title: Intubation of Obese Patients in the Operating Room With or Without Bag-Mask Ventilation. A Randomized Multicentre Study

acronym: VENT OR NOT

summary: The aim of the study is to answer a daily question in the operating room: what is the safest technique for intubation of severe/morbid obese patients (BMI 35 or more). There is a great heterogeneity of practices on the subject, so the principle is to determine a common practice to facilitate the management of these patients.

location_facility:
CHRU Brest
CHU Nantes
CHU de Nantes - site Laennec
HCL - Hôpital Edouard Herriot
CHU Toulouse
CH de Valenciennes
CHU Poitiers
CHRU Tours
CHU Angers


type: Other Identifier

title: Assessment of Participant Adherence and Glucose Control While Using a Connected Insulin Management Platform

summary: The main purpose of this study is to assess participant adherence and glucose control while using a connected insulin management platform. Approximately 50 participants will be enrolled in each country.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Eli Lilly and Company

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

location_facility: Groupe Hospitalier Mutualiste Les Portes du Sud

location_facility: Centre Hospitalier Sud Francilien-Pharmacie

location_facility: CHU - l'Assistance Publique - Hôpitaux de Marseille

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock: a Multicenter, Randomized Controled Trial.

acronym: VICEPAC

summary:
Among patients admitted after an out-of-hospital cardiac arrest (OHCA) in intensive care unit (ICU), almost two thirds of patients will develop in the first hours a post-cardiac arrest (CA) shock. This post-CA shock, combines cardiac and hemodynamic failure, generally resulting in multi-organ failure and early death in up to 35% of patients. Experimental data suggest that intravenous ascorbic acid (vitamin C) may attenuate inflammation and vascular injury related to sepsis or surgery. Preclinical and clinical studies also provide safety data of high dose intravenous vitamin C (> 200mg/kg/day) with no significant adverse event reported and favorable impact on outcome. Experimental data also suggest beneficial effect of vitamin C in post-CA management with improvement of shock and multi-organ failure with potential benefit on neuroprotection and outcome.

The study is a phase II multicenter prospective controlled open-label trial randomized in two parallel groups :

Expérimental group: Standard of care care for post-CA shock + Vitamin C (Vit-C) 200mg/kg/d IV (started as early as possible, no later than 1 h after randomization + thiamin (Vit B1) 200mg every 12 h during 3 days.
Control group: Standard of care care for post CA shock according international guidelines.

Patient number to be enrolled : 234, Study duration :24 months and 28 days, Inclusion duration : 24 months, Patient participation : duration : 28 days

study_start_date_type: Anticipated

status: Not yet recruiting

design_allocation: Randomized

lead_sponsor: Centre Hospitalier de Bethune

collaborators: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Universitaire de LILLE

location_facility: Centre Hospitalier Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Universitaire d'Amiens

lead_sponsor_type: academique


title: Doubled Blind Evaluation of the Efficacy of High Intensity Focused Ultrasound (HIFU) Treatment on Symptoms in Patients Treated for Rectal Endometriosis Compared to Sham.

summary:
Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative procedure using a high-intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation.

Focal One® is a transrectal HIFU device, which is validated to treat prostatic cancer.

In this comparative, randomized, double blind study , the primary objective is to evaluate the efficacy of the HIFU treatment of rectal endometriosis with Focal One® HIFU device on the Acute Pelvic Pain 3 months after HIFU treatment, in comparison to a Sham group.

lead_sponsor: EDAP TMS S.A.

location_facility:
Chu Estaing
Hopital Privé de Provence
Hopital de la Croix Rousse
Hôpital privé Le Bois
CHU de Angers
Clinique Tivoli-Ducos
Hôpital COCHIN
Hôpital du Kremlin Bicetre
CHU Strasbourg

intervention_type: Device


title: Effect of a Personalized Weaning Strategy on Weaning Success

acronym: P-Wean

summary:
Weaning from mechanical ventilation is a daily challenge in intensive care units, as it can take up to 50% of the total duration of ventilation. The longer the duration of ventilation is, the more there is complication related with it.

Even when the spontaneous breathing trial is succeeded, 10 to 20% of extubations are failed and requires re-intubation.

There is two different ways to assess if the patient is capable of breathing by its own : T-piece which can be considered as hard to succeed (it can delay extubation for some patients) or pressure support ventilation with no PEEP which can be too easy and lead to an extubation too early.

Studies have identified risk factors of weaning induced pulmonary oedema wich is one of the main cause of failed extubation (up to 60%).

The purpose of P-WEAN is to evaluate whether a personalized strategy for weaning from mechanical ventilation, including daily search for weaning criteria and individualization of the weaning modality (T-piece or pressure support ventilation with zero PEEP) based on the existence of WIPO risk factors (obesity, COPD, cardiopathy) improves weaning success compared with usual practice.

primary_purpose: Other

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU de Lyon - Hôpital Lyon Sud
CHU de Saint-Etienne
CHU de Lille
CHU de Clermont-Ferrand
CHU de Toulouse
CHU de Montpellier
CHU de Grenoble
CHU de Nantes
CHU de Bordeaux

intervention_type: Other


title: Stent Retriever Versus Contact Aspiration in Irregular Occlusion Phenotype, a Novel Approach in the Endovascular Treatment of Acute Ischemic Stroke: the STRIPE Randomized Trial.

acronym: STRIPE

summary:
Patients with a clinico-neuroradiological mismatch pattern shown on the magnetic resonance imaging/Computed Tomography in the acute phase of stroke are more likely to benefit from reperfusion, are suitable candidates for endovascular therapy, and have a better clinical prognosis.

The ASTER Trial showed similar results between stent-retrievers and contact aspiration concerning the recanalization grade in anterior circulation occlusions. However, we still observe late and futile recanalizations, secondary either to extended ischemic lesions at baseline, long-time procedures or intraprocedural complications. The First Pass Effect that is the complete/nearly complete recanalization after the first maneuver, independently on the technique used, has been strongly associated with better clinical outcomes . In a recent paper we proposed a novel approach to identify those cases that could be treated with a specific technique (stent-retriever) with higher chances to achieve a complete or nearly complete recanalization, with lower procedure times and lower complication rates. This approach is focused on the identification of a regular or irregular phenotype of the occlusion site in patients with an M1-Middle Cerebral Artery occlusion. The phenotype is defined as "regular" whether the profile of the occlusion is abruptly cut without any irregularity and as "irregular" if any irregularity of the profile of the occlusion is observed. One of the hypotheses that could explain these results could be related to the composition of the clot : a soft and less organized clot could be more easily flattened by the pulsatile flow and therefore determine a regular aspect of the occlusion. A more solid and organized clot would, on the contrary, maintain an irregular profile because it would not be flattened by the blood flow and the contrast medium could highlight the irregularities of the proximal face of the clot.

The latter could be a favorable target for the use of a stent-retriever since the interaction between a solid clot and the struts of the stent could increase the chance to retrieve the clot. Therefore, we propose this randomized controlled trial to assess the superiority of stent-retrievers compared to contact aspiration in the treatment of irregular phenotype occlusions of the M1-Middle Cerebral Artery.

lead_sponsor: Hopital Foch

location_facility:
Hôpital FOCH
Chu Nantes
CHU Montpellier
CHU de Reims
CHU de Tours
APHP - Pitié Salpêtrière
Chru Nancy
Chu Bordeaux
Fondation Adolphe de Rothschild

intervention_type: Procedure


title: Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma

summary: The study will assess the safety of the association of NP137 with the standard of care mFOLFIRINOX in the treatment of locally advanced pancreatic ductal adenocarcinoma.The study drug which is tested is the NP137 in association with mFOLFIRINOX to allow a better tumor response as well as better survival outcomes with an acceptable safety.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
NETRIS Pharma

location_facility:
AP-HP Pitié Salpetrière
CHU Rennes
CHRU Lille
CHU de BORDEAUX
CHU Poitiers
CHU de REIMS
Hôpital Privé Jean Mermoz
CHU St Etienne
CHU de GRENOBLE ALPES


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

acronym: FrameLP

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

status: Terminated

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: University Hospital, Toulouse

location_facility: University Hospital of Montpellier Hôpital Gui de Chauliac

location_facility: Fondation Adolphe de Rothschild Hospital

location_facility: University Hospital of Limoges Hôpital Dupuytren 1

location_facility: University Hospital of Nancy (CHRU) Hôpital central

location_facility: University Hospital Pitié-Salpétrière AP-HP

location_facility: University Hospital of Lille Hôpital Roger Salengro

status_simplified: Unknown


title: ProActIF-01 Trial: Randomized Study of Evaluation of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Lung or Digestive Cancers

summary: The ProActIF-01 trial aims to assess the efficacy of a supervised 8-week combined APA and nutrition individualized program on survival without HRQoL deterioration (European Organization for Research and Treatment of Cancer-Quality of Life-C30 questionnaire, EORTC QLQ-C30, 1 targeted dimension), in advanced lung or digestive cancer patients.

primary_purpose: Health Services Research

lead_sponsor: Institut Curie

location_facility: Centre de Lutte Contre le Cancer Jean Perrin

appel_a_projets: PHRCK

region: Île-de-France

nom_etablissement: CLCC  INSTITUT CURIE

type_etablissement: CLCC

titre: ProActIF-01- Etude de phase II randomisée d'évaluation d'un Programme de nutrition et d'Activité physique adaptée Individualisé chez des patients atteints de cancers bronchiques ou digestifs avancés en situation de Fragilité

discipline_principale: cancer

nom_porteur: NEUZILLET

prenom_porteur: Cindy


title: Impact of Simulation-based Training in Addition to Theoretical Training Versus Theoretical Training Alone for Nurses on the Occurring of Adverse Events Related to Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients.

summary:
Currently, the technique of arteriovenous fistula puncture is transmitted by companionship within hemodialysis units. Although the main principles of the technique are well known and common to all hemodialysis units, strong rationales are still lacking to standardize fine practices such as the relative position of the needles, the angle of attack of the needle at puncture, the position of the bevel at the time of puncture and once the needle is in the vascular lumen.

The training of professionals using a simulation-based training program on the approach to arteriovenous fistula puncture, in a process of optimizing practices and continuous improvement of care, while respecting the principles of andragogy, seems to be a suitable tool. This program is built in a multi-professional team from nephrology, nursing and health simulation.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Caen

location_facility: Center Hospital of Memorial United States of St Lo

appel_a_projets: PHRIP

region: Normandie

nom_etablissement: CHU DE CAEN NORMANDIE

type_etablissement: CH

titre: IMPACT D'UNE FORMATION EN SIMULATION PROCEDURALE DES INFIRMIER(E)S DANS LA DIMINUTION DES EVENEMENTS INDESIRABLES LIES A LA PONCTION DE FISTULE ARTERIO VEINEUSE DES PATIENTS HEMODIALYSES CHRONIQUES. ETUDE PROSPECTIVE, COMPARATIVE, RANDOMISEE

discipline_principale: néphrologie

nom_porteur: GUILLOUËT

prenom_porteur: ERWAN


title: Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests

acronym: ELISA

summary:
In image-guided radiotherapy (IGRT), the repeated and increasingly intensive use of on-board positioning imaging, using 2D or 3D Mega-Volt (MV) or kilo-Volt (kV) imaging devices (cone-beam or CBCT scanners), is leading the international medical community to question the potential impact of these additional doses delivered to the patient, especially in at-risk populations such as children and young adults. The doses delivered to the patient by positioning imaging are still relatively unknown, due to the lack of experimental means and software available in clinical routine to easily and accurately evaluate these doses.

The main objective is to estimate by personalized Monte Carlo calculation the physical doses delivered to the patient's organs by the onboard imaging systems during their radiotherapy treatment. The obtained imaging doses will be compared according to different irradiation scenarios commonly used in clinical routine as well as according to the treated location.

study_type: Observational

time_perspective: Retrospective

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Commissariat A L'energie Atomique

location_facility: Institut de Radiothérapie et Radiochirurgie H. Hartmann


title: Reliability Study of a Motor Function Measure Digitalized Playful Completion Modules

acronym: MFM-Play

summary:
Neuromuscular diseases include more than 200 rare disorders affecting muscles or the nervous system. Functional scales assessing motor function are tools allowing to measure the evolution of motor impairment of patients with a neuromuscular disease. They are frequently used as main outcome measures in clinical trials which are currently in full development thanks to advances in genetic and drug researches.

Among the available scales, the Motor Function Measure (MFM), a scale consisting of 32 items, had shown good metrological properties in terms of validity, reliability and sensitivity to change, regardless of the diagnosis and extent of motor impairment.

By exploring the potential of digital technologies applied to MFM, investigators created a completion module composed of animations with different playful and informative scenarios displayed on a digital tablet.

The main purpose of this project is to conduct a multicentre study to assess reliabilities of the MFM completed using the MFM-Play.

Expected benefits of this project are to improve the experience and the participation of the children to who is often imposed multiple assessments during the numerous follow-up visits of clinical trials, while maintaining good metrological properties of the MFM.

time_perspective: Prospective

lead_sponsor: Hospices Civils de Lyon

location_facility: Consultation pluridisciplinaire MNM adulte Hôpital de la Croix Rousse, Groupement Hospitalier Nord HCL

location_facility: Centre de référence des maladies neuromusculaires enfants Hôpital des enfants CHU de Toulouse

location_facility: Service de Rééducation Fonctionnelle Pédiatrique - L'Escale - Hôpital Femme Mère Enfant, Hospices Civils de Lyon

location_facility: Centre de référence maladies neuromusculaires Hôpital Morvan - CHRU de Brest

location_facility: Centre de référence maladies neuromusculaires Hôpital Salengro CHU Lille

location_facility: Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital Bellevue CHU Saint Etienne

location_facility: Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital Couple-Enfant CHU de Grenoble

location_facility: Centre de référence MNM Adulte Saint Etienne - service neurologie CHU Hôpital Nord

location_facility: Consultation de pédiatrie- maladie neuromusculaire Hôpital Armand Trousseau APHP


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

acronym: CATAREV-B

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

lead_sponsor: Institut Cancerologie de l'Ouest

sponsor_collaborators:
Institut Cancerologie de l'Ouest
PHRC-I

location_facility: Institut du Cancer Sainte Catherine Avignon Provence

appel_a_projets: PHRCI

region: Pays de la Loire

nom_etablissement: ICO - SITE PAUL PAPIN

acronyme: CATAREV-B

titre: Conduite à tenir en absence de retour veineux sur chambre implantable avant chimiothérapie en UDJ : phase III randomisée multicentrique.

discipline_principale: autre

nom_porteur: ROLLOT

prenom_porteur: AUDREY


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

acronym: PROPERTY

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

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

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

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

primary_purpose: Prevention

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
Algosource

location_facility:
DIJON UH
Hôpital le Confluent
Nantes Uh
Foch Suresnes Hosptial
Mutaliste Clinic Saint Nazaire
Clermont-Ferrand UH
Chd La Roche Sur Yon
Centre Hospitalier de Cholet
Saint Gregoire Clinique


title: PrOspective inteRventional Study Exploring the mIcrobiota recolONization in Steroid-Refractory Graft-versus-Host Disease Patients Receiving MaaT013

acronym: ORION

summary: The objective of the ORION study is to explore the changes of gut microbiota composition following MaaT013 administration and its impact on the immune system in GVHD patients.

lead_sponsor: MaaT Pharma

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole


title: The NIPA Study: A Randomized Double-blind Control Clinical Trial Naloxegol Administration to Prevent Opioids Induced Gastrointestinal Motility Disturbance in Brain Injured PAtients

acronym: NIPA

summary:
Impaired gastrointestinal transit (IGT) especially constipation, is common among patients under mechanical ventilation, occurring in up to 80 % of the patients during the first week, and has been associated with worse outcome in intensive care unit (ICU). Although IGT in critically ill patients is multifactorial and some components are due to complex disease, there is increasing evidence that exogenous opioids contribute to bowel dysmotility.

Sedatives and especially opioids are largely used in the brain injured population to control intracranial pression, reduce metabolic rate, manage or prevent seizures, and improve mechanical ventilator synchrony. Therefore, brain injured patients are particularly at risk to develop IGT. The occurrence of IGT is associated with adverse outcomes in intensive care unit. Both gastric reflux and impaired peristaltic contractions are associated with ventilator-acquired pneumonia.

The actual challenge is to prevent motility disorders before it occurs. A preventive strategy could in turn reduce the occurrence of complications related to impaired gastrointestinal transit such as ventilator-acquired pneumonia, bacteremia etc. It could also reduce the complications of feed intolerance and thus reduce morbidity and mortality in ICU.

Naloxegol is a polyethylene glycol derivative of naloxol, which is a derivative of naloxone and a peripherally acting µ-opioid receptor antagonist. Contrary to naloxone, naloxegol has a very low penetration into the central nervous system, therefore it could be a relevant option for ileus prevention without the risk of impaired sedation.

The aim of our study is to assess the efficacy of the administration of naloxegol on the onset of early constipation and early ventilator-acquired pneumonia in brain injured patients receiving opioids for analgosedation.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CHU Nantes
Hôpital La Pitié Salpétrière (APHP)
CHU de Strasbourg
CHU Clermont-Ferrand
CHU Tours - Hôpital BRETONNEAU
CHU de Montpellier
CHU Tours - Hôpital TROUSSEAU
CHU Brest
CHU Bordeaux


title: Post Market Clinical Follow-up of EUROSTEM Femoral Stem

summary:
EUROSSTEM is intended for use in primary and revision total hip replacement surgery.

Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

As part of post market vigilance, EUROS will collect data on EUROSTEM performances and safety

status: Active, not recruiting

lead_sponsor: EUROS

location_facility: Hôpital privé Drôme Ardèche - Clinique Pasteur


title: A Randomised Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer

acronym: TRAK-ER

summary:
Detection of molecular relapse with circulating tumour DNA analysis can identify which patients with ER positive breast cancer are relapsing on adjuvant endocrine therapy. This trial will aim to demonstrate that palbociclib and fulvestrant, can defer or prevent relapse in patients with ctDNA detected molecular relapse.

The TRAK-ER trial will have two phases, a ctDNA surveillance phase and a randomised therapy trial in patients with positive ctDNA.

The TRAK-ER trial will establish a ctDNA screening programme for patients with ER positive breast cancer receiving adjuvant endocrine therapy with at least a further three years of standard adjuvant endocrine therapy planned. Patients recruited into the TRAK-ER study will have high-risk clinical features to identify patients at higher risk of future relapse.

ctDNA assays will be used to identify which people are at very high risk of relapse (i.e. those with a positive ctDNA result), and randomise this high risk population between standard endocrine therapy versus palbociclib plus fulvestrant for up to two years.

ReferenceType: background

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oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Turner NC, Slamon DJ, Ro J, Bondarenko I, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Loibl S, Andre F, Puyana Theall K, Huang X, Giorgetti C, Huang Bartlett C, Cristofanilli M. Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2018 Nov 15;379(20):1926-1936. doi: 10.1056/NEJMoa1810527. Epub 2018 Oct 20.

ReferenceCitation: Asghar U, Witkiewicz AK, Turner NC, Knudsen ES. The history and future of targeting cyclin-dependent kinases in cancer therapy. Nat Rev Drug Discov. 2015 Feb;14(2):130-46. doi: 10.1038/nrd4504.

ReferenceCitation: Di Leo A, Jerusalem G, Petruzelka L, Torres R, Bondarenko IN, Khasanov R, Verhoeven D, Pedrini JL, Smirnova I, Lichinitser MR, Pendergrass K, Garnett S, Lindemann JP, Sapunar F, Martin M. Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol. 2010 Oct 20;28(30):4594-600. doi: 10.1200/JCO.2010.28.8415. Epub 2010 Sep 20. Erratum In: J Clin Oncol. 2011 Jun 1;29(16):2293.

ReferenceCitation: Di Leo A, Jerusalem G, Petruzelka L, Torres R, Bondarenko IN, Khasanov R, Verhoeven D, Pedrini JL, Smirnova I, Lichinitser MR, Pendergrass K, Malorni L, Garnett S, Rukazenkov Y, Martin M. Final overall survival: fulvestrant 500 mg vs 250 mg in the randomized CONFIRM trial. J Natl Cancer Inst. 2014 Jan;106(1):djt337. doi: 10.1093/jnci/djt337. Epub 2013 Dec 7.

lead_sponsor: Royal Marsden NHS Foundation Trust

collaborators: Institute of Cancer Research, United Kingdom

collaborators: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
United Kingdom
France

location_facility: Oxford Cancer & Haematology Centre, Churchill Hospital,

location_facility: Institut du Cancer Avignon Sainte Catherine

location_facility: University Hospitals Dorset: Royal Bournemouth Hospital

location_facility: University Hospitals Dorset: Poole Hospital

location_facility: North West Anglia NHS Foundation Trust: Peterborough Hospital

location_facility: Nottingham University Hopsitals NHS Trust

location_facility: North West Anglia NHS Foundation Trust: Hinchingbrooke Hospital

nom_etablissement: GCS UNICANCER SIEGE

type_etablissement: GCS

acronyme: TRAK ER

titre: TRAK ER-Etude randomisée de détection précoce des rechutes moléculaires par suivi de l'ADN tumoral circulant et traitement par palbociclib plus fulvestrant versus traitement endocrinien standard chez les patientes atteintes d'un cancer du sein ER-positif HER2-négatif

nom_porteur: ANDRE

prenom_porteur: Fabrice


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

acronym: CIRCULAR

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

primary_purpose: Screening

lead_sponsor: Institut Bergonié

sponsor_collaborators:
Institut Bergonié
AstraZeneca

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

intervention_type: Diagnostic Test


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

acronym: PANDA-H

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

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

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

appel_a_projets: PHRCN

nom_etablissement: CHU DE NANTES

acronyme: PANDAH

titre: Évaluation de l'efficacité d'un Programme d'Accompagnement Numérique aux Devoirs à la maison pour enfants tdAH  Essai contrôlé, randomisé, en ouvert, sur groupes parallèles

discipline_principale: psychiatrie / addictologie

nom_porteur: Bonnot

prenom_porteur: Olvier


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

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

status: Completed

lead_sponsor: Proteor Group

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

status_simplified: Completed


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

acronym: CovidEP

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

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

status: Unknown status

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

location_facility: Groupement Hospitalier Porte de Valence - Montélimar


acronym: IMMUNOGAST

summary:
For patients with advanced/metastatic gastric adenocarcinomas in progression after a first line chemotherapy comprising platinum and fluoropyrimidine, the reported second line treatments are : 1) paclitaxel combined with ramucirumab (overall response rate (ORR) = 25%; median progression free survival (PFS) = 2.9 months; median overall survival (OS)= 5.9 months), or paclitaxel alone (ORR = 14%, median PFS = 2.9 months; median OS= 5.9 months); 2) docetaxel (ORR = 7%, median OS = 5.2 months) or 3) irinotecan (ORR = 0%, median OS= 4.0 months).

These numbers demonstrate the poor prognosis of this disease, and the unmet medical need for innovative therapeutic strategies.

Cancer Genome Atlas (TCGA) mapped a genomic landscape of gastric adenocarcinomas, and identified 4 sub-types:

Tumor positive for Epstein-Barr virus (EBV) (8%), which display recurrent PIK3CA mutations, extreme DNA hypermethylation, and amplification of JAK2, ErbB2, PD-L1 and PD-L2;
Microsatellite instable tumors (MSI-high) (22%), which show elevated mutation rates, including mutations of genes encoding targetable oncogenic signaling proteins (PIK3CA, ErbB2, ErbB3, and EGFR);
Genomically stable tumors (20%), which are enriched for the diffuse histological variant and mutations of RHOA or fusions involving RHO-family GTPase-activating proteins;
Tumors with chromosomal instability (50%), which show marked aneuploidy and focal amplification of receptor tyrosine kinases and VEGFA.

Most of diffuse-type gastric adenocarcinomas were classified in genomically stable tumors. This subgroup of cancers, accounting for about 20 to 30% of gastric adenocarcinomas, is associated with particularly poor prognosis and resistance to chemotherapy. A proteomic landscape of diffuse-type gastric adenocarcinomas was recently reported.

Pembrolizumab, an anti-PDL1 drug granted with an accelerated approval by FDA in September 2017, exhibited promising activity in gastric adenocarcinoma patients previously treated with 1 or 2 lines of chemotherapy (ORR=11.6%, median PFS = 2.0 months, median OS= 5.6 months), especially in those with PDL1 positive tumors (ORR=22.7%). The tumor response was particularly high in patients with MSI-high tumor (ORR=57.1%). However the preliminary outcomes of the phase III KEYNOTE-061 trial (NCT02370498) recently released in the press suggest that pembrolizumab was not superior to paclitaxel in 592 patients with advanced gastric or gastroesophageal junction adenocarcinoma whose disease progressed after first-line treatment with platinum and fluoropyrimidine doublet therapy (the hazard ratio (HR) for OS was 0.82 (95% confidence interval = 0.66-1.03; one sided P = .042) (http://www.ascopost.com/News/58377).

These outcomes suggest that, although being very promising, immunotherapy should be combined to other agents for being fully effective in gastric adenocarcinomas patients.

We propose a strategy based on molecular features to select the drugs that will be associated with atezolizumab, an anti-PDL1 drug, in patients with pre-treated advanced gastric adenocarcinomas:

Patients with tumors positive for EBV or microsatellite instable tumors (30%) will be treated with atezolizumab and ipatasertib.
Patients with genomically stable tumors (20%) will be treated with atezolizumab combined with bevacizumab.
Patients with tumors with chromosomal instability (50%) will be treated with atezolizumab combined with bevacizumab.

Expected outcomes:

IMMUNOGAST trial will provide data about the clinical feasibility of biomolecular characterization of gastric adenocarcinomas for routine treatment adjustment. Moreover it should generate information about the relevance of adjusting combined immunotherapies based on molecular subtypes, in terms of clinical efficacy. Finally, translational research project outcomes should provide important data about relationships between efficacy and tumor immune gene spatial expression, along with tumor and circulating mutational burden. These outcomes may help identify the best candidates for tested combinations in the future.

location_facility:
Hcl - Hopital Edouard Herriot
Aphm - Hopital La Timone
Bordeaux - Hopital Haut-Leveque
Dijon - Centre Georges-Francois Leclerc
Aphp - Hopital Saint-Louis
Hcl - Centre Hospitalier Lyon Sud
Toulouse - Iuct Rangueil-Larrey
Aphp - Hopital Pitie Salpetriere

title: An Umbrella Phase 2 Trial to Assess Personalized Targeted IMMUNOtherapy-based Regimens in Recurrent Advanced/Metastatic GASTric Adenocarcinoma Patients

type: EudraCT Number

source: euctr

design_allocation: Non-Randomized


title: SPONDIMMO : Multicentered Descriptive Prospective Study of Immobilization and Neurological Complication in Patients With Vertebral Osteomyelitis.

acronym: SPONDIMMO

summary:
Vertebral osteomyelitis is an infection of the intervertebral disk and adjacent vertebral plates with a non-negligible risk of neurological complications and handicap. If there are clear recommendations dealing with antibiotic therapy and surgery indications for this pathogen, the question of the immobilization will be remaining debate. The aim of the study was to describe protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers. The secondary objectives were to evaluate the frequency of neurological complications in a large prospective cohort, and to identify clinical and imaging risk factors for neurological complications.

The investigators also aim to search for association between type and duration of spine immobilization and neurological status at the end of follow-up.

location_facility:
La Roche Sur Yon Hospital
Nantes University Hospital
Tours University Hospital
Paris University Hospital
Angers University Hospital
Rennes University Hospital
Clermont ferrand University Hospital
Saint-Nazaire Hospital
Quimper Hospital


title: A Randomised, Open-label, Multicentre, Phase 3 Trial of First-line Treatment With Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects With Steroid-refractory Acute Graft-versus-host Disease After Allogeneic Haematopoietic Stem Cell Transplantation (IDUNN Trial)

acronym: IDUNN

summary: The primary purpose of this trial is to demonstrate the superiority of MC0518 compared to the first used best available therapy (BAT) with respect to overall response rate (ORR) at Day 28 and/or overall survival (OS) until Visit Month 24 in adult and adolescent subjects with steroid-refractory acute graft-versus-host disease (SR-aGvHD).

lead_sponsor: medac GmbH

location_country: Germany France Poland Spain Sweden

location_facility: Universitaetsklinikum Wuerzburg - Medizinische Klinik und Poliklinik II - Zentrum fuer Allogene Blutstammzelltransplantation

location_facility: Department of Pediatric Hematology, Oncology and BMT, Wroclaw Medical University

location_facility: CHU Jean Minjoz Boulevard Fleming Besancon

location_facility: Center for Allogeneic Stem Cell Transplantation and Cell Therapy (CAST), Karolinska Universitetssjukhuset Huddinge

location_facility: Klinikum der Johann Wolfgang Goethe University

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud Avenue Rene Laennec Amiens

location_facility: CHU de Nantes - Hotel Dieu 1 Place Alexis Ricordeau Nantes

location_facility: University Hospital Bonn, Medizinische Klinik III

location_facility: Selbststaendige Abteilung fur Haematologie und Internistische Onkologie

location_facility: Hospital Universitari i politecnic La Fe

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet - Frankfurt am Main

location_facility: University Hospital Tuebingen Medical Center

location_facility: Centre Hospitalier Lyon Sud Pavillon Marcel Berard 1G

location_facility: Universitaetsklinikum Essen - Klinik fuer Knochenmarktransplantation (KMT)

location_facility: Universitaetsklinikum Freiburg - Zentrum fuer Kinder- und Jugendmedizin (ZKJ) - Klinik fuer Paediatrische Haematologie und Onkologie

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre Hospitalier Universitaire CHU de Toulouse

intervention_type: Biological


title: A Multicenter, Prospective, Multi-organ Study to Evaluate the Clinical Benefit of an Exome "Complex" Analysis Versus an Exome "Simple" Analysis to Help the Therapeutic Decision for the Precision Medicine

summary:
The "simple" analysis of the exome can determine somatic and constitutional mutations. The major challenge lies in the translation of sequencing data into clinically relevant information allowing the clinician to guide his decision-making A "complex" analysis of the exome would provide access to structural DNA data, concerning mutational signatures, tumor mutational load, analysis of large deletions, loss of heterozygosity as well as amplification of certain genes which may have an impact on the management of patients.

No data available to date makes it possible to assess the clinical interest of the availability of its additional information resulting from a "complex" analysis compared to a "simple" analysis. The objective of the EXOMA2 study is to assess the proportion of patients for whom the proposed therapy is derived from its additional information (complex analysis) and would not have been possible with a classic exome analysis (simple analysis) .

We hereby formulate the hypothesis that a "complex" analysis on a population presenting a metastatic or locally advanced disease treated early (from the 1st line of treatment) will make it possible to determine therapeutic indications which could not be discovered with a "simple" analysis.

primary_purpose: Diagnostic

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
CHU Nantes
CHRU Jean Minjoz
CHU François Mitterrand
Chu Poitiers
Institut Bergonie
Institut Hospitalier Franco-Britannique
Centre Oscar Lambret
CHU Amiens Picardie
CGFL

intervention_type: Genetic


title: HFNO or Conventional Oxygen Therapy for Patients With Acute Hypoxemic Respiratory Distress

acronym: HIFLOWED

summary:
A quarter of the patients admitted to the Shock Room or Resuscitation Room of an Emergency Department (ED) are admitted for severe hypoxemia resulting from acute respiratory distress. Like all life-threatening conditions, acute respiratory distress (ARD) requires a rapid identification and a prompt implementation of effective resuscitation measures.

Oxygen treatment, first described in 1890, remains one of the most important discoveries in medicine. The purpose of oxygenation is to alleviate respiratory failure and to restore a satisfactory hematosis. The choice of the oxygen delivery device is based on the severity of the hypoxemia, the underlying physiological problems, the type of dyspnea and the patient's tolerance to the device. The most commonly used devices are nasal cannula, face mask and high-concentration face mask (conventional oxygen therapy). High Flow Nasal Oxygen (HFNO) is now widely used as a complement to conventional oxygen therapy in the EDs.

HFNO ensures good clinical tolerance and better patient comfort (humidification and heating of inhaled gases...) than the other oxygen devices. The HFNO flow rate can go up to 60-70 L/min with an FIO2 (fraction of inspired oxygen inspired oxygen fraction) of 100% compared to a maximum output of 15 L/min with conventional oxygen-therapy.

Given the lack of data and clinical trials concerning the systematic use of HFNO in EDs in cases of severe hypoxemia, a prospective study is essential. The purpose of this work is to evaluate the contribution of early administration of HFNO for patients with acute non-hypercapnic respiratory distress presenting in the ED, with the aim of obtaining rapid correction of hematosis. The objective of this work is to compare Conventional Oxygen Therapy (CO) delivered by nasal cannula or nasal-oral mask at flow rates up to a maximum of 15 liters, to HFNO with the hypothesis that HFNO would reduce the need for ventilation therapy escalation. The other hypotheses concern the interest of the HFNO in reducing the use of intensive care hospitalization and thus the costs of treating these patients.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

collaborators: centre Hospitalier Intercommunal de Vesoul

collaborators: Centre Hospitalier Universitaire de Saint Louis APHP

location_facility:
University Hospital of Dijon
University Hospital of Lariboisière
University Hospital of Rennes
University Hospital of Besançon
Hospital of Vesoul
Hospital of Chartres
University Hospital of Toulouse
University Hospital of Clermont Ferrand
University Hospital of Poitiers

region: Bourgogne-Franche-Comté

nom_etablissement: CHU BESANCON

acronyme: HIFLOWED

titre: Oxygénothérapie Nasale à Haut Débit chez les patients en Détresse Respiratoire Aigüe à l'accueil du service des urgences.

discipline_principale: soins primaires

nom_porteur: KHOURY

prenom_porteur: Abdo


title: Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men and Using Oral Tenofovir Disoproxil Fumarate/ Emtricitabine (TDF/FTC) for HIV Pre-Exposure Prophylaxis (PrEP)

acronym: DOXYVAC

summary: The study ANRS 174 Doxyvac is a clinical trial that will use Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex with Men and using oral TDF/FTC for HIV Pre-Exposure Prophylaxis (PrEP) and vaccination with Bexsero.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
Hôpital pitié Salpetrière
Hôpital Saint-Louis
Hôpital Européen Georges Pompidou
Hôpital Hôtel Dieu
Hôpital Tenon
Hôpital Pitié-Salpétrière
Hôpital Bichat
Hôpital Necker-Enfants Malades
Hôpital Saint-Antoine


title: Anti-αIIbβ3 Immunization in Glanzmann Thrombasthenia: Prevalence and Associated Risk Factors: Thrombasthenia Anti-αIIbβ3 Antibodies Study (TAAS)

acronym: TAAS

summary: This project aim to correlate risk factors (genetic, therapeutic and socio-demographic factors) to anti-αIIbβ3 antibodies formation following blood products transfusion (platelets or packed red cells) or pregnancy in a national cohort of GT patients.

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU Bordeaux - Hôpital Pellegrin
Hôpital Bicêtre, APHP
CHU Bordeaux - Hôpital Haut-Lévêque
CHU Toulouse
CHU Nîmes
CHU Poitiers
CHU Limoges
CHU Strasbourg
Hôpital la Timone, APHM


title: Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy

summary:
CESTO 2 is a 318 participants, 3-arm, multicentric, randomized, double-blind, placebo-controlled Phase II clinical trial.

The main objectives are to select the most efficient dose and to assess long-term efficacy of NFL-101 compared to placebo, for abrupt cessation and for reduction before cessation.

lead_sponsor: NFL Biosciences SAS

location_facility: Centre d'Investigation Clinique de Marseille Nord

location_facility: Centre d'Investigation Clinique de Poitiers (CIC 1402)

location_facility: Centre d'Investigation Clinique de Montpellier

location_facility: Centre d'Investigation Clinique de Rennes

location_facility: Centre d'Investigation Clinique de Bordeaux

location_facility: Centre d'Investigation Clinique de Clermont-Ferrand


title: COVID 19 : Seroprevalence Study of Anti SRAS-CoV-2 Antibodies in GHT Employees in Haute Bretagne

acronym: AntiCoV-HB

summary: Since the start of this epidemic, numerous clinical and fundamental studies have been conducted to best adapt the individual management of COVID-19 cases [1-6]. In parallel with this work, it is necessary to better understand the characteristics of the epidemic in the general population but also in the population working in healthcare settings more exposed to SARS-CoV-2. Seroprevalence studies are therefore particularly useful in order to understand the collective immunization rate and the factors that can explain this immunization.

ReferenceType: result

ReferenceCitation: Garlantezec R, Heslan C, Tadie E, Tattevin P, Thibault V, Paris C. A lateral flow immunoassay test performance in SARS-CoV-2 seroprevalence surveys: a validation study among healthcare workers. Emerg Microbes Infect. 2020 Dec;9(1):2547-2549. doi: 10.1080/22221751.2020.1852893.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

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

repository_normalized: HAL

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

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

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Informa

ReferenceCitation: Garlantezec R, Tadie E, Heslan C, Gary-Bobo P, Oumari S, Saade A, Sitruk A, Tattevin P, Thibault V, Paris C; AntiCOV-HB* working group. SARS-CoV-2 seroprevalence and antibodies persistence among health care workers after the first COVID-19 wave in nine hospitals in Western France. Infect Dis Now. 2022 Nov;52(8):447-452. doi: 10.1016/j.idnow.2022.09.004. Epub 2022 Sep 13.

oa_host_type: repository

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

version: submittedVersion

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: Paris C, Tadie E, Heslan C, Gary-Bobo P, Oumari S, Saade A, Sitruk A, Wild P, Thibault V, Tattevin P, Garlantezec R. Risk factors for SARS-CoV-2 infection among health care workers. Am J Infect Control. 2022 Apr;50(4):375-382. doi: 10.1016/j.ajic.2021.11.001. Epub 2021 Nov 12.

oa_colors: green other

evidence: open (via free pdf)

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

license: cc-by-nc

license_normalized: cc-by-nc

sponsor_collaborators:
Rennes University Hospital
Fonds NOMINOE

location_facility: CENTRE HOSPITALIER de VITRE_ Saint Jean (La Guerche)


title: COvid-19 and Vitamin D Supplementation: a Multicenter Randomized Controlled Trial of High Dose Versus Standard Dose Vitamin D3 in High-risk COVID-19 Patients (CoVitTrial)

summary:
Vitamin D is a secosteroid hormone produced by the skin during Summer exposure to UVB rays. Hypovitaminosis D is common in Winter (October to March) at Northern latitudes above 20 degrees North, and from April to September at Southern latitudes beyond 20 degrees below the equator.

In the past, coronaviruses and influenza viruses have exhibited very high seasonality, with outbreaks occurring preferentially during the Winter. The Covid-19 pandemic is indeed more severe above Winter latitudes of 20 degrees, while it remains until now less severe in the Southern hemisphere, with a much lower number of deaths.

Preclinical research suggests that the SARS-Cov-2 virus enters cells via the angiotensin converting enzyme 2 (ACE2). Coronavirus viral replication downregulates ACE2, thereby dysregulating the renin-angiotensin system (RAS) and leading to a cytokine storm in the host, causing acute respiratory distress syndrome (ARDS).

Research also shows that vitamin D plays a role in balancing RAS and in reducing lung damage. On the contrary, chronic hypovitaminosis D induces pulmonary fibrosis through activation of RAS. Similarly, hypovitaminosis D has been strongly associated in the literature with ARDS, as well as with a pejorative vital prognosis in resuscitation but also in geriatric units, and with various comorbidities associated to deaths during SARS-Cov-2 infections. Conversely, vitamin D supplementation has been reported to increase immunity and to reduce inflammatory responses and the risk of acute respiratory tract infections.

High-dose oral vitamin D3 supplementation has been shown to decrease short-term mortality in resuscitation patients with severe hypovitaminosis D (17% absolute risk reduction). It is considered safe to take oral vitamin D supplementation at doses up to 10,000 IU/day for short periods, particularly in older adults, i.e. a population that is mostly affected by hypovitaminosis D and who should receive at least 1,500 IU of vitamin D daily to ensure satisfactory vitamin D status.

Vitamin D supplementation is mentioned as a potentially interesting treatment for SARS-Cov-2 infection but on a scientific basis with a low level of evidence until now.

We hypothesize that high-dose vitamin D supplementation improves the prognosis of older patients diagnosed with COVID-19 compared to a standard dose of vitamin D.

ReferenceType: derived

ReferenceCitation: Annweiler C, Beaudenon M, Gautier J, Gonsard J, Boucher S, Chapelet G, Darsonval A, Fougere B, Guerin O, Houvet M, Menager P, Roubaud-Baudron C, Tchalla A, Souberbielle JC, Riou J, Parot-Schinkel E, Celarier T; COVIT-TRIAL study group. High-dose versus standard-dose vitamin D supplementation in older adults with COVID-19 (COVIT-TRIAL): A multicenter, open-label, randomized controlled superiority trial. PLoS Med. 2022 May 31;19(5):e1003999. doi: 10.1371/journal.pmed.1003999. eCollection 2022 May.

repositories_concat: PubMed Central

publisher_dissemination: Public Library of Science

ReferenceCitation: Shakoor H, Feehan J, Al Dhaheri AS, Cheikh Ismail L, Ali HI, Alhebshi SH, Apostolopoulos V, Stojanovska L. Role of vitamin D supplementation in aging patients with COVID-19. Maturitas. 2021 Oct;152:63-65. doi: 10.1016/j.maturitas.2021.03.006. Epub 2021 Mar 16. No abstract available.

ReferenceCitation: Annweiler C, Beaudenon M, Gautier J, Simon R, Dubee V, Gonsard J, Parot-Schinkel E; COVIT-TRIAL study group. COvid-19 and high-dose VITamin D supplementation TRIAL in high-risk older patients (COVIT-TRIAL): study protocol for a randomized controlled trial. Trials. 2020 Dec 28;21(1):1031. doi: 10.1186/s13063-020-04928-5.

publisher_dissemination: Springer-Nature

lead_sponsor: University Hospital, Angers

sponsor_collaborators:
University Hospital, Angers
Mylan Laboratories

location_facility:
CH Le Mans
CHU Nantes
CHU Nice
CHU Tours
CHU Saint Etienne
CHU Bordeaux
CHU Limoges
CH Saumur
CHU Angers


type: Registry Identifier

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

acronym: PRETORIA

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

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

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

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

ReferenceCitation: Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0.

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

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

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

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


acronym: COVIDAXIS

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

summary:
Since December 2019, the emergence of a new coronavirus named SARS-Cov-2 in the city of Wuhan in China has been responsible for a major epidemic of respiratory infections, including severe pneumonia. Within weeks, COVID-19 became a pandemic.

In the absence of specific antiviral treatment, a special attention should be given to prevention. Personal protection equipments may be insufficiently protective, including in healthcare workers, a significant proportion of whom (around 4%) having been infected in the outbreaks described in China and more recently in Italy. Infection in healthcare workers could result from the contact with COVID-19 people in community or with infected colleagues or patients.

As it will take at least a year before vaccines against SARS-CoV-2 becomes available, chemoprophylaxis is an option that should be considered in this setting where prevention of SARS-CoV-2 infection in Health Care Workers.

The COVIDAXIS trial evaluates a chemoprophylaxis of SARS-CoV-2 infection in Health Care Workers. This trial is divided into two distinct studies that could start independently each with its own randomization process: COVIDAXIS 1 will study Hydroxychloroquine (HCQ) versus placebo; COVIDAXIS 2 will study Lopinavir/ritonavir (LPV/r) versus placebo.

Upon randomization healthcare workers (HCWs) involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:

location_facility:
CHU de Nancy
CHU de Saint-Etienne
CHU de Clermont-Ferrand
CHU de Montpellier
CHU d'Angers
CHU de Rennes
CHU de Rouen
CHU de Nantes
CHU de Bordeaux

title: Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers : A Randomized Double-blind Placebo-controlled Clinical Trial


title: A Randomized, Prospective, Post-market, Multicenter Study to Evaluate the Potential Benefit of Side Branch Ballooning, in the Setting of Single Stenting With Systematic Proximal Optimization Technique, in the Treatment of Bifurcation Lesion

acronym: KISS

summary: KISS study is an investigator-initiated, multi-centre, prospective, randomized (1:1), parallel, two-arm, non-inferiority trial aiming to compare two bifurcation PCI procedures for Side Branch protection

lead_sponsor: Ceric Sàrl

location_country:
Italy
Portugal
United Kingdom
Switzerland
Spain
France

location_facility: CHUV Centre Hospitalier Universitaire Vaudois


title: Liver and Metabolic Effects of Insulin Pump Therapy in a Population of Type 2 Diabetics With Non-alcoholic Hepatic Steatosis

acronym: STEATO-POMPE

summary:
The prevalence of fatty liver disease (NAFLD: Non-Alcoholic Fatty Liver Disease or to a more severe degree NASH: Non-Alcoholic SteatoHepatitis) reached 40-70% in subjects with type 2 diabetes (T2D). NAFLD can be easily detected by performing a hepatic ultrasonography. The presence of a NAFLD is positively correlated with the severity of insulin resistance and dysglycemia in this population. The presence of NAFLD worsens the prognosis of T2D with an increased cardiovascular risk. This hepatic impairment would also increase the risk of microvascular complications, especially nephropathy. Conversely, T2D increases the risk of transition from NAFLD to NASH and then to hepatic fibrosis and its related complications (cirrhosis, hepatocellular carcinoma). The risk of progression of liver steatosis to fibrosis is also more important as diabetes and insulin resistance are more severe.

In addition to diabetes and insulin resistance, other risk factors are associated with more severe liver damage such as changes in microbiota. Indeed, it has already been described a smaller amount of bacteroides in the microbiota of subjects with T2D and the most severe hepatic impairment. The treatment of NAFLD/NASH is poorly codified without approved drugs in this indication, while many phase 3 trials with candidate drugs are undergoing. Life-style measures (physical activity and low carbohydrate/calorie diet) can limit the progression from NAFLD to more severe liver fibrosis. Some bariatric surgery studies have also shown good results in this situation. Pharmacological interventions are also reported with proven efficacy of pioglitazone, vitamin E and orlistat.

The OPT2MISE study has recently shown the superiority of insulin pump (or continuous sub-cutaneous insulin infusion: CSII) compared to multiple daily insulin injections (MDI) to improve glycemic control in a population of patients with T2D in failure of well-titrated MDI. In addition, treatment with CSII showed a 45% decrease in insulin resistance (assessed by HOMA-IR) in a population of newly diagnosed T2D.

In light of these data, investigators hypothesize that the introduction of insulin pump treatment in a population of subjects with T2D and NAFLD, by improving insulin sensitivity, could reduce fatty liver content compared to standard MDI treatment.

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
University Hospital, Angers

location_facility:
CHU
CHU de Rennes
Nantes UH
Hospices Civils


title: Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy in a Randomized Trial for 3 Months Followed by an Extension Period

acronym: DIABELOOP SP8

summary:
This clinical trial is a randomized trial including a 3-month single-arm part and a 6-month extension phase.

Following randomization between the 1st group and 2nd group, a 2-week baseline period in open-loop for 148 adults and 30 adolescents will be performed. Patients will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6.

Then, a 3-month study phase will be performed during 12 weeks:

1st group (111 adults randomized from 148 adults and 30 adolescents) will receive the treatment via the Closed-loop System (closed-loop condition).
2nd group (37 adult controls randomized from 148 adults) will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6 (open loop condition).
An extension period of 6 months with the Closed-loop System (closed-loop condition) will be performed at the end of the study phase for all patients enrolled.

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

location_facility: Marseille - La Conception University Hospital

location_facility: Necker-Enfants Malades University Hospital


title: Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection in Labia Majora for Volume Restoration

acronym: ESOLANE

summary:
DESIRIAL® PLUS is a CE-marketed hyaluronic acid (since 2011) whose registered indications are moderate hypotrophy, severe hypotrophy or atrophy of the vulvar Labia Majora by subcutaneous injections. The aim is to restore volume, rehydrate and add tone and tension to connective tissue areas by filling.

In this study, 71 female subjects above or equal to 18 years old at inclusion, who have moderate hypotrophy or severe hypotrophy or atrophy of the vulvar Labia Majora (according to investigator's judgement), who have given her informed consent and meet all the eligibility criteria, will be enrolled. Subjects will come to a total of 6 visits over a period of 12 months. An optional screening visit may be done before injection (additional visit). Proportion of patients having an improved perception of aesthetics (GAIS score after mirror self-examination) after baseline injection will be assessed. Global Aesthetic Improvement, Sexual function, subject's satisfaction, subject's symptoms, pain at injection and safety will be also assessed.

lead_sponsor: Laboratoires Vivacy

location_facility:
Centre de la femme
Chu Henri Mondor
Private office
CHU Croix-Rousse
Clinique de l'Europe


title: MOdalities of Use, effectiveNEss and TOlerability of Eqwilate® a Balanced combInatiON of VWF and FVIII in Von WillEbrand Patients in Real-life Conditions: the ONE-TO-ONE Study

summary: MOdalities of use, effectiveNEss and TOlerability of Eqwilate® a balanced combInatiON of VWF and FVIII in von WillEbrand patients in real-life conditions: the ONE-TO-ONE study

lead_sponsor: Octapharma

location_facility:
Rennes Study Site
Saint-Etienne Study Site
Paris Study Site - Lariboisiere
Rouen Study Site
Caen Study Site
Saint Denis Study Site - Pediatrie
Clamart Study Site
Saint Denis Study Site
Paris Study Site - Necker


title: Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease

acronym: COMADHAA

summary: Alcoholic hepatitis carries a risk of high mortality at short term, especially in its severe form. Its diagnosis is confirmed by liver biopsy. The prevalence of alcoholic hepatitis, severe or not severe, is poorly known and prospective data are needed. The present observational study aims to define the prevalence of alcoholic hepatitis among patients admitted for jaundice and determine their outcome according to the severity. Survival and markers of liver dysfunction will be assessed. A biobank including genetic samples will be created to identify the disease profile in terms of inflammation and regeneration. The performance of non-invasive criteria for diagnosis will also be studied.

lead_sponsor: University Hospital, Lille

location_facility: Hu Est Parisien Site St Antoine Aphp - Paris 12

location_facility: Association Hopital Saint Joseph - Marseille


title: Low-voltage Areas Defragmentation in Sinus Rhythm for Radiofrequency Ablation of Persistent Atrial Fibrillation

acronym: SCAR-AF

summary: This is a study evaluating the value of defragmentation of sinus rhythmic low voltage areas in addition to isolation of pulmonary veins in the removal of recurrent atrial fibrillation. The invasive procedure will be performed according to the procedures chosen by the rhythmologist and will in no way be modified by the patient's enrollment in the study. Similarly, the frequency of consultations, date and nature of the additional examinations will be defined by the physician, with the purpose of monitoring the patient.

lead_sponsor: French Cardiology Society

location_facility: Clinique de l'Infirmerie Protestante de Lyon

location_facility: Centre Hospitalier Saint Joseph Saint Luc

location_facility: Centre Hospitalier Universitaire d'Angers


title: A GINECO Phase II Trialo Assessing the Safety and the Efficacy of the Bevacizumab, Olaparib and Durvalumab (MEDI 4736) Combination in Patients With Advanced Epithelial Ovarian Cancer in Relapse

acronym: BOLD

summary: Assessing the safety and efficacy of the bevacizumab, Olaparib and Durvalumab (MEDI 4736) combination in patient with high grade serous or high grade endometrioid or other high grade epithelial non mucinous ovarian tumor, with at least one previous line of platinum-taxane chemotherapy, and present with platinum resistant disease (PRR) or platinum-sensitive relapse (PSR), whatever the line of chemotherapy given at relapse.

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Groupe Hospitalier des Diaconesses Croix Saint-Simon


title: Randomized Controlled Trial Evaluating the Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology

acronym: EDHITO

summary: The aim of this therapeutic education program is to reduce the apparition of immune-related Adverse Event with patients treated with ICI

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Centre D'Oncologie Et de Radiotherapie 37

intervention_type: Behavioral

acronyme: EDHITO

titre: Etude randomisée contrôlée évaluant l'impact de l'EDucation THérapeutique du patIent sur la TOxicité des inhibiteurs du checkpoint immunitaire en oncologie

discipline_principale: pneumologie

nom_porteur: BEAUMONT

prenom_porteur: Nathalie


title: Evaluation of an Optimization Protocol for Diuretics in the Decompensation of Chronic Heart Failure: Randomized Trial in Clusters With Sequential Permutation

acronym: ProDUCT-HF

summary: The main objective of the study is to determine if a diuretic adaptation protocol in the decompensation of chronic heart failure is more effective but also safer than the current non-protocolized practice.

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
University Hospital, Grenoble
Hospices Civils de Lyon
Hôpital de la Croix-Rousse
CH Puy en Velay
CH Moulins-Yzeure
CH Riom
Infirmerie Protestante de Lyon
CH Issoire
CH Annecy Genevois

location_facility:
CH RIOM
CH PUY
Ch Issoire
CHU de GRENOBLE
Chu Clermont-Ferrand
Infirmerie Protestante de Lyon
Ch Annecy
Ch Moulins
Ch Lyon Sud


title: Vaginal Native Tissues Repair for Pelvic Organ Prolapse

acronym: TAPP

summary: The aim of the study is to assess at one year the effectiveness of the vaginal patch plastron in comparison of the anterior colporraphy through a combined definition of success: anatomic and functional.

ReferenceCitation: Lacorre A, Vidal F, Campagne-Loiseau S, Marin B, Aubard Y, Siegerth F, Mesnard C, Chantalat E, Hocke C, Gauthier T. Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial. Trials. 2020 Jul 8;21(1):624. doi: 10.1186/s13063-020-04512-x.

repository_institution: PubMed Central - Europe PMC

lead_sponsor: University Hospital, Limoges

location_facility:
CHU de Toulouse - Paule de Viguier
CHU de Saint-Etienne
CH de Gueret
CH de Brive
CHU de Limoges
CHU de Toulouse - Rangueil
CH de Tulle
CHU de Bordeaux
CHU de Clermont Ferrand

region: Nouvelle-Aquitaine

nom_etablissement: CHU  DE  LIMOGES

acronyme: TAPP

titre: Tratitement autologue du prolapsus

discipline_principale: tissu autologue, plastron vaginal sous vésical, technique de marion kelly, résultats anatomiques et fonctionnels, prolapsus

nom_porteur: LACORRE

prenom_porteur: Aymeline


title: A Prospective Multicenter, Comparative, Randomized, Double-blind, Non-inferiority Study of Eyestil® Plus Multidose Versus Vismed Multi® in Patients With Moderate to Severe Dry Eye Syndrome

summary:
SIFI SpA had developed Eyestil Plus®. It is sterile eyedrops without preservatives with a physiological pH containing sodium hyaluronate. Its intended purpose is to moisturize, lubricate and protect the ocular surface and gives temporary relief to burning, irritation and dry eye-related discomfort, and other complaints induced, for example, by: prolonged use of either soft, semi rigid or rigid contact lenses; exposure to environmental factors (air conditioning, exposure to solar radiation, wind, smoke, pollution, severe climatic conditions, dust); ocular fatigue caused by studying, working, driving or prolonged exposure to electronic devices.

Eyestil Plus® is CE marked but not available yet in all European countries. Considering the European regulatory change on medical devices - from a Directive (Directive 1993/42/EEC) to a Regulation (MDR 2017/745) that now requires clinical evidence of device performance and safety; SIFI Spa decided to implement the present clinical comparative performance study. The choice of Vismed Multi® as the comparator has been done since it is the current French standard of care treatment for patients with moderate to severe dry eyes.

lead_sponsor: SIFI SpA

location_country: Spain France

location_facility:
Centre Monticelli
Chu Morvan
CHU de Nice - Hôpital Pasteur
Hopital Bretonneau
Hospital Universitario Virgen Macarena
Hôpital de la Croix Rousse
CHU de Bordeaux - Hôpital Pellegrin
Instituto Oftalmologico Fernandez-Vega
Hospital Recoletas Campo Grande
Hopital La Timone Adultes
CHU François Mitterand
CHU Saint Etienne/Hôpital Nord


title: Nal-IRI/LV5-FU VERSUS PACLITAXEL AS SECOND-LINE THERAPY IN PATIENTS WITH METASTATIC OESOPHAGEAL SQUAMOUS CELL CARCINOMA A Multi-centre, Randomized, Non-comparative Phase II Study

acronym: OESIRI

summary:
The aim of our study is to evaluate the efficacy and safety of NALIRI plus 5FU versus paclitaxel as a second-line therapy in patients with locally advanced or metastatic ESCC who had failed to cisplatin- or oxaliplatin-based first-line chemotherapy.

The hypotheses are as follows:

H0: the percentage of patients alive at 9 months of 40% is not useful. H1: the percentage of patients alive at 9 months of 60% is expected.

ReferenceCitation: Randrian V, Adenis A, Desrame J, Barbier E, Di Fiore F, Lievre A, Dahan L, Laurent-Puig P, Mineur L, Breysacher G, Roquin G, Louafi S, Lopez A, Louvet C, Borg C, Metges JP, Faroux R, Gaba L, Manfredi S, Tougeron D. Nal-IRI/LV5-FU versus paclitaxel as second-line therapy in patients with metastatic esophageal squamous cell carcinoma (OESIRI)-PRODIGE 62: A multicentre, randomised, non-comparative phase II study. Dig Liver Dis. 2020 Mar;52(3):347-350. doi: 10.1016/j.dld.2019.11.014. Epub 2019 Dec 30.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
Chu Amiens
Chu Saint Louis
Chu Rouen
Ch Duchenne
Chu de Poitiers
Ch Perpignan
Institut Sainte Catherine
Hopital Européen
Ch Le Raincy


title: Early Versus Differed Arterial Catheterization in Critically Ill Patients With Acute Circulatory Failure: A Multicentre, Open-label, Pragmatic, Randomised, Non-inferiority Controlled Trial (EVERDAC Trial)

acronym: EVERDAC

summary:
The objective of the present research is a combination of a one-sided test of non-inferiority and a one-sided test of superiority. A stepped approach will be used to evaluate these hypotheses:

a less invasive intervention (i.e., no indwelling arterial catheter insertion until felt absolutely needed, according to consensual and predefined safety criteria) is non inferior to usual care (i.e., systematic indwelling arterial catheter insertion in the early hours of shock) in terms of mortality at day 28 (non-inferiority margin of 5%).
a less invasive intervention is not only non-inferior but also superior to usual care in terms of mortality.

Multi-centre, pragmatic, randomised, controlled, open, two-parallel group, non-inferiority clinical trial.

ReferenceCitation: Muller G, Kamel T, Contou D, Ehrmann S, Martin M, Quenot JP, Lacherade JC, Boissier F, Monnier A, Vimeux S, Brunet Houdard S, Tavernier E, Boulain T. Early versus differed arterial catheterisation in critically ill patients with acute circulatory failure: a multicentre, open-label, pragmatic, randomised, non-inferiority controlled trial: the EVERDAC protocol. BMJ Open. 2021 Sep 14;11(9):e044719. doi: 10.1136/bmjopen-2020-044719.

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

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

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital, Tours

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

type_etablissement: CHUR

acronyme: EVERDAC-trial

titre: Insertion systématique précoce d'un cathéter artériel versus insertion différée au cours de l'insuffisance circulatoire aiguë. Essai randomisé pragmatique de non-infériorité, ouvert, multicentrique.

discipline_principale: emergency medicine

nom_porteur: MULLER

prenom_porteur: Grégoire


title: Elderly Cancer PatIents Treated for Advanced or Metastatic Melanoma or NSCLC, Safety and qualiTy of Life Under immunOtheraPies: a Phase IV Trial

summary: The co-primary objectives will be to assess the safety and quality of life under treatment.

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ReferenceCitation: Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, Scher HI, Schrag D. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol. 2006 Nov;7(11):903-9. doi: 10.1016/S1470-2045(06)70910-X.

ReferenceCitation: Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.

ReferenceCitation: Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2.

ReferenceCitation: Brahmer J, Reckamp KL, Baas P, Crino L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Aren Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31.

ReferenceCitation: Cella D, Grunwald V, Nathan P, Doan J, Dastani H, Taylor F, Bennett B, DeRosa M, Berry S, Broglio K, Berghorn E, Motzer RJ. Quality of life in patients with advanced renal cell carcinoma given nivolumab versus everolimus in CheckMate 025: a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):994-1003. doi: 10.1016/S1470-2045(16)30125-5. Epub 2016 Jun 6. Erratum In: Lancet Oncol. 2016 Jul;17 (7):e270.

ReferenceCitation: Champiat S, Dercle L, Ammari S, Massard C, Hollebecque A, Postel-Vinay S, Chaput N, Eggermont A, Marabelle A, Soria JC, Ferte C. Hyperprogressive Disease Is a New Pattern of Progression in Cancer Patients Treated by Anti-PD-1/PD-L1. Clin Cancer Res. 2017 Apr 15;23(8):1920-1928. doi: 10.1158/1078-0432.CCR-16-1741. Epub 2016 Nov 8.

ReferenceCitation: Daste A, Domblides C, Gross-Goupil M, Chakiba C, Quivy A, Cochin V, de Mones E, Larmonier N, Soubeyran P, Ravaud A. Immune checkpoint inhibitors and elderly people: A review. Eur J Cancer. 2017 Sep;82:155-166. doi: 10.1016/j.ejca.2017.05.044. Epub 2017 Jul 6.

ReferenceCitation: Du-Thanh A, Lesage C, Ferreira E, Dereure O, Guillot B. [Innovative therapies for metastatic melanoma in elderly patients]. Ann Dermatol Venereol. 2015 Oct;142(10):549-56. doi: 10.1016/j.annder.2015.03.022. Epub 2015 May 16. French.

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ReferenceCitation: Greenhalgh J. The applications of PROs in clinical practice: what are they, do they work, and why? Qual Life Res. 2009 Feb;18(1):115-23. doi: 10.1007/s11136-008-9430-6. Epub 2008 Dec 23.

ReferenceCitation: Helissey C, Vicier C, Champiat S. The development of immunotherapy in older adults: New treatments, new toxicities? J Geriatr Oncol. 2016 Sep;7(5):325-33. doi: 10.1016/j.jgo.2016.05.007. Epub 2016 Jun 16.

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ReferenceCitation: Khoja L, Day D, Wei-Wu Chen T, Siu LL, Hansen AR. Tumour- and class-specific patterns of immune-related adverse events of immune checkpoint inhibitors: a systematic review. Ann Oncol. 2017 Oct 1;28(10):2377-2385. doi: 10.1093/annonc/mdx286.

ReferenceCitation: Lafage-Pochitaloff M, Costello R, Couez D, Simonetti J, Mannoni P, Mawas C, Olive D. Human CD28 and CTLA-4 Ig superfamily genes are located on chromosome 2 at bands q33-q34. Immunogenetics. 1990;31(3):198-201. doi: 10.1007/BF00211556.

ReferenceCitation: Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030. Epub 2015 May 31. Erratum In: N Engl J Med. 2018 Nov 29;379(22):2185.

repository_institution: Swansea University - Cronfa

repository_institution: University of Zurich - Zurich Open Repository and Archive

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

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sponsor_collaborators:
Institut Paoli-Calmettes
Société Francophone d'Onco-Gériatrie

location_facility: Assistance Publique des Hôpitaux de Marseille

titre: EPITOP-01 : Etude de phase IV visant à évaluer la sécurité et  la qualité de vie lors de traitements par immunothérapie chez le sujet âgé


title: Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode

acronym: BUPRIS

summary: This study aims at investigating if adjunctive buprenorphine at low dose to treatment as usual is effective in reducing severe suicidal ideas in major depressive episode, and at determining the most effective dose.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Ch Perrens
CAPPA Jacques PREVERT
CH Sainte-Anne
CHU Bicêtre
CHU Nîmes
CH Henri Laborit
CHU de Tours
Hospices Civils de Lyon
CHU Grenoble Alpes

region: Occitanie

nom_etablissement: CHU NIMES

acronyme: BUPRIS

titre: Traitement des idées suicidaires sévères durant un épisode dépressif majeur par adjonction de buprénorphine à doses antalgiques.

nom_porteur: Jollant


title: Feasibility and Accuracy of Lymph-node (LN) Restaging by Sentinel LN Procedure and Axillary LN Dissection in Ipsilateral Invasive Breast Cancer Relapse

acronym: FIGARO

summary:
Sentinel lymph node biopsy (SLNB) has become the standard procedure for staging of patients with clinically node-negative breast cancer.

Breast-conserving surgery (BCS) has also been a standard treatment for patients with early breast cancer. However, approximately 10% of patients with BCS develop ipsilateral breast tumor recurrence (IBTR), and mastectomy or resection of the recurrent tumor is generally performed.

There are no specific guidelines available regarding staging and treatment of the regional lymph nodes. However, the reported risk of axillary lymph node metastasis among patients with local recurrence after breast surgery and a previous negative sentinel node biopsy of 26 % is too high to be ignored.

Moreover, evaluation of the regional lymph node basins might be helpful to decide on the indication for adjuvant radiotherapy and systemic treatment. For these reasons it seems sensible to perform a regional lymph node staging procedure in patients with locally recurrent breast cancer.

In general practice, this would mean that patients with recurrent breast cancer and a previous negative sentinel node biopsy would receive an axillary lymph node dissection (ALND) and that patients with a previous ALND would receive no additional axillary staging.

Lymphatic drainage after previous breast surgery and/or radiotherapy would be altered and it remains questionable whether SLNB at the time of surgery for IBTR (second SLNB) is technically feasible and ALND can safely be omitted.

In this study, investigators propose for all patients the realization of SLNB procedure and systematically ALND whatever the results of SLNB analysis, only on patients previously treated with breast conservative surgery.

The aim of this study is to evaluate on a homogeneous prospective multicentric cohort of patients the feasibility and the accuracy of a second SLNB procedure for IBTR.

sponsor_collaborators:
Institut Cancerologie de l'Ouest
Direction Générale de l'Offre de Soins

location_facility: CENTRE REGIONAL DE LUTTE CONTRE LE CANCER D'AUVERGNE - centre JEAN PERRIN

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