title: Randomized Phase II, 2-arm Study of Immunomodulation With Atezolizumab Concomitant With High Dose Radiation (SBRT) Versus SBRT Alone in Patients With Oligometastatic Sarcomas

acronym: Stereosarc

summary:
Up to 50% of soft tissue sarcoma (STS) patients will develop metastases in the course of their disease. Cytotoxic therapy is a standard treatment in this setting but yields average tumor response rates of 25% at first line and ≤10% at later lines. It is also limited in the number of lines and courses by tolerance issues. Trials include poly/oligometastases indistinctively and suggest that consolidation ablation is used in ~20% of patients with residual oligometastases refractory to chemotherapy. Oligometastases represent a stage of disease between completely absent and widely metastatic, and which might be cured if the limited numbers of metastatic sites are eradicated. Ablative strategies to treat patients with oligometastases from sarcomas yield prolonged survival times and stereotactic body radiation therapy (SBRT) is associated with excellent tolerance. Surgery may be offered in selected metastatic cases. Alternatively and increasingly, SBRT yields high control rates at treated sites (≥ 80%). The so-called radioresistance of sarcomas is overcome by the high doses per fraction made possible owing to the high precision achieved with SBRT. SBRT is an accepted treatment strategy provided that tumor burden remains limited in the number and size of metastases. Systemic treatment can be combined with SBRT. SBRT may produce abscopal effects where tumors outside the irradiation area also demonstrate tumor shrinkage in some occurrences. SBRT produces systemic antitumoral immune response in certain conditions and enhances radiation-induced tumor cell death compared to conventional lower dose irradiation. Abscopal effects have been potentialized with SBRT/immunotherapy in several tumor models. Sarcomas are a privileged target tumor given their high metastatic propensity.

Several potent immunomodulators that skew the tumor immune microenvironment toward a proimmunity context are being investigated in STS either alone or in combination with chemotherapy or targeted therapy. The PD-1 receptor is present within the tumor microenvironment, and limits the activity of infiltrating cytotoxic T lymphocytes, thus blocking effective immune responses. The action of PD-1 is triggered upon binding to its ligands. PD-1 can stimulate the immunosuppressive function of regulatory T cells. Moreover, blockade of PD-1 can stimulate anti-tumor immune responses. Significant responses have been obtained in several sarcomas with acceptable tolerance. Preliminary clinical experience suggests that immunotherapy can be efficient in refractory leiomyosarcomas. Several drugs targeting the PD-1/PD-L1/2 axis are ongoing either as single agents or in combination with ipilimumab, kinase inhibitors, or chemotherapy in STS subtypes. Combination of radiotherapy with immunotherapy is included as a means of increasing tumor antigen release in metastatic STS. Immunomodulated SBRT is a particularly attractive strategy, given the potential of radiation to induce cytotoxicity in tumors and induce abscopal effects. A phase II radiation trial showed increased apoptosis-, intra-tumoral dendritic cells and accumulation of intratumoral T cells in STS with correlation with tumor-specific immune responses.

We here propose a randomized phase II study to prolong progression-free survival (PFS) with the combination of SBRT/immunotherapy in oligometastatic STS patients.

SBRT is well-tolerated with hardly any severe toxicity (fewer than 5% acute and late grade 3 toxicities). It is performed in an ambulatory setting in only a few treatment fractions. Associations between irradiation and immunomodulatory agents appear to be synergistic and show favorable tolerance profiles. Immunomodulatory agents have a more favorable toxicity profile than cytotoxic agents with about 65% overall acute toxicities. Immunotherapy selectively binds to PD-L1 and competitively blocks its interaction with PD-1.

Compared with anti-PD-1 antibodies that target T-cells, immunotherapy targets tumor cells, and is therefore may induce fewer side effects, including a lower risk of autoimmune-related safety issues, as blockade of PD-L1 leaves the PD-L2 - PD-1 pathway intact to promote peripheral self-tolerance.

Stereotactic irradiation is associated with an excellent tolerance with rates of grade 3 or more toxicities below 5%.

Preliminary data of toxicity with the association of stereotactic irradiation and immunotherapy show no cumulative toxicity in association with immunotherapy. However, their incidence and characteristics are no different from that observed with stereotactic irradiation alone. Moreover, intracranial metastases are exceptional in sarcomas.

The toxicity of the association for extracranial stereotactic irradiation does not seem to be increased either.

ReferenceCitation: le Guevelou J, Debaigt C, Saada-Bouzid E, Viotti J, Khalladi N, Thibouw D, Penel N, Sunyach MP, Moureau-Zabotto L, Benchalal M, Veresezan O, Ducassou A, le Pechoux C, Jolnerovski M, Bazille C, Vaur D, Escande A, Serre R, Lovera C, Thariat J. Phase II study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas: STEREOSARC trial protocol. BMJ Open. 2020 Sep 23;10(9):e038391. doi: 10.1136/bmjopen-2020-038391.

family: le Guevelou

full_name: Jennifer le Guevelou

given: Jennifer

family: Debaigt

full_name: Colin Debaigt

given: Colin

family: Saada-Bouzid

full_name: Esma Saada-Bouzid

given: Esma

family: Viotti

full_name: Julien Viotti

given: Julien

family: Khalladi

full_name: Nazim Khalladi

given: Nazim

family: Thibouw

full_name: David Thibouw

given: David

family: Penel

full_name: Nicolas Penel

given: Nicolas

family: Sunyach

full_name: Marie Pierre Sunyach

given: Marie Pierre

family: Moureau-Zabotto

full_name: Laurence Moureau-Zabotto

given: Laurence

family: Benchalal

full_name: Mohamed Benchalal

given: Mohamed

family: Veresezan

full_name: Ovidiu Veresezan

given: Ovidiu

family: Ducassou

full_name: Anne Ducassou

given: Anne

family: le Pechoux

full_name: Cecile le Pechoux

given: Cecile

family: Jolnerovski

full_name: Maria Jolnerovski

given: Maria

family: Bazille

full_name: Celine Bazille

given: Celine

family: Vaur

full_name: Dominique Vaur

given: Dominique

family: Escande

full_name: Alexandre Escande

given: Alexandre

family: Serre

full_name: Raphael Serre

given: Raphael

family: Lovera

full_name: Christine Lovera

given: Christine

family: Thariat

full_name: Juliette Thariat

given: Juliette

location_facility:
Centre Eugene MARQUIS
Centre Georges François LECLERC
Centre Léon BERARD
Centre Antoine LACASSAGNE
Centre Henri BECQUEREL
Institut Claudius REGAUD
Institut de Cancérologie de Lorraine
Institut Gustave ROUSSY
Institut Paoli CALMETTES
Centre Oscar LAMBRET
Centre François BACLESSE


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.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: result

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.

family: Fabbri

full_name: Margherita Fabbri

given: Margherita

sequence: first

family: Leung

full_name: Clémence Leung

given: Clémence

sequence: additional

family: Baille

full_name: Guillaume Baille

given: Guillaume

family: Béreau

full_name: Matthieu Béreau

given: Matthieu

family: Brefel Courbon

full_name: Christine Brefel Courbon

family: Castelnovo

full_name: Giovanni Castelnovo

given: Giovanni

family: Carriere

full_name: Nicolas Carriere

family: Damier

full_name: Philippe Damier

given: Philippe

family: Defebvre

full_name: Luc Defebvre

given: Luc

family: Doe de Maindreville

full_name: Anne Doe de Maindreville

family: Fluchere

full_name: Frederique Fluchere

given: Frederique

family: Fuzzatti

full_name: Marie Fuzzatti

given: Marie

family: Grabli

full_name: David Grabli

family: Maltete

full_name: David Maltete

family: Rousseau

full_name: Vanessa Rousseau

given: Vanessa

family: Sommet A

full_name: Agnès Sommet A

given: Agnès

family: Thalamas

full_name: Claire Thalamas

given: Claire

family: Thiriez

full_name: Claire Thiriez

family: Rascol

full_name: Olivier Rascol

given: Olivier

family: Ory-Magne

full_name: Fabienne Ory-Magne

given: Fabienne

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Parkinsonism & Related Disorders

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

location_facility: Centre Hospitalier Universitaire de Nîmes - Caremeau

location_facility: Centre Hospitalier Universitaire de Marseille

location_facility: Centre Hospitalier Universitaire de Reims

location_facility: Centre Hospitalier Régionale Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Centre Hospitalier Universitaire de la Pitié-Salpêtrière


title: Effect of Opioid-free Anesthesia on Postoperative Opioid-related Adverse Events After Major or Intermediate Non-cardiac Surgery: a Multicenter Prospective Randomized Controlled Study

acronym: POFA

summary:
Since the 1960's, intraoperative administration of opioids is considered a keystone of anesthesia as well as hypnotics and muscle relaxants. Synthetic opioids were introduced to achieve hemodynamic stability during anesthesia. They allow an inhibition of the sympathetic system without cardiovascular collapse and histamine release. Since then, anesthesia has changed from inhalation to multimodal anesthesia with lower doses of hypnotic. In 2017, the intraoperative objectives of hypnosis, hemodynamic stability, immobility and anticipation of postoperative analgesia can be achieved without opioids. Moreover, opioid administration consequences are neither scarce nor benign for the patient. Perioperative opioids are associated with nausea and vomiting, sedation, ileus, confusion/delirium, respiratory depression, increased postoperative pain and morphine consumption, immunodepression, hyperalgesia and chronic postoperative pain. Among these complications, hypoxemia, ileus and confusion/delirium are the most frequent.

Efficacious multimodal analgesia and anesthesia are the basis of successful fast-track surgery. These multidrug regimens aim at decreasing postoperative pain, intra- and postoperative opioid requirements, and subsequently, opioid-related adverse effects and to fasten recovery. Opioid-free postoperative analgesia has been recommended for more than 10 years. Opioid-free anesthesia (OFA) is based on the idea that hemodynamic stability can be achieved without opioids during anesthesia. OFA is multimodal anesthesia associating hypnotics, N-methyl-D-aspartate (NMDA) antagonists, local anesthetics, anti-inflammatory drugs and alpha-2 agonists (Dexmedetomidine).

Proofs of the effect of OFA on reducing opioid-related adverse effects after major or intermediate non-cardiac surgery are still scarce. We hypothesized that the reduced opioid consumption during and after surgery allowed by OFA compared with standard of care will be associated with a reduction of postoperative opioid-related adverse events.

status: Terminated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Beloeil H, Laviolle B, Menard C, Paugam-Burtz C, Garot M, Asehnoune K, Minville V, Cuvillon P, Oger S, Nadaud J, Lecoeur S, Chanques G, Futier E; SFAR research network. POFA trial study protocol: a multicentre, double-blind, randomised, controlled clinical trial comparing opioid-free versus opioid anaesthesia on postoperative opioid-related adverse events after major or intermediate non-cardiac surgery. BMJ Open. 2018 Jun 30;8(6):e020873. doi: 10.1136/bmjopen-2017-020873.

apc_source: openAPC

family: Beloeil

full_name: Helene Beloeil

given: Helene

family: Laviolle

full_name: Bruno Laviolle

given: Bruno

family: Menard

full_name: Cedric Menard

given: Cedric

family: Paugam-Burtz

full_name: Catherine Paugam-Burtz

given: Catherine

family: Garot

full_name: Matthias Garot

given: Matthias

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Minville

full_name: Vincent Minville

given: Vincent

family: Cuvillon

full_name: Philippe Cuvillon

family: Oger

full_name: Sebastien Oger

given: Sebastien

family: Nadaud

full_name: Julien Nadaud

given: Julien

family: Lecoeur

full_name: Sylvain Lecoeur

given: Sylvain

family: Chanques

full_name: Gerald Chanques

given: Gerald

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Jean Moulin Lyon 3

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

location_facility:
Montpellier University Hospital
Perigueux Hospital
Clermont-Ferrand University Hospital
Rennes University Hospital
Saint-Brieuc Hospital
Metz-Thionville Hospital
Lille University Hospital
Beaujon Hospital
Nimes University Hospital
Nantes University Hospital
Toulouse University Hospital


type: Other Identifier

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.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre hospitalier universitaire de Grenoble Alpes

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Ongoing


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.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

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

intervention_type: Other


title: Combined Use of Contact Aspiration and the Stent Retriever Technique Versus Stent Retriever Alone for Recanalisation in Acute Cerebral Infarction: the Randomized ASTER2 Study

summary:
Mechanical thrombectomy (MT) with a stent retriever (SR) device is now the standard intervention in ischemic stroke with large vessel occlusion. Favorable outcome is strongly associated with the successful reperfusion status. New device of MT such as contact aspiration seems promising to increase reperfusion status and clinical outcome.

The main hypothesis is to show the superiority of combining the use of contact aspiration with a stent retriever compared to a stent retriever alone in treatment of acute stroke due to proximal arterial occlusion.

The primary endpoint is the rate of perfect reperfusion score at the end of the endovascular procedure.

primary_purpose: Other

ReferenceCitation: Lapergue B, Blanc R, Costalat V, Desal H, Saleme S, Spelle L, Marnat G, Shotar E, Eugene F, Mazighi M, Houdart E, Consoli A, Rodesch G, Bourcier R, Bracard S, Duhamel A, Ben Maacha M, Lopez D, Renaud N, Labreuche J, Gory B, Piotin M; ASTER2 Trial Investigators. Effect of Thrombectomy With Combined Contact Aspiration and Stent Retriever vs Stent Retriever Alone on Revascularization in Patients With Acute Ischemic Stroke and Large Vessel Occlusion: The ASTER2 Randomized Clinical Trial. JAMA. 2021 Sep 28;326(12):1158-1169. doi: 10.1001/jama.2021.13827.

name: Department of Neurology, Stroke Center, University of Versailles and Saint Quentin en Yvelines, Foch Hospital, Suresnes, France

family: Lapergue

full_name: Bertrand Lapergue

given: Bertrand

name: Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France

family: Blanc

full_name: Raphaël Blanc

given: Raphaël

name: Department of Neuroradiology, University Hospital Güi-de-Chauliac, Hospital Center University of Montpellier, Montpellier, France

family: Costalat

full_name: Vincent Costalat

name: Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nantes, Thorax Institute, INSERM 1087, CNRS, UNIV Nantes, Nantes, Pays de la Loire, France

family: Desal

full_name: Hubert Desal

given: Hubert

name: Department of Diagnostic and Interventional Neuroradiology, University Hospital of Limoges, Limoges, France

family: Saleme

full_name: Susanna Saleme

given: Susanna

name: Bicêtre Hospital, Department of Interventional Neuroradiology, Le Kremlin-Bicêtre, France

family: Spelle

full_name: Laurent Spelle

given: Laurent

name: Department of Diagnostic and Interventional Neuroradiology, University Hospital of Bordeaux, Bordeaux, France

family: Marnat

full_name: Gaultier Marnat

given: Gaultier

name: Department of Neuroradiology, Pitié-Salpêtrière Hospital, Paris, France

family: Shotar

full_name: Eimad Shotar

given: Eimad

name: Department of Diagnostic and Interventional Neuroradiology, University Hospital of Rennes, Rennes, France

family: Eugene

full_name: Francois Eugene

given: Francois

family: Mazighi

full_name: Mikael Mazighi

given: Mikael

name: Department of Neuroradiology, Lariboisière Hospital, Paris, France

family: Houdart

full_name: Emmanuel Houdart

name: Department of Diagnostic and Therapeutic Neuroradiology, University of Versailles and Saint Quentin en Yvelines, Foch Hospital, Suresnes, France

family: Consoli

full_name: Arturo Consoli

given: Arturo

family: Rodesch

full_name: Georges Rodesch

given: Georges

family: Bourcier

full_name: Romain Bourcier

given: Romain

name: University of Lorraine, CHRU-Nancy, Department of Diagnostic and Therapeutic Neuroradiology, F-54000 Nancy, France and University of Lorraine, IADI, INSERM U1254, F-54000 Nancy, France

family: Bracard

full_name: Serge Bracard

given: Serge

name: University of Lille, CHU Lille, ULR 2694 - METRICS: Assessment of Health Technologies and Medical Practices, F-59000 Lille, France

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Ben Maacha

full_name: Maalek Ben Maacha

given: Maalek

family: Lopez

full_name: Delphine Lopez

given: Delphine

family: Renaud

full_name: Nicholas Renaud

given: Nicholas

family: Labreuche

full_name: Julien Labreuche

family: Gory

full_name: Benjamin Gory

given: Benjamin

family: Piotin

full_name: Michel Piotin

given: Michel

location_facility:
CHU Rennes
CHU Limoges
Lariboisière (APHP)
Hôpital Foch
CHU Montpellier
CHU Bordeaux
Fondation Ophtalmologique Rotschild
CHU Nantes
La Pitié-Salpétrière (APHP)
CHU Nancy
Kremlin-Bicêtre (APHP)


title: A Retrospective Analysis of the Outcome of Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) Included in a Patient Named Program of Gemtuzumab Ozogamicin/Mylotarg®

acronym: MYLOR

summary:
Gemtuzumab Ozogamicin/Mylotarg® (GO) is a conjugate of a derivative of calicheamicin a potent antitumor anthracycline antibiotic linked to a recombinant humanized antibody against the CD33 antigen. Pivotal phase 2 study in relapsed AML adult patients used GO 9 mg/m2 as a monotherapy on days 1 and 14, and showed a 30% response rate with half CR and CRp (CR with incomplete platelets recovery). Four randomized studies, 3 in adults and 1 in children, performed in patients with non-previously treated AML tested the addition of lower doses of GO ( 3mg or 6 mg/m2) to standard induction chemotherapy and showed benefit on survival endpoints. Results from these studies were available in 2011 in adults and 2014 in children. In 2010 the french health agency (ANSM) opened a compassionate patient named program (authorization for temporary utilization (ATU) program) of GO in relapsed/refractory AML patients. Patients were orally informed about the status of the GO. From 2010 to 2012 it was recommended to use GO as a monotherapy at a dose of 9mg/m2 on days 1 and 14 according to the protocol used in pivotal phase 2 study. After 2012 it was recommended by the health authority to use GO at the dose of 3 or 6 mg/m2 in addition to chemotherapy regarding the toxicity of higher dose given once.

From 2010 to 2015 more than 500 AML patients have been included in this ATU program.

The main objective of the study presented here is to assess the efficacy and safety of GO 3 or 6 mg/m2 (single dose or fractionated GO) given in as treatment of relapsed/refractory AML in adult patients.

The coordinator choose to collect the data from centers that included 10 patients or more from January 2012 to December 2015.

This represents approximately 420 patients from 33 hematology departments.

status: Unknown status

time_perspective: Retrospective

lead_sponsor: Versailles Hospital

location_facility:
Hôpital Henri Mondor
Hôpital André Mignot
Hôpital Brabois Adultes
HIA Percy
Hôpital Hotel Dieu
Hopital Saint Louis
C.H. Lyon Sud
C.H.U. d'Angers
Hôpital de la Source
Hôpital du Bocage
C.H.U. d'Amiens - Hôpital Sud

intervention_type: Drug

status_simplified: Unknown


title: LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy for Stage III Colon Cancer Patients Treated in Adjuvant Setting: Impact on Oxaliplatin-induced Sensitive Neurotoxicity. A Multicenter Phase II Randomized Trial (LEANOX)

acronym: LEANOX

summary: Cytotoxic chemotherapy is usually scaled to the body surface area (BSA), and is currently not adjusted to the body proportions of lean and fat (i.e. body composition) of individual patients. Patients with low muscle mass behave like patients "overdosed" with chemotherapy resulted in dose-limiting toxicities (e.g. dose reductions, treatment delays or permanent treatment discontinuation), independently of the patient's weight.

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

location_facility: Institut regional du Cancer - Val d Aurelle

location_facility: Centre hospitalier régional et universitaire de Montpellier

lead_sponsor_type: industriel


title: A Multicentre Feasibility Randomized Study of Anti-PD-L1 Durvalumab (MEDI4736) With or Without Anti-CTLA-4 Tremelimumab in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma, Treated With a First-line Neo-adjuvant Strategy

acronym: INeOV

summary: This is a randomized, open, comparative, multi-centre study which will recruit up to 66 patients. The objective is mainly to explore the safety and feasibility in neo-adjuvant first-line ovarian cancer (including patients with primary peritoneal or fallopian tube adenocarcinoma) of various combinations of durvalumab with chemotherapy with or without tremelimumab.

status: Active, not recruiting

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility:
Hôpital Henri Duffaut
Centre Eugene Marquis
Groupe confluent
Centre Hospitalier Lyon Sud
Institut de Cancérologie de Lorraine
Hôpital Cochin
HEGP
ICM Val d'Aurelle
Institut Bergonié
Gustave Roussy
Institut René Godinot


title: Impact of a Systematic Palliative Care on Quality of Life, in Advanced Idiopathic Pulmonary Fibrosis (IPF). A Randomized Multi-center Trial.

acronym: PALIF

summary:
Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a survival median between 2 and 4 years which leads to a profound alteration of the quality of life.

In thoracic oncology, the systematic and early intervention of a palliative care team result in an improvement of quality of life for patients.

In the princeps study published in 2010, the early intervention of a dedicated palliative care team was compared to standard care in a randomized trial of 150 patients and shows a significant improvement : (i) of quality of life (main objective), (ii) of depression scores and even overall survival (11.6 months vs. 8.9 months, P = 0.02), (iii) a benefit in terms of understanding the diagnosis and therapeutic goals (3), (iv) diminution of adapted hospitalization in end of life (in emergency or not).

Considering some analogy points between IPF and advanced lung cancer (prognosis, respiratory symptom, psychological burden), it seemed reasonable to assume that the joint systematic intervention of chest physician and palliative care team may provide a significant benefit in terms of quality of life for patients with severe IPF.

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Swigris JJ, Brown KK, Behr J, du Bois RM, King TE, Raghu G, Wamboldt FS. The SF-36 and SGRQ: validity and first look at minimum important differences in IPF. Respir Med. 2010 Feb;104(2):296-304. doi: 10.1016/j.rmed.2009.09.006. Epub 2009 Oct 7.

ReferenceCitation: Swigris JJ, Kuschner WG, Jacobs SS, Wilson SR, Gould MK. Health-related quality of life in patients with idiopathic pulmonary fibrosis: a systematic review. Thorax. 2005 Jul;60(7):588-94. Review.

ReferenceCitation: Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.

family: Temel

full_name: Jennifer S. Temel

given: Jennifer S.

family: Greer

full_name: Joseph A. Greer

given: Joseph A.

family: Muzikansky

full_name: Alona Muzikansky

given: Alona

family: Gallagher

full_name: Emily R. Gallagher

given: Emily R.

family: Admane

full_name: Sonal Admane

given: Sonal

family: Jackson

full_name: Vicki A. Jackson

given: Vicki A.

family: Dahlin

full_name: Constance M. Dahlin

given: Constance M.

family: Blinderman

full_name: Craig D. Blinderman

given: Craig D.

family: Jacobsen

full_name: Juliet Jacobsen

given: Juliet

family: Pirl

full_name: William F. Pirl

given: William F.

family: Billings

full_name: J. Andrew Billings

given: J. Andrew

family: Lynch

full_name: Thomas J. Lynch

given: Thomas J.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Early Palliative Care for Patients with Metastatic Non–Small-Cell Lung Cancer

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hospitalier de Versailles Andre Mignot


ipd_sharing_description: no individual participant data is shared

lead_sponsor: UNICANCER

acronym: NISCAHN

location_facility:
Institut Curie Saint Cloud
Centre Antoine Lacassagne
Centre Léon Bérard
Centre Georges François Leclerc
Centre Paul Strauss
CHU Bordeaux
Institut Curie
ICM Val d'Aurelle
Centre René Gauducheau
Institut de cancérologie Alexis Vautrin
Gustave Roussy

type: EudraCT Number

source: euctr

title: A Phase II, Multicenter, Non Randomized, Open Label Study of Nivolumab In Recurrent and/or Metastatic Salivary Gland Carcinoma of the Head and Neck

summary:
INDICATION:

Patients with recurrent and/or metastatic salivary glands carcinoma who have progressed during the 6 months period before entering the study and who are eligible for nivolumab monotherapy.


title: Active Surveillance With or Without a 6 Months Apalutamide Treatment in Low Risk Prostate Cancer: A Phase II Randomized Multicenter Trial

acronym: PC-ARN

summary:
Many prostate cancer are slow or non progressive forms that would never impair quality or quantity of like of life if undetected. For this localized prostate cancer, the recommendation is an active surveillance, however often experienced by the patient as a lack of care. Thus the introduction of new potent androgen receptor inhibitor raise the question of the benefit of early hormonal therapy in localized prostate cancers.

The aim of this study is to assess whether treatment with an oral androgen receptor inhibitor could influence the progression of localized prostate cancer and delay the time to local treatment initiation.

lead_sponsor: Institut Paoli-Calmettes

location_facility:
CHRU Hopital Edouard Herriot
Clinique La Croix Du Sud
Chu Hotel Dieu
Clinique Beau Soleil
Chu Tenon
Chu Pontchaillou
Chu Saint Etienne
Institut Paoli Calmettes
Chu de Nice
Institut Mutualiste Montsouris
Hia Sainte Anne


title: Comparison of 3 Diagnostic Strategies of Pulmonary Embolism : Planar Ventilation-perfusion Scintigraphy (Planar V/Q Scan), Computed Tomography Pulmonary Angiography (CTPA), and V/Q Single Photon Emission Computed Tomography (SPECT)

acronym: SPECTACULAR

summary:
Pulmonary embolism (PE) remains a diagnostic challenge. False negative testing exposes patient to the risk of potentially fatal recurrence. False positive testing exposes patients to potentially fatal unduly side effects of anticoagulants.

Current diagnostic strategies rely on the sequential use of pretest clinical probability, Ddimer test, and chest imaging. Two chest imaging modalities have been validated for PE diagnostic exclusion: Computed Tomography Pulmonary Angiography (CTPA) and planar V/Q scan. Main limitations of planar V/Q are the high proportion of non-conclusive results, therefore requiring additional testing and more complex diagnostic algorithms. Main limitations of CTPA are its higher radiation dose and contraindications (renal failure).

In a randomized trial that compared strategies based on CTPA and on planar V/Q scan, a 30% increase in the rate of PE diagnoses was found in the arm using CTPA, raising the hypothesis of over-diagnosing and over-treating PE when using CTPA.

V/Q Single Photon Emission CT (SPECT) is a new method of scintigraphic acquisition that has been reported to improve the diagnostic performances of the test, which could reduce the number of non-conclusive tests and allow simplified diagnostic algorithms.

The investigators hypothesize that a strategy based on V/Q SPECT could be an alternative to the two usual approaches responding rightly to the two mains issues and combining the advantages of CTPA (simplified diagnostic approach) and planar V/Q (no overdiagnosis, lower radiation exposure, no contraindication).

Although a recent survey showed that up to 70% of nuclear medicine centers perform SPECT rather than planar imaging for diagnosing PE, a diagnostic management outcome study, in which diagnostic decision would be made on the basis of a standardized algorithm based on the V/Q SPECT is lacking. Such a study needs to be conducted to ensure that the safety of diagnostic exclusion using a V/Q SPECT based strategy is non-inferior to that of previously validated strategies, and to verify that the use of V/Q SPECT does not lead to over-diagnosis.

lead_sponsor: University Hospital, Brest

location_country: France Switzerland

location_facility:
CH des Pays de Morlaix
CHU de Dijon
Hegp - Ap-Hp
Hôpital des Armées Clermont Tonnerre
CHU Clermont Ferrand
CHU la Réunion
Geneva University Hospital
CHRU de Brest
Hopital Saint Esprit
CHU de Saint Etienne
CH Toulon
CHU d'ANGERS

intervention_type: Device


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: 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.

family: Coquan

full_name: Elodie Coquan

given: Elodie

family: Brachet

full_name: Pierre-Emmanuel Brachet

given: Pierre-Emmanuel

family: Licaj

full_name: Idlir Licaj

given: Idlir

family: Leconte

full_name: Alexandra Leconte

given: Alexandra

family: Castera

full_name: Marie Castera

given: Marie

family: Lequesne

full_name: Justine Lequesne

given: Justine

family: Meriaux

full_name: Emeline Meriaux

given: Emeline

family: Bonnet

full_name: Isabelle Bonnet

given: Isabelle

family: Lelaidier

full_name: Anais Lelaidier

given: Anais

family: Clarisse

full_name: Bénédicte Clarisse

given: Bénédicte

family: Joly

full_name: Florence Joly

given: Florence

journal_name: BMC Cancer

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Francois Baclesse

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


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


title: Diagnostic Reasoning and Sense of Alarm at Dyspnoea and / or Chest Pain

acronym: RaisDiag

summary: Dyspnea and chest pain represent 1.5% of general practice consultations. They may be a sign of many diseases, potentially serious. The concept of Gut Feelings brings a sense of alarm and reinsurance. The sense of alarm reflects a sense of mistrust about the patient's clinical situation, in the absence of objective argument. The sense of reinsurance reflects a sense of confidence about the patient's situation, in the absence of objective argument. Gut Feelings plays a key role in the diagnostic reasoning in general practice. A questionnaire measuring the Gut Feelings was validated in French after a linguistic validation procedure.

ReferenceCitation: Barais M, Fossard E, Dany A, Montier T, Stolper E, Van Royen P. Accuracy of the general practitioner's sense of alarm when confronted with dyspnoea and/or chest pain: a prospective observational study. BMJ Open. 2020 Feb 18;10(2):e034348. doi: 10.1136/bmjopen-2019-034348.

family: Barais

full_name: Marie Barais

family: Fossard

full_name: Emilie Fossard

given: Emilie

family: Dany

full_name: Antoine Dany

given: Antoine

family: Montier

full_name: Tristan Montier

given: Tristan

family: Stolper

full_name: Erik Stolper

given: Erik

family: Van Royen

full_name: Paul Van Royen

given: Paul

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repositories:
PubMed Central
irua

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Accuracy of the general practitioner’s sense of alarm when confronted with dyspnoea and/or chest pain: a prospective observational study

location_facility:
LOSQUIN André
CAM Françoise
AUFFRET Jean François
BEURTON-COURAUD Lucas
LE DUFF Nicolas
LE GOFF Delphine
MAHE Gwénaëlle
ABALAIN-VOREUX Aurélie
SIMON Benjamin
POINOT Anne
BODIN Bénédicte


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.

family: Kerneis

full_name: Solen Kerneis

given: Solen

family: Visseaux

full_name: Benoit Visseaux

given: Benoit

family: Armand-Lefevre

full_name: Laurence Armand-Lefevre

given: Laurence

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

journal_name: Current Opinion in Infectious Diseases

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ipd_sharing: Undecided

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

location_facility: Hôpitaux Universitaires Paris Centre-Site Cochin

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

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

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

intervention_type: Diagnostic Test


type: Registry Identifier

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.

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

status_simplified: Completed


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


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

lead_sponsor: GlaxoSmithKline

primary_purpose: Prevention

location_country:
Italy
United Kingdom
France
Spain

ipd_sharing: Yes

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

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: STIM'ZO : Examining tDCS as an add-on Treatment for Persistent Symptoms in Schizophrenia (SCH)

acronym: STIM'ZO

summary:
This project aims to provide the proof of concept for transcranial direct-current stimulation (tDCS) in the treatment of resistant/persistent Schizophrenia symptoms. The purpose is to investigate the effect of tDCS on symptoms in schizophrenic patients demonstrating a partial response to a first frequently prescribed antipsychotic medication. An early optimization of the therapeutic strategy must constitute an important factor for prognosis. Hypothesize is that tDCS should alleviate symptoms in patients depending on the clinical characteristics. In this study, stimulation is an add-on treatment to antipsychotic medication, and will be used in a broad variety of patients, i.e. in patients with varied durations of illness, various symptoms profiles, and various levels of treatment response. This in turn will allow the determination of the extent to which results can be generalized to varied patient populations, as well as the extent to which various therapeutic targets (e.g. different symptom dimensions, cognitive performance and brain connectivity) may be improved with tDCS. Despite interesting preliminary results, our team is unable to describe optimal non-invasive brain stimulation (NIBS) response markers.

This study is a randomized, double blind, controlled, French multicenter study (11 centers). The investigators plan to include 138 patients with persistent symptoms in schizophrenia. Sixty-nine subjects will receive active tDCS and 69 subjects will receive sham tDCS (placebo). Hypothesize is a lasting effect of active tDCS on the schizophrenic symptoms as measured by the number of responders, defined as a decrease of at least 25% of symptoms as measured by a standardized clinical scale score (PANSS) between baseline and after the 10-session tDCS regimen.

Furthermore, the participants believe that an in depth understanding of the cortical effects of tDCS could constitute an important step towards improving the technique and developing treatment response markers. An analysis of the effects on cortical activity and plasticity markers could be an interesting approach.

location_country: Monaco France

location_facility: CHU de Clermont-Ferrand - Pôle de Psychiatrie B

location_facility: Centre Esquirol - CHU de Caen - Service de Psychiatrie Adulte,

location_facility: Hôpital Fontan - CHRU de Lille - Pôle de Psychiatrie

location_facility: Hôpital Civil - CHU Strasbourg - CEntre de neuro-Modulation Non-Invasive

location_facility: CHRU de Tours - Clinique Psychiatrique Universitaire

location_facility: Hôpital Edouard Herriot - Service d'Urgences Psychiatriques

location_facility: Centre Hospitalier Le Vinatier - Service de Psychiatrie Adulte

location_facility: Hôpital de la Colombière - CHU Montpellier - Service de Psychiatrie Adulte

location_facility: Centre Hospitalier Princesse Grace - Service de Psychiatrie

location_facility: Centre Hospitalier Saint-Antoine - Service de Psychiatrie

location_facility: Centre Hospitalier Saint-Anne - Service de Psychiatrie Adultes

location_facility: CHU de St-Etienne - Service d'Urgences Psychiatriques


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.

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: Hôpital Hautepierre - Department of HPB surgery and liver transplantation

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

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

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


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.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Hôpital d'Instruction des Armées de Bégin


lead_sponsor: Mundipharma SAS

acronym: Pen ASAP

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

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

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.

ReferenceCitation: Addington J, Addington D. Neurocognitive and social functioning in schizophrenia: a 2.5 year follow-up study. Schizophr Res. 2000 Jul 7;44(1):47-56.

ReferenceCitation: Addington J, Saeedi H, Addington D. Influence of social perception and social knowledge on cognitive and social functioning in early psychosis. Br J Psychiatry. 2006 Oct;189:373-8.

ReferenceCitation: Aleman A, Hijman R, de Haan EH, Kahn RS. Memory impairment in schizophrenia: a meta-analysis. Am J Psychiatry. 1999 Sep;156(9):1358-66.

ReferenceCitation: Baudouin JY, Martin F, Tiberghien G, Verlut I, Franck N. Selective attention to facial emotion and identity in schizophrenia. Neuropsychologia. 2002;40(5):503-11.

ReferenceCitation: Baron-Cohen S, Leslie AM, Frith U. Does the autistic child have a "theory of mind"? Cognition. 1985 Oct;21(1):37-46.

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

ReferenceCitation: Bentall RP, Corcoran R, Howard R, Blackwood N, Kinderman P. Persecutory delusions: a review and theoretical integration. Clin Psychol Rev. 2001 Nov;21(8):1143-92. Review.

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.

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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.

family: Livingston

full_name: James D. Livingston

given: James D.

family: Boyd

full_name: Jennifer E. Boyd

given: Jennifer E.

journal_name: Social Science & Medicine

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Correlates and consequences of internalized stigma for people living with mental illness: A systematic review and meta-analysis

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.

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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.

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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.

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


acronym: REFRACT

location_facility:
AP-HM
CH de Beauvais
Service de Pneumologie
CHU de Limoges
Institut Paoli-Calmettes
CH de Bretagne Sud
Instiut de Cancérologie
CHU Brest
Centre Hospitalier F. Quesnay

title: Multicenter Phase II Trial of Nintedanib (Vargatef®) Plus Docetaxel in Second Line of Treatment in Patients With no Squamous Non Small Cell Lung Cancer Refractory to First Line Chemotherapy

summary: The purpose of this study is to determine whether nintedanib (vargatef®) combined with docetaxel are effective in second line of treatment in patients with no squamous non small cell lung cancer refractory to first line chemotherapy.


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


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


title: Non-randomised Open Label Pilot Study of Sirolimus Therapy for Segmental Overgrowth Due to PIK3CA- Related Overgrowth

acronym: PROMISE

summary:
It was found that people who have an excessive growth in one or more parts of their body and normal growth in other parts, may have a change in genes responsible for controlling cell growth. This genetic discovery identified a possible treatment for this overgrowth, called Sirolimus.

This is a pilot study, which help the investigators prepare a larger international study, which will aim to determine whether a treatment based Sirolimus is able to stop the excessive growth of one or more parties of their body in people who carry a genetic change in the PIK3CA gene (phosphatidylinosilol-3-kinase encoded by the gene PIK3CA).

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Pôle Cardiovasculaire et Métabolique - Hôpital Larrey

location_facility: CHRU de Montpellier - Hôpital Saint-Eloi


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: Multicenter Validation of the Sensitivity of Theranostic ALK Rearrangement Detection by FISH Analysis and Prevalence of Escaping Mutations in Circulating Tumor Cells for the Non-invasive Management of Lung Cancer Patients

summary:
Patients eligibility to targeted therapies relies on a molecular test performed on a tumor sample collected by biopsy. This invasive procedure is associated with a relative high risk of morbidity and requires the intervention of a costly and important technical platform. Thus, inoperable patients can be deprived from potentially more efficient therapies. A "liquid biopsy" of Circulating Tumor Cells (CTCs) present in the blood and their molecular characterization is an appealing alternative to meet an urgent need for these patients. Moreover no CTC-based molecular test is currently routinely available.

The 5-year survival rate of patients with non-small cell lung carcinoma (NSCLC) is low. Recent reports demonstrated that the detection of an ALK rearrangement in the tumor tissue allows patients with late-stages NSCLC to benefit from crizotinib treatment.

However, 1) the detection of an ALK rearrangement is currently performed on small biopsies or fine-needle aspirates and can be hindered by the limited tissue quantities available. Tumor tissue is difficult to obtain in patients with advanced/metastatic lung cancer for whom surgery is rarely a component of treatment. Finding alternative and more effective means of diagnosing an ALK rearrangement are critical issues for identifying patients who may benefit from treatment with crizotinib; 2) some patients develop resistance to crizotinib due to de novo ALK mutations.

In this setting, circulating tumor cells (CTCs), which have been shown to be detectable by ISET (Isolation by Size of Epithelial Tumor Cells) method in 80% to 100 % of late stages lung cancer patients represent a non-invasive and easily accessible source of tumor material for assessing ALK rearrangement and escaping mutations in a kinetic manner. The ISET method was first published in 2000 and several independent teams have now established its high sensitivity and specificity of ISET for NSCLC. With ISET, specificity can be achieved using the same methods and criteria used by cytopathologists to diagnose solid tumors.

The high sensitivity and specificity of ISET are two essential starting points for the feasibility of this present project. Low-throughput molecular characterization of CTCs isolated by ISET has also been achieved. The remaining challenge consists in developing high-throughput ISET-based molecular tests for personalized medicine that are transferable to the clinics.

The Team 1 at the CHU de Nice and the Team 2 at the Gustave Roussy Institute have demonstrated that the detection of an ALK rearrangement in CTC isolated by ISET is feasible and consistent with results obtained in corresponding tumor tissues. In this context, the aim of this project is to obtain 1) a definitive prospective clinical validation of the use of CTC as an alternative to tumor tissue for ALK analysis-based patients stratification; 2) a proof that escaping mutations can be detected early by kinetic analysis of CTC in patients treated by crizotinib. ALK rearrangement will be prospectively investigated in CTCs isolated by ISET at diagnosis and during follow up from patients with stage IIIb/IV lung cancer and de novo mutations will be searched in patients with resistance to crizotinib. This study will provide both clinical and economic benefit to targeted treatment of patients with advanced lung cancer.

This project is strongly original as no CTC-based ALK rearrangement test has been independently validated up to now with clinical samples. The development of non-invasive theranostic test through the genetic analysis of CTCs is a clinically relevant goal for non-invasive stratification of cancer patients, avoiding morbidity related to lung biopsy and surgery. It would allow determining patient's eligibility to targeted therapies on a blood sample analysis. CTC-based ALK test could be useful to guide the choice of ALK targeted therapy in patients with lung cancer. Furthermore, developing biomarkers based on CTCs analysis would open the way to the non-invasive follow up of aggressive cancers, early detection of mutations associated with resistance to targeted therapies and tailoring treatment to a real time analysis of the evolving tumor cell populations. This test is expected to markedly improve patients' quality of life avoiding invasive diagnostic procedures.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Centre Antoine Lacassagne
Centre François Baclesse
Hôpital Tenon
CHU de Nice
Institut de Cancérologie de Lorraine
Marseille University Hospital
Institut arnault tzanck
Nancy university hospital
Grenoble university hospital
Institut Gustave Roussy
Toulouse University Hospital


title: Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm.

summary:
This is a prospective, non-randomized and multicenter study designed to compare biological features between pN0 triple negative breast cancer (TNBC) with size ≤ 10 mm (pT1a/b) versus pT1c T2 ≤ 30 mm.

All consecutive patients will be recruited by each investigator after completion of surgery. No modification of standard management according to each investigator center will be done. All patients will then be followed each year during 5 years in order to collect the following events: local and loco regional recurrence, metastatasis, second cancer, death or not and the cause.

At initial visit, a 10 mL blood sample will be collected (= study intervention) and immediately processed for serum storage; all serum samples will be stored at -80°C and may be used for the purpose of further scientific research.

A representative formalin-fixed paraffin-embedded tumor block of all 200 samples will be addressed at the Institut Claudius Regaud for central collection which will consist of one haematoxylin-eosin stained slide for central histological review, up to 15 unstained slides for DNA extraction (after microdissection), and construction of a tissue micro-array (TMA).

Extracted DNA from 100 samples (50 in each group) will then be transferred to Institut Paoli Calmettes, Marseille; extracted DNA will be subjected to array-CGH analysis in order to detect gene copy number alterations such as gains/amplifications/deletions, and to next generation sequencing (NGS; MiSeq, Illumina) using a panel of ~400 genes for mutation detection.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut de Cancerologie de L'Ouest - Site Paul Papin

location_facility: Institut de Cancerologie de L'Ouest - Site Rene Gauducheau

intervention_type: Procedure


title: A Phase 2 Study of XL184 (Cabozantinib) in Treating Patients With Relapsed Osteosarcomas and Ewing Sarcomas

summary: This phase II trial studies how well cabozantinib s-malate works in treating patients with osteosarcoma or Ewing sarcoma that has grown or returned (come back) after a period of improvement. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may also prevent the growth of new blood vessels that tumors need to grow.

ReferenceCitation: Italiano A, Mir O, Mathoulin-Pelissier S, Penel N, Piperno-Neumann S, Bompas E, Chevreau C, Duffaud F, Entz-Werlé N, Saada E, Ray-Coquard I, Lervat C, Gaspar N, Marec-Berard P, Pacquement H, Wright J, Toulmonde M, Bessede A, Crombe A, Kind M, Bellera C, Blay JY. Cabozantinib in patients with advanced Ewing sarcoma or osteosarcoma (CABONE): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Mar;21(3):446-455. doi: 10.1016/S1470-2045(19)30825-3. Epub 2020 Feb 17.

family: Italiano

full_name: Antoine Italiano

family: Mir

full_name: Olivier Mir

given: Olivier

family: Mathoulin-Pelissier

full_name: Simone Mathoulin-Pelissier

given: Simone

family: Penel

full_name: Nicolas Penel

given: Nicolas

family: Piperno-Neumann

full_name: Sophie Piperno-Neumann

given: Sophie

family: Bompas

full_name: Emmanuelle Bompas

given: Emmanuelle

family: Chevreau

full_name: Christine Chevreau

given: Christine

family: Duffaud

full_name: Florence Duffaud

family: Entz-Werlé

full_name: Natacha Entz-Werlé

given: Natacha

family: Saada

full_name: Esma Saada

given: Esma

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

family: Lervat

full_name: Cyril Lervat

given: Cyril

family: Gaspar

full_name: Nathalie Gaspar

given: Nathalie

family: Marec-Berard

full_name: Perrine Marec-Berard

given: Perrine

family: Pacquement

full_name: Hélène Pacquement

given: Hélène

family: Wright

full_name: John Wright

given: John

family: Toulmonde

full_name: Maud Toulmonde

given: Maud

family: Bessede

full_name: Alban Bessede

given: Alban

family: Crombe

full_name: Amandine Crombe

given: Amandine

family: Kind

full_name: Michèle Kind

given: Michèle

family: Bellera

full_name: Carine Bellera

given: Carine

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.

name:
Laboratory of Experimental Oncology, Pharmacogenomics and Pharmacogenetics Research Unit, IRCCS Istituto Ortopedico Rizzoli,
      Bologna, Italy

location_facility: Institut de Cancerologie de l'Ouest-Rene Gauducheau


type: Other Grant/Funding Number

title: Evaluation of Treatment by Transcutaneous Electrical Nerve Stimulation (TENS) of the Posterior Tibial Nerve for Lower Urinary Tract Disorders in Parkinson's Syndrome

acronym: UROPARKTENS

summary:
Only one study has evaluated the effect of TENS in LUTD in Parkinson's syndromes. It was reported at the congress of the "Société Interdisciplinaire Francophone d'UroDynamique et de Pelvi-Perinéologie" (SIFUD-PP) in 2011 by Ohanessian et al., and comprised 6 female patients with Parkinson's disease (PD) or multisystem atrophy (MSA), with overactive bladder. Transcutaneous electrical nerve stimulation, 20 minutes daily for 6 weeks, was associated with subjective improvement of LUTD assessed with the Patient Global Impression of Improvement (PGI-I) in 5 of the 6 patients.

In view of the encouraging results of this pilot study, we hypothesize that TENS treatment may improve LUTD in patients with a Parkinson's syndrome, Parkinson's disease (PD) and multisystem atrophy (MSA).

ReferenceCitation: Castel-Lacanal E, Gamé X, Clanet M, Gasq D, De Boissezon X, Guillotreau J, Bourg V, Viala F, Rischmann P, Marque P. Urinary complications and risk factors in symptomatic multiple sclerosis patients. Study of a cohort of 328 patients. Neurourol Urodyn. 2015 Jan;34(1):32-6. doi: 10.1002/nau.22495. Epub 2013 Sep 23.

location_facility:
UHToulouse
Hospital Chenevier
University hospital
University Hospital
Uiversity hospital
Hospital Dubos
Pontchaillou Hospital
Clinique Saint Augustin
Hospital Poincare
Huriez Hospital


title: Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint

acronym: D-COG

summary: As recommended allowance of oral vitamine D are unable to ensure the recommended serum concentration of vitamine D, the purpose of this study is to show that a dose of vitamin D3 higher than the recommended allowance may slow the cognitive decline of patients with a memory complaint.

lead_sponsor: University Hospital, Tours

location_facility: CHU BREST - Hôpital de la Cavale Blanche


acronym: ADEQUATEartère

location_facility:
CHU de Caen
CHU de Angers
CHU de Strasbourg
CHU de Amiens
CHU de Clermont-Ferrand
HEGP
CHRU de Tours
Necker
CHU de Rennes
CHU de Rouen
CHU de Toulouse

title: Effect of Advagraf on Arterial Stiffness and on Vascular Fibrosis Plasma Markers on de Novo Renal Transplant Patients

summary: The purpose of this study is to compare parallel-group effects between 4 months and 12 months post-transplantation 2 values of target residual concentrations of Advagraf on vascular parameters in de novo renal transplant patients.


title: Pulmonary Rehabilitation in Fibrotic Pulmonary Sarcoidosis (Stage IV): Randomized Controlled Trial

summary:
The primary objective of the study is to assess the improvement of daily activity in subjects with Stage IV Pulmonary Sarcoidosis one year after the conduct of a pulmonary rehabilitation program.

The secondary objectives are the following:

assess the improvement of daily activity at several times : 2, 6 and 12 months after the beginning of a pulmonary rehabilitation program
assess the improvement of exercise capacity by tests used in medical practice
assess the correlation between daily activity and exercise capacity
assess the improvement of dyspnea
assess the improvement of quality of life and psychological state

ReferenceCitation: Wallaert B, Kyheng M, Labreuche J, Stelianides S, Wemeau L, Grosbois JM. Long-term effects of pulmonary rehabilitation on daily life physical activity of patients with stage IV sarcoidosis: A randomized controlled trial. Respir Med Res. 2020 Mar;77:1-7. doi: 10.1016/j.resmer.2019.10.003. Epub 2019 Oct 28.

family: Wallaert

full_name: B. Wallaert

given: B.

family: Kyheng

full_name: M. Kyheng

given: M.

family: Labreuche

full_name: J. Labreuche

given: J.

family: Stelianides

full_name: S. Stelianides

given: S.

family: Wemeau

full_name: L. Wemeau

given: L.

family: Grosbois

full_name: J.M. Grosbois

journal_name: Respiratory Medicine and Research

lead_sponsor: University Hospital, Lille

location_facility: Service de Pneumologie, Hôpital Victor Provo

location_facility: Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP

location_facility: Clinique des Voies Respiratoires, Hôpital Larrey

location_facility: Service de pneumologie, Hôpital Avicenne AP-HP

location_facility: Clinique des Maladies Respiratoires, CHRU de LILLE

location_facility: Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice


title: Randomized Trial Comparing Functional Digestive Outcomes Related to Two Types of Management of Rectal Endometriosis: Continuous Hormonal Treatment and Curative Surgery

acronym: MESURE

summary:
The purpose of this study is to determine whether, in women with deep endometriosis involving the rectum and not intending to get pregnant, continuous hormonal treatment would be followed by better digestive functional outcomes than curative rectal surgery. Are included women from 35 to 50 years presenting with deep endometriosis infiltrating at least the muscular layer of the rectum and not having pregnancy intention.

The main outcome concerns the quality of digestive function 24 after the onset of the treatment, assessed using a composite variable: patient considering that digestive function is normal AND the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score) <7 AND the Gastrointestinal Quality of Life Index (GIQLI) score >100.

Secondary outcomes are: presence of severe constipation, increased frequency of daily bowel movements, anal incontinence, postoperative dysuria, Biberoglou & Behrman score, quality of life SF36 score, KESS score, GIQLI, Wexner score of anal continence, Bristol stools score, the rate of postoperative complications, medical treatment adverse outcomes, the rate of additional endoscopic and surgical procedures.

The randomization is central, once the physician asses the diagnosis, explain the study's principle and rece In the arm A, the patients received triptoreline and add back therapy by estradiol during 6 months, followed by daily intake of cyproterone acetate and add back therapy during 18 months.

In the arm B, patients are managed by rectal surgery (depending on the surgeon choice: rectal shaving, rectal disc excision or colorectal resection) followed by the prevention of recurrences by daily intake of cyproterone acetate and add back therapy during 18 months.

The number of subjects required is 78 (39 on each arm). Inclusions period is estimated at 24 months. The length of the follow up is 24 months. The patients have 8 visits in the arm A, and 7 visits in the arm B.

Eleven French tertiary referral centres will enrol patients in the trial.

lead_sponsor: University Hospital, Rouen

location_facility: Service de Gynécologie, Obstétrique et Médecine de la Reproduction CHU de CLERMONT-FERRAND Hôpital ESTAING 1 place Lucie Aubrac

location_facility: Service de Gynécologie-Obstétrique CHU de NIMES

location_facility: Service de Gynécologie-Obstétrique AP-HP Hôpital du KREMLIN BICETRE


acronym: COMARIS

location_facility: Médecine polyvalente, CH de SAINT NAZAIRE

title: Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)

summary: The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.


title: Clinical Benefits and Tolerance to a New Ventilatory Mode in Patients With Obesity Hypoventilation Syndrome (OHS).

summary: In 2012, it has announced the availability of the new ventilator (BiPAP- A40), which could offer potential advantages over fixed level pressure support, in particular, in patients with obesity hypoventilation syndrome (OHS). One of the key benefits of the BiPAP A40 is an innovative ventilation mode called AVAPS-AE, which automatically maintains airway patency while delivering the correct level of ventilation each user requires, whatever their body position or sleep stage. AVAPS-AE mode is also aimed to help the clinicians during the initial titration of therapy, while providing long term comfort and assuring therapy compliance. However, studies on the physiologic and clinical effects have not yet been performed. The aim of our singled-blind randomised multicentre controlled trial is to prospectively investigate the effects of BiPAP with the spontaneous/timed (S/T) or the AVAPS-AE ventilation mode over 8 weeks on sleep quality, ventilation pattern, gas exchange, symptoms, body composition, level of physical activity and health-related quality of life in OHS patients.

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

location_facility: Centre Hospitalier Universitaire d'Angers


title: Optimization of Health Expenditure in Major Surgery: Impact of a Mixed, Clinical and Ethnographic Approach in the Model of Liver Surgery

summary: The aim of this study is to reduce the length of stay after liver surgery by taking account of objective quantitative clinical variables, subjective qualitative clinical variables and non clinical variables.

ReferenceCitation: Cauchy F, Farges O, Vibert E, Boleslawski E, Pruvot FR, Regimbeau JM, Mabrut JY, Scatton O, Adham M, Laurent C, Grégoire E, Delpero JR, Bachellier P, Soubrane O. Sensitizing Surgeons to Their Outcome Has No Measurable Short-term Benefit. Ann Surg. 2017 Nov;266(5):884-889. doi: 10.1097/SLA.0000000000002403.

family: Cauchy

full_name: Francois Cauchy

given: Francois

family: Farges

full_name: Olivier Farges

given: Olivier

family: Vibert

full_name: Eric Vibert

given: Eric

family: Boleslawski

full_name: Emmanuel Boleslawski

given: Emmanuel

family: Pruvot

full_name: Francois René Pruvot

given: Francois René

family: Regimbeau

full_name: Jean Marc Regimbeau

given: Jean Marc

family: Mabrut

full_name: Jean Yves Mabrut

given: Jean Yves

family: Scatton

full_name: Olivier Scatton

family: Adham

full_name: Mustapha Adham

given: Mustapha

family: Laurent

full_name: Christophe Laurent

given: Christophe

family: Grégoire

full_name: Emilie Grégoire

given: Emilie

family: Delpero

full_name: Jean Robert Delpero

given: Jean Robert

family: Bachellier

full_name: Philippe Bachellier

given: Philippe

family: Soubrane

full_name: Olivier Soubrane

journal_name: Annals of Surgery

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
Paoli calmette institute
Bordeaux Hospital
Beaujon University Hospital
Strasbourg hospital
Marseille Hospital
Gustave Roussy institute
Paul Brousse Hospital
Amiens North Hospital
Saint Antoine Hospital
Lille Regional Hospital
Lyon Hospital