancy-value theory in persistence of learning effects in schizophrenia: role of task value and perceived competency. Schizophr Bull. 2010 Sep;36(5):957-65. doi: 10.1093/schbul/sbq078. Epub 2010 Jul 15.

ReferenceCitation: Combs DR, Adams SD, Penn DL, Roberts D, Tiegreen J, Stem P. Social Cognition and Interaction Training (SCIT) for inpatients with schizophrenia spectrum disorders: preliminary findings. Schizophr Res. 2007 Mar;91(1-3):112-6. Epub 2007 Feb 12.

ReferenceCitation: Corcoran R, Mercer G, Frith CD. Schizophrenia, symptomatology and social inference: investigating "theory of mind" in people with schizophrenia. Schizophr Res. 1995 Sep;17(1):5-13.

ReferenceCitation: Corcoran R, Rowse G, Moore R, Blackwood N, Kinderman P, Howard R, Cummins S, Bentall RP. A transdiagnostic investigation of 'theory of mind' and 'jumping to conclusions' in patients with persecutory delusions. Psychol Med. 2008 Nov;38(11):1577-83. Epub 2007 Nov 16.

ReferenceCitation: Couture SM, Penn DL, Roberts DL. The functional significance of social cognition in schizophrenia: a review. Schizophr Bull. 2006 Oct;32 Suppl 1:S44-63. Epub 2006 Aug 17. Review.

ReferenceCitation: Couture SM, Granholm EL, Fish SC. A path model investigation of neurocognition, theory of mind, social competence, negative symptoms and real-world functioning in schizophrenia. Schizophr Res. 2011 Feb;125(2-3):152-60. doi: 10.1016/j.schres.2010.09.020. Epub 2010 Oct 20.

ReferenceCitation: Darbà J, Minoves A, Rojo E, Jimenez F, Rejas J. Efficacy of second-generation-antipsychotics in the treatment of negative symptoms of schizophrenia: a meta-analysis of randomized clinical trials. Rev Psiquiatr Salud Ment. 2011 Jul;4(3):126-43. doi: 10.1016/j.rpsm.2011.02.005. Epub 2011 Jun 14. English, Spanish.

ReferenceCitation: de Haan L, Linszen DH, Lenior ME, de Win ED, Gorsira R. Duration of untreated psychosis and outcome of schizophrenia: delay in intensive psychosocial treatment versus delay in treatment with antipsychotic medication. Schizophr Bull. 2003;29(2):341-8.

ReferenceCitation: Demily C, Franck N. Cognitive remediation: a promising tool for the treatment of schizophrenia. Expert Rev Neurother. 2008 Jul;8(7):1029-36. doi: 10.1586/14737175.8.7.1029. Review.

ReferenceCitation: Deutsch F, Madle RA. Empathy: historic and current conceptualizations, measurement, and a cognitive theoretical perspective. Hum Dev. 1975;18(4):267-87.

ReferenceCitation: Dziobek I, Rogers K, Fleck S, Bahnemann M, Heekeren HR, Wolf OT, Convit A. Dissociation of cognitive and emotional empathy in adults with Asperger syndrome using the Multifaceted Empathy Test (MET). J Autism Dev Disord. 2008 Mar;38(3):464-73. Epub 2007 Nov 8.

ReferenceCitation: Edwards J, Jackson HJ, Pattison PE. Emotion recognition via facial expression and affective prosody in schizophrenia: a methodological review. Clin Psychol Rev. 2002 Jul;22(6):789-832. Review. Erratum in: Clin Psychol Rev. 2002 Nov;22(8):1267-85.

ReferenceCitation: Fett AK, Viechtbauer W, Dominguez MD, Penn DL, van Os J, Krabbendam L. The relationship between neurocognition and social cognition with functional outcomes in schizophrenia: a meta-analysis. Neurosci Biobehav Rev. 2011 Jan;35(3):573-88. doi: 10.1016/j.neubiorev.2010.07.001. Epub 2010 Jul 8. Review.

ReferenceCitation: Jolley S, Garety P, Bebbington P, Dunn G, Freeman D, Kuipers E, Fowler D, Hemsley D. Attributional style in psychosis--the role of affect and belief type. Behav Res Ther. 2006 Nov;44(11):1597-607. Epub 2006 Jan 24.

ReferenceCitation: Frith CD. Schizophrenia and theory of mind. Psychol Med. 2004 Apr;34(3):385-9.

ReferenceCitation: Galderisi S, Bucci P, Mucci A, Kirkpatrick B, Pini S, Rossi A, Vita A, Maj M. Categorical and dimensional approaches to negative symptoms of schizophrenia: focus on long-term stability and functional outcome. Schizophr Res. 2013 Jun;147(1):157-162. doi: 10.1016/j.schres.2013.03.020. Epub 2013 Apr 19.

ReferenceCitation: Galderisi S, Mucci A, Bitter I, Libiger J, Bucci P, Fleischhacker WW, Kahn RS; Eufest Study Group. Persistent negative symptoms in first episode patients with schizophrenia: results from the European First Episode Schizophrenia Trial. Eur Neuropsychopharmacol. 2013 Mar;23(3):196-204. doi: 10.1016/j.euroneuro.2012.04.019. Epub 2012 May 28.

ReferenceCitation: Green MF, Olivier B, Crawley JN, Penn DL, Silverstein S. Social cognition in schizophrenia: recommendations from the measurement and treatment research to improve cognition in schizophrenia new approaches conference. Schizophr Bull. 2005 Oct;31(4):882-7. Epub 2005 Aug 31.

ReferenceCitation: Green MF, Penn DL, Bentall R, Carpenter WT, Gaebel W, Gur RC, Kring AM, Park S, Silverstein SM, Heinssen R. Social cognition in schizophrenia: an NIMH workshop on definitions, assessment, and research opportunities. Schizophr Bull. 2008 Nov;34(6):1211-20. doi: 10.1093/schbul/sbm145. Epub 2008 Jan 8.

ReferenceCitation: Green MF, Leitman DI. Social cognition in schizophrenia. Schizophr Bull. 2008 Jul;34(4):670-2. doi: 10.1093/schbul/sbn045. Epub 2008 May 20.

ReferenceCitation: Hardy-Baylé MC, Sarfati Y, Passerieux C. The cognitive basis of disorganization symptomatology in schizophrenia and its clinical correlates: toward a pathogenetic approach to disorganization. Schizophr Bull. 2003;29(3):459-71.

ReferenceCitation: Kalpakci A, Vanwoerden S, Elhai JD, Sharp C. The Independent Contributions of Emotion Dysregulation and Hypermentalization to the "Double Dissociation" of Affective and Cognitive Empathy in Female Adolescent Inpatients With BPD. J Pers Disord. 2016 Apr;30(2):242-60. doi: 10.1521/pedi_2015_29_192. Epub 2015 Apr 23.

ReferenceCitation: Harrington L, Siegert RJ, McClure J. Theory of mind in schizophrenia: a critical review. Cogn Neuropsychiatry. 2005 Aug;10(4):249-86.

ReferenceCitation: Harvey PD, Koren D, Reichenberg A, Bowie CR. Negative symptoms and cognitive deficits: what is the nature of their relationship? Schizophr Bull. 2006 Apr;32(2):250-8. Epub 2005 Oct 12. Review.

ReferenceCitation: Hoekert M, Kahn RS, Pijnenborg M, Aleman A. Impaired recognition and expression of emotional prosody in schizophrenia: review and meta-analysis. Schizophr Res. 2007 Nov;96(1-3):135-45. Epub 2007 Sep 4.

ReferenceCitation: Kee KS, Green MF, Mintz J, Brekke JS. Is emotion processing a predictor of functional outcome in schizophrenia? Schizophr Bull. 2003;29(3):487-97.

ReferenceCitation: Kohler CG, Bilker W, Hagendoorn M, Gur RE, Gur RC. Emotion recognition deficit in schizophrenia: association with symptomatology and cognition. Biol Psychiatry. 2000 Jul 15;48(2):127-36.

ReferenceCitation: Jones AP, Happé FG, Gilbert F, Burnett S, Viding E. Feeling, caring, knowing: different types of empathy deficit in boys with psychopathic tendencies and autism spectrum disorder. J Child Psychol Psychiatry. 2010 Nov;51(11):1188-97. doi: 10.1111/j.1469-7610.2010.02280.x.

ReferenceCitation: Lahera G, Benito A, Montes JM, Fernández-Liria A, Olbert CM, Penn DL. Social cognition and interaction training (SCIT) for outpatients with bipolar disorder. J Affect Disord. 2013 Mar 20;146(1):132-6. doi: 10.1016/j.jad.2012.06.032. Epub 2012 Jul 25.

ReferenceCitation: Lawrence EJ, Shaw P, Baker D, Patel M, Sierra-Siegert M, Medford N, David AS. Empathy and enduring depersonalization: the role of self-related processes. Soc Neurosci. 2007;2(3-4):292-306. doi: 10.1080/17470910701391794.

ReferenceCitation: Lin CH, Huang CL, Chang YC, Chen PW, Lin CY, Tsai GE, Lane HY. Clinical symptoms, mainly negative symptoms, mediate the influence of neurocognition and social cognition on functional outcome of schizophrenia. Schizophr Res. 2013 May;146(1-3):231-7. doi: 10.1016/j.schres.2013.02.009. Epub 2013 Mar 9.

ReferenceCitation: Livingston JD, Boyd JE. Correlates and consequences of internalized stigma for people living with mental illness: a systematic review and meta-analysis. Soc Sci Med. 2010 Dec;71(12):2150-61. doi: 10.1016/j.socscimed.2010.09.030. Epub 2010 Oct 12. Review.

ReferenceCitation: Lysaker PH, Beattie NL, Strasburger AM, Davis LW. Reported history of child sexual abuse in schizophrenia: associations with heightened symptom levels and poorer participation over four months in vocational rehabilitation. J Nerv Ment Dis. 2005 Dec;193(12):790-5.

ReferenceCitation: MacLeod J, Nelson G. Programs for the promotion of family wellness and the prevention of child maltreatment: a meta-analytic review. Child Abuse Negl. 2000 Sep;24(9):1127-49.

ReferenceCitation: Medalia A, Choi J. Cognitive remediation in schizophrenia. Neuropsychol Rev. 2009 Sep;19(3):353-64. doi: 10.1007/s11065-009-9097-y. Epub 2009 May 15. Review.

ReferenceCitation: Medalia A, Saperstein A. The role of motivation for treatment success. Schizophr Bull. 2011 Sep;37 Suppl 2:S122-8. doi: 10.1093/schbul/sbr063. Review.

ReferenceCitation: Medalia A, Richardson R. What predicts a good response to cognitive remediation interventions? Schizophr Bull. 2005 Oct;31(4):942-53. Epub 2005 Aug 24.

ReferenceCitation: McGuire PK, Shah GM, Murray RM. Increased blood flow in Broca's area during auditory hallucinations in schizophrenia. Lancet. 1993 Sep 18;342(8873):703-6.

ReferenceCitation: McGurk SR, Twamley EW, Sitzer DI, McHugo GJ, Mueser KT. A meta-analysis of cognitive remediation in schizophrenia. Am J Psychiatry. 2007 Dec;164(12):1791-802.

ReferenceCitation: Montag C, Dziobek I, Richter IS, Neuhaus K, Lehmann A, Sylla R, Heekeren HR, Heinz A, Gallinat J. Different aspects of theory of mind in paranoid schizophrenia: evidence from a video-based assessment. Psychiatry Res. 2011 Apr 30;186(2-3):203-9. doi: 10.1016/j.psychres.2010.09.006. Epub 2010 Oct 14.

ReferenceCitation: Nakagami E, Hoe M, Brekke JS. The prospective relationships among intrinsic motivation, neurocognition, and psychosocial functioning in schizophrenia. Schizophr Bull. 2010 Sep;36(5):935-48. doi: 10.1093/schbul/sbq043. Epub 2010 May 12.

ReferenceCitation: Nasrallah H, Morosini P, Gagnon DD. Reliability, validity and ability to detect change of the Personal and Social Performance scale in patients with stable schizophrenia. Psychiatry Res. 2008 Nov 30;161(2):213-24. doi: 10.1016/j.psychres.2007.11.012. Epub 2008 Oct 11.

ReferenceCitation: Penn DL, Spaulding W, Reed D, Sullivan M. The relationship of social cognition to ward behavior in chronic schizophrenia. Schizophr Res. 1996 Jul 5;20(3):327-35.

ReferenceCitation: Penn DL, Corrigan PW, Bentall RP, Racenstein JM, Newman L. Social cognition in schizophrenia. Psychol Bull. 1997 Jan;121(1):114-32. Review.

ReferenceCitation: Penn D, Roberts DL, Munt ED, Silverstein E, Jones N, Sheitman B. A pilot study of social cognition and interaction training (SCIT) for schizophrenia. Schizophr Res. 2005 Dec 15;80(2-3):357-9. Epub 2005 Aug 31.

ReferenceCitation: Penn DL, Sanna LJ, Roberts DL. Social cognition in schizophrenia: an overview. Schizophr Bull. 2008 May;34(3):408-11. doi: 10.1093/schbul/sbn014. Epub 2008 Mar 28.

lead_sponsor: Hospital Center Alpes-Isère

location_facility:
Chs Le Valmont
Chs de La Savoie
CHU de CLERMONT-FERRAND
HCAlpesIsere
Chu Saint-Etienne
Ch Le Vinatier
Ch Annecy-Genevois
Ch Sainte-Marie


title: A Phase 1/2 Open-label, Multi-center, Safety, Preliminary Efficacy and Pharmacokinetic (PK) Study of Isatuximab in Combination With Other Anti-cancer Therapies in Participants With Lymphoma

summary:
Primary Objectives:

Phase 1

-To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory classic Hodgkin's lymphoma (cHL), diffuse large B-cell lymphoma (DLBCL) or peripheral T-cell lymphoma (PTCL), and to confirm the recommended Phase 2 dose (RP2D).

Phase 2

Cohort A1 (anti-programmed cell death protein 1/ligand 1 [PD-1/PD-L1] naïve cHL): To assess the complete remission (CR) rate of isatuximab in combination with cemiplimab.
Cohort A2 (cHL progressing from PD-1/PD-L1), B (DLBCL) and C (PTCL): To assess the objective response rate (ORR) of isatuximab in combination with cemiplimab.

Secondary Objectives:

To evaluate the safety of the RP2D of the combination of isatuximab with cemiplimab.
To evaluate the safety of the combination of isatuximab with cemiplimab and radiotherapy in patients with cHL.
To evaluate the immunogenicity of isatuximab and cemiplimab when given in combination.
To characterize the pharmacokinetic (PK) profile of isatuximab and cemiplimab when given in combination.
To assess overall efficacy of isatuximab in combination with cemiplimab and isatuximab in combination with cemiplimab and radiotherapy.

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_country:
Taiwan
Portugal
Spain
Italy
Korea, Republic of
France
Netherlands

location_facility:
Investigational Site Number :3800006
Investigational Site Number :5280001
Investigational Site Number :2500005
Investigational Site Number :2500006
Investigational Site Number :7240003
Investigational Site Number :3800003
Investigational Site Number :2500003
Investigational Site Number :7240005
Investigational Site Number :7240002
Investigational Site Number :1580002
Investigational Site Number :2500008
Investigational Site Number :2500002
Investigational Site Number :6200003
Investigational Site Number :3800002
Investigational Site Number :4100002
Investigational Site Number :6200002
Investigational Site Number :2500004
Investigational Site Number :4100001
Investigational Site Number :7240004
Investigational Site Number :2500001
Investigational Site Number :6200004
Investigational Site Number :2500007
Investigational Site Number :5280002


title: Dexamethasone Plus Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Patients With First Relapsed or Refractory Acute Myeloid Leukemia: a Randomized, Controlled, Open-label, Multicenter, Phase III Study

summary:
Recent preclinical and retrospective clinical data have suggested that dexamethasone might sensitize leukemic cells to chemotherapy-induced cell death and thus limit the risk of leukemic regrowth and relapse. Moreover, it has been experimentally shown that leukemic cells in acute myeloid leukemia patients who relapse become sensitive to glucocorticoids treatment highlighting a novel potential role for dexamethasone in relapsed or refractory acute myeloid leukemia (R/R).

This study was designed to determine whether adding dexamethasone to standard salvage therapy in the treatment of relapsed/refractory acute myeloid leukemia in adult patients (intensive chemotherapy amsacrine-cytarabine or azacitidine according to investigator's willingness) results in a significant improvement of the overall survival.

lead_sponsor: University Hospital, Toulouse

location_facility:
Institut Paoli Calmettes
CHU de Nantes
CHU de Grenoble
CHU de Poitiers
CHU de Nîmes
CHU de Bordeaux
CHU de Limoges
CHU de Montpellier


title: Study on the Occurrence of Head and Neck Cancers During Pregnancy

acronym: REFCORbirth

summary: Head and neck cancers that occurred during pregnancy

location_facility:
Chu Besancon
Chu Poitiers
Chu Bordeaux
Ap-Hp Tenon
Institut Gustave Roussy IGR
Chu Grenoble Alpes
Chu Toulouse
Centre François Baclesse


title: PilBouTox® Project: Prospective and Descriptive Study About Button Battery Poisoning Performed on Data Collected by French Poison Control Centres (PCC)

acronym: PILBOUTOX

summary: Button batteries are found in all householders and can be responsible for poisoning, in particular in children. Unexpected complications and death in children who have ingested button battery have been published for over twenty years in medical literature. There are many questions related to the treatment that remain unanswered, because some data are missing in previously published studies. The main objective of this study is to precisely describe poisoning cases by button battery in order to propose a better management

ReferenceCitation: Labadie M, Vaucel JA, Courtois A, Nisse P, Legeay M, Medernach C, Patat AM, Von Fabeck K, Gallart JC; French PCC Research Group, Tournoud C, Puskarczyk E. Button Battery Ingestion in Children (PilBouTox®): A Prospective Study Describing the Clinical Course and Identifying Factors Related to Esophageal Impaction or Severe Cases. Dysphagia. 2022 Jul 16. doi: 10.1007/s00455-022-10485-7. [Epub ahead of print]

lead_sponsor: University Hospital, Bordeaux


title: DEPREDICT: Clinical and Neurobiological Profile Predictive of Pejorative Outcome of Depression

acronym: DEPREDICT

summary:
Depression is a frequent disease which can be marked by therapeutic resistance. It is described as one of the most disabling disease with high cost for society. World Health Organization pointed out that 350 million people are suffering from depression in the world. This pathology is considered underdiagnosed, with inadequate care resources and stigmatization.

There is a wide range of evidence in current literature that anxiety is one of the most important factors involved in biological mechanism of treatment resistance in depression. To date, there is a lack of knowledge on this topic. A better understanding of the role of anxiety in the maintenance of depressive state will allow to i) identify quickly and more accurately patients at risk of pejorative evolution and ii) develop specific therapeutics targeting this dimension which remain badly controlled with actual therapeutics.

lead_sponsor: Rennes University Hospital

location_facility: CHU de Tours, Clinique Psychiatrique Universitaire


title: Optimization of Correcting Molecules of Nonsense Mutations in Epithelial Cells of the Upper Airways of Patients With Cystic Fibrosis With Nonsense Mutations in the CFTR Gene

summary:
The presence of a nonsense mutation leads to the rapid degradation of the carrier mRNA mutation by a mechanism called NMD (nonsense-mediated mRNA decay) [6, 13]. There are currently 3 main strategies at least for correcting nonsense mutations: exon skipping, inhibition of NMD and nonsense mutation readthrough.

In the laboratory, we developed a strategy for correcting nonsense mutations combining inhibition of NMD and activation of translecture. For this purpose, we have constructed screening systems to identify NMD-inhibiting and/or readthrough enhancers. The molecules thus identified are then tested on cell lines and in murine models carrying a nonsense mutation.

One of our goals is to select a set of molecules that can correct effectively nonsense mutations. For this we have to test these molecules on a great diversity of nonsense mutations.

This work will:

determine if we can correct all the nonsense mutations tested with at least one of our molecules
determine what is common within a group of mutations corrected by a given molecule
be able to assign the parameters that make one mutation is corrected by one molecule and not or little by another.

This study will therefore improve our theoretical knowledge on the recognition of premature stop codons but also to propose therapeutic approaches for the correction of nonsense mutations of the CFTR gene in cystic fibrosis in a targeted way for a patient.

lead_sponsor: University Hospital, Lille

location_facility: Hu Paris Centre Site Cochin Aphp - Paris 14


title: Medico Economic Study, Randomized, Comparing Intraoperative Radiotherapy With Intrabeam® on Surgical Resection Bed Versus Conventional Surgery + EBRT in Postmenopausal Patients Operated by Conservative Surgery for Low Risk Breast Cancer

acronym: RIOP-SEIN

summary:
Current breast cancer treatment is based on surgery, radiation, chemotherapy and hormonotherapy. Conservative surgery or mastectomy are followed by complementary externe radiotherapy.

This adjuvant external breast radiotherapy (EBRT) is heavy, spread over more than 6 weeks with :

25 sessions and delivery of a unit dose of 2 Gy to obtain a total dose of 50 Gy (5 sessions per week in general);
16 Gy overimpression (boost) dose located in the tumour bed, in 5 to 8 fractions, in situations at high risk of recurrence.

In addition, EBRT is responsible for many adverse effects, some of which can lead to lasting or permanent sequelae.

Many focused partial breast irradiation techniques have been developed in recent years with the objective of reducing the duration and morbidity of overall breast irradiation.

Among these techniques, intraoperative breast radiotherapy (IBRT) is recommended in cancers diagnosed at early stages for which tumorectomy is expected and which present a low risk of recurrence.

The main advantages of IBRTare :

Improvement of the quality of life due to a single session of radiotherapy associated with surgical ;
Increased precision to deliver the necessary dose in tumour tissue;
Preservation of surrounding healthy tissue ;
Reduction in the overall cost of treatment through shorter hospital stays and the absence of medical transport for conventional radiotherapy sessions.

RIOP SEIN is a project supported by Institut National du Cancer (INCa)

, which consists of a medico-economic evaluation of IBRT, with Intrabeam® system on surgical resection bed relative to conventional surgery + EBRT in postmenopausal patients operated by conservative surgery for Low risk breast cancer

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: INSTITUT REGIONAL DU CANCER MONTPELLIER - Val D'Aurelle