title: Neuromuscular Blockade in the Intentive Care Unit, an Observational Study.

acronym: CURATIV

summary:
The study Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis. (Limit: 5000 characters) Neuromuscular blocking agents (NMBAs) are drug capable of inducing a complete paralysis of the muscle. Their use is frequent in the intensive care unit (ICU). Most of the time it is used as a single infusion to facilitate endotracheal intubation, but in the ICU the use of continuous infusion is common in several pathologies: acute distress respiratory syndrome, post-cardiac arrest survivor under hypothermia to prevent shivering, abdominal compartment syndrome, severe traumatic brain injury with uncontrolled intra-cranial pressure and severe asthma among others.

A monitoring of the dose of NMBAs is recommended to guide the depth of paralysis and to guide recovery, but in the ICU, the interest of such a monitoring during continuous infusion is unclear and the level of evidence is low.

The investigators propose to conduct a prospective multicentric observational study to describe the current practice in the use of NMBAs in mechanically ventilated patients in the ICU. As a primary objective we will describe the prevalence of NMBAs use in the ICU. As a secondary objective, the investigators will investigate the impact of protocol and/or monitoring devices of NMBAs on the dose administered and clinical outcome endpoints.

ReferenceCitation: Arroliga A, Frutos-Vivar F, Hall J, Esteban A, Apezteguia C, Soto L, Anzueto A; International Mechanical Ventilation Study Group. Use of sedatives and neuromuscular blockers in a cohort of patients receiving mechanical ventilation. Chest. 2005 Aug;128(2):496-506. doi: 10.1378/chest.128.2.496.

ReferenceCitation: Arroliga AC, Thompson BT, Ancukiewicz M, Gonzales JP, Guntupalli KK, Park PK, Wiedemann HP, Anzueto A; Acute Respiratory Distress Syndrome Network. Use of sedatives, opioids, and neuromuscular blocking agents in patients with acute lung injury and acute respiratory distress syndrome. Crit Care Med. 2008 Apr;36(4):1083-8. doi: 10.1097/CCM.0B013E3181653895.

ReferenceCitation: Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: Queen's University Belfast - Research Portal

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.

ReferenceCitation: Lascarrou JB, Le Gouge A, Dimet J, Lacherade JC, Martin-Lefevre L, Fiancette M, Vinatier I, Lebert C, Bachoumas K, Yehia A, Lagarrigue MH, Colin G, Reignier J. Neuromuscular blockade during therapeutic hypothermia after cardiac arrest: observational study of neurological and infectious outcomes. Resuscitation. 2014 Sep;85(9):1257-62. doi: 10.1016/j.resuscitation.2014.05.017. Epub 2014 Jun 2.

ipd_sharing_description: IPD can be obtained from PI after careful evaluation of request by clinical research committee of the French Intensive Care Society

lead_sponsor: French Society for Intensive Care

location_facility:
CH Le Mans
CH d'Argenteuil
CHD Les Oudairies
CHU Nantes
CHR Orléans
CHU Nimes
CHRU Bretonneau
CHU Kremlin-Bicetre
CHU La Pitié Salpétrière
CH de Versailles
CH de Pontoise


title: Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis

acronym: BEACH

summary: The objective of this study is to evaluate the predictive nature of the biomarker Porphyromonas catoniae measured at the age of 12 months in the occurrence of colonization with Pseudomonas aeruginosa at 36 months of age in children with cystic fibrosis.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
Hôpital Charles Nicolle Rouen
Centre de Perharidy
CHU Grenoble
Hôpital des Enfants Bordeaux
Hôpital Femme-Mère-Enfant Lyon
CHRU de Tours
Hôpital Trousseau
CHRU Rennes
CHRU Angers
CHRU Nantes
Hôpital Necker

intervention_type: Diagnostic Test

lead_sponsor_type: academique

status_simplified: Ongoing


title: Poetry Study - ProGrip™ Self-gripping Polyester Mesh Prospective Embedded REgisTRY for Abdominal Wall Sutureline Reinforcement in Subjects Undergoing Midline Laparotomy to Prevent Incisional Hernia

acronym: POETRY

summary:
Interventional, prospective, multicenter, post-marketing clinical follow-up study.

After midline laparotomy, the probability to develop an incisional hernia ranges from 10% to 50% depending on the complexity of the surgery and patient state of health.

As the clinical data needed for the study corresponds with those collected by Club Hernie registry, the clinical study will use the established registry database to collect performance and safety data on the prevention of incisional hernias within 24 months post operatively.

status: Terminated

study_completion_date_type: Actual

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: Medtronic - MITG

location_facility:
HCL Louis Pradel
CHU de Rennes - Hôpital Pontchaillou
CHU Strasbourg - Nouvel Hôpital Civil
CHU de Nîmes
CHU Besançon
CHU de Bordeaux - Hôpital Haut-Lévêque
CHU Hopitaux de Rouen
CHU Lille
CHU de Nantes
CHU de Bordeaux
Centre Hospitalier Lyon Sud

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


title: Double-blind,Controlled,Randomized Phase 2 Study of Efficacy,Safety,Pharmacokinetics& Pharmacodynamics of Daily Oral Administration of MAP4343 During 6 Weeks in Antidepressant Non-responders Patients Experiencing a Major Depressive Episode

summary: The study is a phase II, double-blind, randomized, placebo controlled, parallel, multicentric study in 110 patients with drug resistant depression.

status: Recruiting

design_allocation: Randomized

enrollment_type: Anticipated

lead_sponsor: Mapreg

sponsor_collaborators:
Mapreg
Eurofins Optimed

location_facility: APHP Hôpital La Pitié Salpétrière - Prinicipal investigator center

intervention_type: Drug


acronym: IMMUNEBOOST

lead_sponsor: UNICANCER

summary: The aim of this research is to study the feasibility of neoadjuvant treatment before chemoradiation in "high risk" HPV-driven Oropharynx cancer

location_facility: Institut de cancerologie de Lorraine Alexis Vautrin

title: A Multicenter, Randomized, Open Label, Phase II Study Evaluating the Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer

type: EudraCT Number

source: euctr

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

appel_a_projets: PHRCK

region: Île-de-France

nom_etablissement: GCS UNICANCER SIEGE

type_etablissement: GCS

titre: IMMUNEBOOST HPV  Etude de phase II, multicentrique, randomisée, en ouvert, d'immunothérapie néo-adjuvante dans les cancers de l'oropharynx HPV induits à haut risque.

discipline_principale: cancer

nom_porteur: MIRGHANI

prenom_porteur: Haitham


title: A Randomized Phase III Trial Assessing a Regorafenib-irinotecan Combination (REGIRI) Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients After Failure of Standard Therapies, According to the A/A Genotype of Cyclin D1

acronym: NEXT-REGIRI

summary: Patients with metastatic colorectal cancer (mCRC) who have received all approved standard treatments (except Regorafenib and TAS 102) no longer have treatment options available while maintaining a good performance status which would allow them to receive a new treatment

ReferenceType: background

ReferenceCitation: Samalin E, Bouche O, Thezenas S, Francois E, Adenis A, Bennouna J, Taieb J, Desseigne F, Seitz JF, Conroy T, Galais MP, Assenat E, Crapez E, Poujol S, Bibeau F, Boissiere F, Laurent-Puig P, Ychou M, Mazard T. Sorafenib and irinotecan (NEXIRI) as second- or later-line treatment for patients with metastatic colorectal cancer and KRAS-mutated tumours: a multicentre Phase I/II trial. Br J Cancer. 2014 Mar 4;110(5):1148-54. doi: 10.1038/bjc.2013.813. Epub 2014 Jan 9.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer

ReferenceCitation: Lu F, Gladden AB, Diehl JA. An alternatively spliced cyclin D1 isoform, cyclin D1b, is a nuclear oncogene. Cancer Res. 2003 Nov 1;63(21):7056-61.

ReferenceCitation: Alt JR, Cleveland JL, Hannink M, Diehl JA. Phosphorylation-dependent regulation of cyclin D1 nuclear export and cyclin D1-dependent cellular transformation. Genes Dev. 2000 Dec 15;14(24):3102-14. doi: 10.1101/gad.854900.

ReferenceCitation: Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, Humblet Y, Bouche O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz HJ, Goldberg RM, Sargent DJ, Cihon F, Cupit L, Wagner A, Laurent D; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):303-12. doi: 10.1016/S0140-6736(12)61900-X. Epub 2012 Nov 22.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ipd_sharing_description: All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all disidentified participants' data, the study protocol, the statistical analysis plan, the clinical study report and the analytic code. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.

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

location_facility:
Hôpital Européen Georges Pompidou
Centre Léon Bérard
CRLC Val d'Aurelle-Paul Lamarque
Centre Antoine Lacassagne
Hôpital Pontchaillou
Hôpital privé Jean Mermoz
Hôpital Saint-Jean
Institut Godinot
Institut Gustave Roussy
Centre François Baclesse
Hôpital Robert Debré


acronym: GUIDE

lead_sponsor: Janssen-Cilag International NV

summary: The purpose of this study is to demonstrate that Super-Responders (SRe; defined as psoriasis participants who receive on-label guselkumab treatment until week 20 and respond with a Psoriasis Area and Severity Index score (PASI) = 0 at weeks 20 and 28) maintain control of disease until week 68 with prolonged treatment intervals of 16 weeks (guselkumab 100 mg every 16 weeks).

ReferenceType: derived

ReferenceCitation: Eyerich K, Weisenseel P, Pinter A, Schakel K, Asadullah K, Wegner S, Munoz-Elias EJ, Bartz H, Taut FJH, Reich K. IL-23 blockade with guselkumab potentially modifies psoriasis pathogenesis: rationale and study protocol of a phase 3b, randomised, double-blind, multicentre study in participants with moderate-to-severe plaque-type psoriasis (GUIDE). BMJ Open. 2021 Sep 13;11(9):e049822. doi: 10.1136/bmjopen-2021-049822.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

location_facility: Universitatsklinikum Schleswig Holstein Kiel

location_facility: Company for Medical Study & Service Selters

location_facility: ISA - Interdisciplinary Study Association GmbH

location_facility: Harzklinikum Dorothea Christiane Erxleben GmbH - Germnay

location_facility: Zentderma BAG Dres. Ostendorf - Bohm - Jo GbR

location_facility: Polyclinique Reims Bezanne - De Courlancy

title: A Phase 3b, Randomized, Double-blind, Parallel Group, Multicenter Study to Evaluate Further Therapeutic Strategies With Guselkumab in Patients With Moderate-to-Severe Plaque-Type Psoriasis

type: Other Identifier

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country: Germany France


title: Aprepitant Versus Hydroxyzine in Association With Cytoreductive Treatments for Patients With Myeloproliferative Neoplasia Suffering From Persistent Aquagenic Pruritus.

acronym: APHYPAP

summary: Phase 3, randomized prospective study, double blind-double placebo, testing oral therapies APREPITANT versus HYDROXYZINE in patients followed for myeloproliferative neoplasms and suffering of persistent aquagenic pruritus.

status: Unknown status

ReferenceCitation: Le Gall-Ianotto C, Verdet R, Nowak E, Le Roux L, Gasse A, Fiedler A, Carlhant-Kowalski D, Marcorelles P, Misery L, Ianotto JC. Rationale and design of the multicentric, double-blind, double-placebo, randomized trial APrepitant versus HYdroxyzine in association with cytoreductive treatments for patients with myeloproliferative neoplasia suffering from Persistent Aquagenic Pruritus. Trial acronym: APHYPAP. Trials. 2021 Dec 19;22(1):938. doi: 10.1186/s13063-021-05864-8.

license: cc-by

license_normalized: cc-by

publisher_dissemination: Springer-Nature

location_facility:
Centre Hospitalier des Pays de Morlaix
Centre Léon Bérard
CHU de Caen
CHRU de Brest - Hôpital Morvan
Hôpital Pontchaillou
Centre Hospitalier de Douarnenez
CHU d'Angers
Hôpital Yves Le Foll
CHU Grenoble Alpes
CHU de Nantes
Centre Hospitalier de Cornouaille

appel_a_projets: PHRCI

region: Bretagne

nom_etablissement: CHRU BREST

type_etablissement: CHUR

acronyme: ApHyPAP

titre: Aprepitant versus Hydroxyzine en association avec les traitements cytoréducteurs pour les patients avec néoplasies myéloprolifératives souffrant d'un Prurit Aquagénique Persistant.

discipline_principale: autre

nom_porteur: IANOTTO

prenom_porteur: Jean-Christophe


title: Multicentric, Open, Randomized Study Comparing Topical Treatment by Patch of Capsaicin to 8% (Qutenza) to Pregabalin Oral in the Early Treatment of Neuropathic Pain After Primary Surgery for Breast Cancer

acronym: CAPTRANE

summary:
Breast cancer is the most common cancer in women in Europe. Therefore, breast cancer has become a chronic disease and patients need to learn to live with it as well as with the adverse effects related to the disease itself or to the therapies used.

As noted in the third "Plan cancer", pain is a major criterion in the quality of life of patients treated for breast cancer.

Neuropathic pain was defined in 2011 by the international Association for the Study of Pain (I.A.S.P.) as the direct result of a lesion or disease affecting the somato-sensory system.

Surgical treatment is often the first treatment of breast cancer. It can be conservative by performing a partial mastectomy (lumpectomy or quadrantectomy) or non-preservative by total mastectomy.

Intercostobrachial neuralgia (NICB) or Post mastectomy painful Syndrome (MPRR) was first described by Wood in 1978 as "chronic pain beginning immediately or early after a mastectomy" Or a lumpectomy affecting the anterior thorax, armpit and/or arm in its upper half. These post-surgical pains are related to a lesion of the nerves in the breast area.

In particular, the intercostobrachial nerve can be severed, stretched or crushed during surgery.

Post-operative neuropathic pain in patients with breast cancer is underdiagnosed either by general practitioner or in a specialized environment.

The diagnosis of neuropathic pain is performed during examination and clinical examination. Several scales allow to detect neuropathic pain but only the DN4 is recognized to be the most specific and sensitive scale.

Patients do not always express this pain. They do not always reconcile with the surgery. Either because the pain occurs a long time after the surgery, or they find it normal to get hurt. These diagnostic difficulties cause a delay in setting up a suitable analgesic treatment.

However, neuropathic pain responds poorly to common analgesics. Diagnosis, evaluation and early management of neuropathic pain are a priority in order to avoid their chronicization, to improve the quality of life of patients with breast cancer and to enable them to return to work quickly.

We therefore assume that the diagnosis of early neuropathic pain at 2 months of surgery associated with initiation of appropriate topical treatment without the systemic effects of conventional oral treatments, would reduce the incidence of Chronic neuropathic pain 6 months after surgery.

status: Completed

primary_purpose: Supportive Care

lead_sponsor: Institut Cancerologie de l'Ouest

sponsor_collaborators:
Institut Cancerologie de l'Ouest
Grünenthal GmbH

location_facility:
Chu Grenoble
Chd Vendee
Institut Jean Godinot
Iuct Oncopole
Centre Leon Berard
Institut Curie
Ch Valenciennes
Centre Oscar Lambret
Hopital Saint Vincent de Paul
Institut de Cancerologie de L'Ouest
CHU NICE

status_simplified: Completed


title: Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vitamin K Antagonists for Acute Deep Vein Thrombosis and Pulmonary Embolism HOKUSAÏ POST VT

summary: Centers that participated in the HOKUSAI VTE trial will be invited to collect follow of previously enrolled patients at least 2 years after the index VTE.

primary_purpose: Other

ReferenceCitation: Bistervels IM, Bavalia R, Beyer-Westendorf J, Ten Cate-Hoek AJ, Schellong SM, Kovacs MJ, Falvo N, Meijer K, Stephan D, Boersma WG, Ten Wolde M, Couturaud F, Verhamme P, Brisot D, Kahn SR, Ghanima W, Montaclair K, Hugman A, Carroll P, Pernod G, Sanchez O, Ferrari E, Roy PM, Sevestre-Pietri MA, Birocchi S, Wik HS, Hutten BA, Coppens M, Naue C, Grosso MA, Shi M, Lin Y, Quere I, Middeldorp S; Hokusai PTS Investigators. Postthrombotic syndrome and quality of life after deep vein thrombosis in patients treated with edoxaban versus warfarin. Res Pract Thromb Haemost. 2022 Jul 1;6(5):e12748. doi: 10.1002/rth2.12748. eCollection 2022 Jul.

ReferenceCitation: Bavalia R, Bistervels IM, Boersma WG, Quere I, Brisot D, Falvo N, Stephan D, Couturaud F, Schellong S, Beyer-Westendorf J, Montaclair K, Ghanima W, Ten Wolde M, Coppens M, Ferrari E, Sanchez O, Carroll P, Roy PM, Kahn SR, Meijer K, Birocchi S, Kovacs MJ, Hugman A, Ten Cate H, Wik H, Pernod G, Sevestre-Pietri MA, Grosso MA, Shi M, Lin Y, Hutten BA, Verhamme P, Middeldorp S; Hokusai post-PE study investigators. Quality of life in patients with pulmonary embolism treated with edoxaban versus warfarin. Res Pract Thromb Haemost. 2021 Jul 14;5(5):e12566. doi: 10.1002/rth2.12566. eCollection 2021 Jul.

lead_sponsor: University Hospital, Montpellier

location_facility:
Clermont-Ferrand University Hospital
Montpellier University Hospital
Le Mans Hospital
Angers University Hospital
Grenoble University Hospital
Brest University Hospital
Strasbourg University Hospital
Amiens University Hospital
APHP Hôpital Européen Georges Pompidou
Nice University Hospital
Dijon University Hospital

intervention_type: Other


title: Validation of the Molecular Diagnosis of Respiratory Viral Infections on the Sputum of Patients With Cystic Fibrosis

acronym: MUCOVIR

summary: The main objective of this project is to evaluate the agreement between nasopharyngeal and sputum specimens in terms of detection of viral infection in Cystic Fibrosis (CF) participants.This is a 12-month national, multicenter prospective study (7 centers). Inclusions concern CF participants (children or adults) with signs of acute respiratory infection seen in consultation or hospitalized in their CF Research Center. A molecular viral multiplex search is performed on both nasopharyngeal and expectoration collected samples for each included participant. Determination of viral detection agreement between the two CF respiratory samples is then performed.

study_type: Observational

time_perspective: Prospective

location_facility:
Hôpital FOCH
CHU de CAEN
CHU de NANTES
CHU Tours
CHU Toulouse CRCM Adulte
CHU de Tours
CHU d'ANGERS
CHRU de Rennes
Centre de PERHARIDY
CHU Toulouse CRCM Pediatrique
AP-HP - Hôpital TROUSSEAU


title: OPTIBOT: Study Describing the Coverage, Cares and the Fertility of Patients of Less Than 45 Years With a Borderline Ovarian Tumor (BOT)

acronym: OPTIBOT

summary:
Retrospective and prospective multi-center study

Indication: Fertility-sparing surgery for patients with borderline ovarian tumor and fertility

Objectives:

Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors, the modalities of care and their fertility.
Validation of a nomogram as an information medium to the patients concerned on their chance of alive birth according to their personal characteristics

Origin and nature of the specific data:

Extraction from the database " Tumeurs Malignes Rares de l'Ovaire " (TMRO)
Collection of retrospective further informations in the participating centers
Data collection from the patients (questionnaires) The data will be identified by the TMRO number allocated to every participant of the TMRO study .

Data traffic :

TMRO database extraction for the patients with BOT and corresponding to the inclusion criteria, supplied by Arcagy-Gineco.

The database will be managed by the coordination team in an anonymous way by means of the patient identifiers of the TMRO base.

Enrichment of the base by the anonymous questionnaires filled by the patients and the complementary data transmissions of the centers on anonymised files.

time_perspective: Other

lead_sponsor: Institut Curie

sponsor_collaborators:
Institut Curie
ARCAGY/ GINECO GROUP

location_facility: Centre Hospitalier Intercommunal Poissy - Saint-Germain

location_facility: Goupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: IUCT Oncopole - Institut Claudius Regaud

location_facility: Institut de Cancérologie de Lorraine - Centre Alexis VAUTRIN


title: Long-term Review of a Cohort of Arthroscopic Bankart Interventions

summary:
Recurrent instability is the most common chronic shoulder pathology of the young and athletic patient. It is a source of functional, sporting and professional disability, and a permanent apprehension to the use of the affected shoulder.

Surgical treatment has been proposed for a long time by the reintegration of the labrum (intervention of Bankart) then by the making of an osteo-muscular stop (intervention of Latarjet).

Like in many domains, surgical techniques have evaluated towards the search for endoscopic alternatives to open surgery, more deleterious.

Bankart's intervention has been performed arthroscopically since the 1980s and remains the majority intervention in the United States. However, its success rate never reached that of open techniques, Bankart and Latarjet. Surgeons therefore sought the predictors of these failures in order to define the limits of the indications for arthroscopic Bankart intervention.

The determination and use of the preoperative instability score (Instability Severity Index Score : ISIS) described by Balg and Boileau is one of the ways to clarify these indications.

The aim of this study is to prospectively establish the values of the ISIS score to obtain an acceptable recurrence rate of long-term instability

ipd_sharing: Undecided

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de RENNES


title: Evaluation of the Long-term Efficacy of the Injection of Botulinum Toxin A Into the Salivary Glands Versus Scopolamine Patches in the Treatment of Drooling in Children Over 4 Years Old With Cerebral Palsy.

acronym: TOXSIALO

summary:
Cerebral palsy is the first cause of motor disability in developed countries. It is associated with altered motor function but also with mental, sensorial and behavior deficiencies. Drooling frequently occurs in children with cerebral palsy (37 to 58%). It causes multiple medical and social complications which can all increase disability and reduce quality of life for the patients and their family. Drooling treatments are various and includes orofacial rehabilitations, anticholinergic medications, botulinum toxin A and B salivary gland injections. Surgeries could also be used, but their benefits are often outweighed by the risk.

Orofacial rehabilitation is firstly recommended, even if few studies evaluated its efficacy.
Medication by Scopoderm®, a cutaneous anticholinergic drug, is frequently used in spite of frequent side effects and a lack of evidence regarding efficacy.
Botulinum toxin salivary gland injections (Botox®) were shown to be effective in reducing the severity of drooling consequences for the patient quality of life up to 12 months after the injections (Reid 2008).

A recent survey carried showed that treatment by Botox® injection would be preferred by professional to Scopoderm® patch, because of better tolerance and efficacy, even if Scopoderm® remained more used by professionals (Chaleat-Valayer 2016). However, a Cochrane review (Walshe 2012) concluded that there is 1) no strong consensus regarding assessment or the timing of all treatments 2) not enough efficacy studies with high level of evidence, 3) mostly efficacy studies vs placebo or no intervention 4) a lack of long term treatment assessment 5) a lack of studies on the patient quality of life.

Our study will be a comparative randomized clinical trial with an active control arm. The hypothesis is that therapeutic treatment of drooling in children with cerebral palsy consisting of a standardized rehabilitation treatment associated with a botulinum toxin A injection (Botox®) in the salivary glands is more effective than the same rehabilitation treatment associated with a treatment by scopolamine patches (Scopoderm®).

The main outcome will be assessed 15 months after initiation of treatment to evaluate long-term effectiveness. Patients from both arms of the trial will received rehabilitation, in order to compare treatment efficacy as it is done in real conditions of treatment. The efficacy of the treatment will be assessed on the impact of the drooling perceived by the patients and their family rather than on the measure of salivary production, as recommended (Walshe 2012).

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre Médico-Chirurgical de Réadaptation des Massues

appel_a_projets: PHRCN

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

acronyme: TOXSIALO-Trial

titre: Evaluation de l'efficacité à long terme de l'injection de toxine botulique A dans les glandes salivaires versus des patchs de scopolamine pour le traitement de la sialorrhée chez les enfants paralysés cérébraux de plus de 4 ans

discipline_principale: médecine physique et réadaptation

nom_porteur: Touzet

prenom_porteur: Sandrine


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.

lead_sponsor: Centre Antoine Lacassagne

collaborators: Centre Hospitalier Universitaire de Caen

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

region: Provence-Alpes-Côte d'Azur

nom_etablissement: CENTRE ANTOINE LACASSAGNE

type_etablissement: CLCC

acronyme: STEREOSARC

titre: Etude de phase II, randomisée évaluant l'immunothérapie après haute dose d'irradiation (SBRT) versus SBRT seule chez les patients porteurs de sarcomes oligométastatiques

nom_porteur: THARIAT

prenom_porteur: Juliette


title: Phase III Study Comparing Neoadjuvant Chemotherapy With Carboplatin and Paclitaxel Followed by Standard Therapy, With Standard Therapy Alone in Women With Cervical Cancer and Para Aortic Positive Lymph Node.

summary:
The main objective of this study is to determine whether neoadjuvant chemotherapy with Carboplatin and paclitaxel plus standard cisplatin-based chemoradiation with extended fields improves overall survival rates compared to standard therapy alone in women with cervical cancer with paraaortic lymph node involvement.

Women in the experimental arm will receive neoadjuvant chemotherapy with carboplatin and paclitaxel every 21 days during 3 cycles followed by standard therapy with extended field external radiation therapy and concomitant chemotherapy. Women in the control arm will receive standard therapy with extended field external radiation therapy and concomitant chemotherapy.

310 patients will be recruited during 4.5 years, with 3 years of follow up period.

ReferenceCitation: Grigsby PW, Heydon K, Mutch DG, Kim RY, Eifel P. Long-term follow-up of RTOG 92-10: cervical cancer with positive para-aortic lymph nodes. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):982-7. doi: 10.1016/s0360-3016(01)01723-0.

ReferenceCitation: Varia MA, Bundy BN, Deppe G, Mannel R, Averette HE, Rose PG, Connelly P. Cervical carcinoma metastatic to para-aortic nodes: extended field radiation therapy with concomitant 5-fluorouracil and cisplatin chemotherapy: a Gynecologic Oncology Group study. Int J Radiat Oncol Biol Phys. 1998 Dec 1;42(5):1015-23. doi: 10.1016/s0360-3016(98)00267-3.

ReferenceCitation: Chantalat E, Vidal F, Leguevaque P, Lepage B, Mathevet P, Deslandres M, Motton S. Cervical cancer with paraaortic involvement: do patients truly benefit from tailored chemoradiation therapy? A retrospective study on 8 French centers. Eur J Obstet Gynecol Reprod Biol. 2015 Oct;193:118-22. doi: 10.1016/j.ejogrb.2015.07.017. Epub 2015 Aug 5.

ReferenceCitation: Duenas-Gonzalez A, Zarba JJ, Patel F, Alcedo JC, Beslija S, Casanova L, Pattaranutaporn P, Hameed S, Blair JM, Barraclough H, Orlando M. Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix. J Clin Oncol. 2011 May 1;29(13):1678-85. doi: 10.1200/JCO.2009.25.9663. Epub 2011 Mar 28.

ReferenceCitation: Singh RB, Chander S, Mohanti BK, Pathy S, Kumar S, Bhatla N, Thulkar S, Vishnubhatla S, Kumar L. Neoadjuvant chemotherapy with weekly paclitaxel and carboplatin followed by chemoradiation in locally advanced cervical carcinoma: a pilot study. Gynecol Oncol. 2013 Apr;129(1):124-8. doi: 10.1016/j.ygyno.2013.01.011. Epub 2013 Jan 24.

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
Institut Claudius Regaud

location_facility: Institut de Cancérologie de l'Ouest - Nantes

region: Occitanie

nom_etablissement: CHU TOULOUSE

type_etablissement: CH

titre: ONCOCOL 01 : Chimiothérapie d'induction suivie d'une radio-chimiothérapie concomitante standard dans les cancers du col utérin avec envahissement ganglionnaire aortique : Essai thérapeutique multicentrique randomisée

nom_porteur: MOTTON

prenom_porteur: Stéphanie


title: Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis

acronym: DenosuMast

summary:
The study is looking at the efficacy of subcutaneously administrated denosumab 60 mg every 6 months versus placebo after 3 years, by analyze of lumbar spine bone mineral density (BMD) in systemic mastocytosis.

Investigators hypothesize that use of denosumab subcutaneously in patients with osteoporosis related to systemic mastocytosis is effective and safe to improve bone mineral density and prevent new bone events, based on targeted specific RANKL secretion by mast cells and short half-life of denosumab.

ReferenceCitation: Johnson MR, Verstovsek S, Jorgensen JL, Manshouri T, Luthra R, Jones DM, Bueso-Ramos CE, Medeiros LJ, Huh YO. Utility of the World Heath Organization classification criteria for the diagnosis of systemic mastocytosis in bone marrow. Mod Pathol. 2009 Jan;22(1):50-7. doi: 10.1038/modpathol.2008.141. Epub 2008 Sep 19.

ReferenceCitation: Theoharides TC, Valent P, Akin C. Mast Cells, Mastocytosis, and Related Disorders. N Engl J Med. 2015 Jul 9;373(2):163-72. doi: 10.1056/NEJMra1409760. No abstract available.

ReferenceCitation: Frenzel L, Hermine O. Mast cells and inflammation. Joint Bone Spine. 2013 Mar;80(2):141-5. doi: 10.1016/j.jbspin.2012.08.013. Epub 2012 Oct 30.

ReferenceCitation: Rabenhorst A, Christopeit B, Leja S, Gerbaulet A, Kleiner S, Forster A, Raap U, Wickenhauser C, Hartmann K. Serum levels of bone cytokines are increased in indolent systemic mastocytosis associated with osteopenia or osteoporosis. J Allergy Clin Immunol. 2013 Nov;132(5):1234-1237.e7. doi: 10.1016/j.jaci.2013.06.019. Epub 2013 Jul 31. No abstract available.

ReferenceCitation: Barete S, Assous N, de Gennes C, Grandpeix C, Feger F, Palmerini F, Dubreuil P, Arock M, Roux C, Launay JM, Fraitag S, Canioni D, Billemont B, Suarez F, Lanternier F, Lortholary O, Hermine O, Frances C. Systemic mastocytosis and bone involvement in a cohort of 75 patients. Ann Rheum Dis. 2010 Oct;69(10):1838-41. doi: 10.1136/ard.2009.124511. Epub 2010 Jun 22.

ReferenceCitation: van der Veer E, Arends S, van der Hoek S, Versluijs JB, de Monchy JGR, Oude Elberink JNG, van Doormaal JJ. Predictors of new fragility fractures after diagnosis of indolent systemic mastocytosis. J Allergy Clin Immunol. 2014 Dec;134(6):1413-1421. doi: 10.1016/j.jaci.2014.05.003. Epub 2014 Jun 27.

ReferenceCitation: Rossini M, Zanotti R, Viapiana O, Tripi G, Idolazzi L, Biondan M, Orsolini G, Bonadonna P, Adami S, Gatti D. Zoledronic acid in osteoporosis secondary to mastocytosis. Am J Med. 2014 Nov;127(11):1127.e1-1127.e4. doi: 10.1016/j.amjmed.2014.06.015. Epub 2014 Jun 20.

ReferenceCitation: Edwards BJ, Bunta AD, Lane J, Odvina C, Rao DS, Raisch DW, McKoy JM, Omar I, Belknap SM, Garg V, Hahr AJ, Samaras AT, Fisher MJ, West DP, Langman CB, Stern PH. Bisphosphonates and nonhealing femoral fractures: analysis of the FDA Adverse Event Reporting System (FAERS) and international safety efforts: a systematic review from the Research on Adverse Drug Events And Reports (RADAR) project. J Bone Joint Surg Am. 2013 Feb 20;95(4):297-307. doi: 10.2106/JBJS.K.01181.

ReferenceCitation: Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C; FREEDOM Trial. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009 Aug 20;361(8):756-65. doi: 10.1056/NEJMoa0809493. Epub 2009 Aug 11. Erratum In: N Engl J Med. 2009 Nov 5;361(19):1914.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
CEREMAST

location_facility: Strasbourg Hospital, Rheumatology department

location_facility: Necker Hospital, Adult haematology department

location_facility: Toulouse Hospital, Dermatology department

location_facility: La Timone Hospital, Dermatology and cutaneous oncology department

location_facility: Caen Hospital, Clinical haematology department

location_facility: Estaing Hospital, Cellular therapy and clinical haematology department

location_facility: Lapeyronie Hospital, Rheumatology and Immunology department

location_facility: La Pitié-Salpêtrière Hospital, Internal medicine and clinical immunology department

location_facility: Cochin Hospital, Rheumatology department

location_facility: Lille CHRU Hospital, Internal medicine and clinical immunology department

location_facility: Jean Minjoz Hospital, Dermatology department

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: DenosuMast

titre: Intérêt de l'utilisation du dénosumab dans l'ostéoporose associée à la mastocytose systémique

discipline_principale: rhumatologie

nom_porteur: FRENZEL

prenom_porteur: Laurent


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.

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.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université d'Artois

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

nom_etablissement: CHRU RENNES

acronyme: POFA

titre: Intérêt de l'anesthésie sans morphiniques (OFA) sur l'incidence des hypoxémies postopératoires chez les patients à risques intermédiaires ou élevés de complications respiratoires postopératoires : étude multicentrique prospective randomisée

discipline_principale: anesthésiologie / réanimation

nom_porteur: BELOEIL

prenom_porteur: Helene


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.

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.

lead_sponsor: Hopital Foch

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

nom_etablissement: HOPITAL FOCH

type_etablissement: EBNL

titre: Thrombectomie mécanique par utilisation combinée d'un stent retriever avec une aspiration distale versus stent retriever seul dans le traitement de l'accident vasculaire cérébral ischémique par occlusion proximale : étude randomisée Aster2

discipline_principale: neurologie

nom_porteur: Lapergue

prenom_porteur: Bertrand


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.

time_perspective: Retrospective

lead_sponsor: Versailles Hospital

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


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.

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

location_facility: Centre hospitalier régional et universitaire de Montpellier

location_facility: Institut regional du Cancer - Val d Aurelle

nom_etablissement: ICM MONTPELLIER

acronyme: LEANOX-LEAn

titre: LEANOX LEAn body mass Normalization of OXaliplatin based chemotherapy for stage III colorectal patients treated in adjuvant setting: Impact on oxaliplatin-induced sensitive neurotoxicity. A Multicenter Phase II Randomized trial

nom_porteur: ASSENAT

prenom_porteur: Eric


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.

lead_sponsor: ARCAGY/ GINECO GROUP

sponsor_collaborators:
ARCAGY/ GINECO GROUP
AstraZeneca

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


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.

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. doi: 10.1136/thx.2004.035220.

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.

location_facility: Centre Hospitalier de Versailles Andre Mignot

acronyme: PALIF

titre: Impact sur la qualité de vie d'une prise en charge palliative systématique dans la fibrose pulmonaire idiopathique , un essai thérapeutique multicentrique.

nom_porteur: DUCHEMANN

prenom_porteur: Boris


acronym: NISCAHN

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.

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

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

ipd_sharing_description: no individual participant data is shared


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

sponsor_collaborators:
Institut Paoli-Calmettes
Janssen-Cilag Ltd.

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


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: Switzerland France

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


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.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repositories:
PubMed Central
irua

repositories_concat: PubMed Central;irua

collaborators: Ecole doctorale de Bretagne en biologie de santé

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


title: Multicentre Double-blind Randomized Clinical Trial Assessing Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy

acronym: CRANIOEXE

summary:
This hypothalamic obesity is associated with serious metabolic and psychosocial consequences.

The purpose of the study is to compare the change of body weight after 6 months treatment with a lifestyle intervention + exenatide compare to the one after the same lifestyle intervention+ placebo in adults patients suffering from a hypothalamic obesity due to treatment of craniopharyngioma.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Européen Georges Pompidou
Hôpital Cochin
CHU de Lyon
CHU de Toulouse
Hôpital Pitié Salpétrière (APHP)
CHU de Brest
CHU d'Angers
CHU de Grenoble
Hôpital Bicêtre
Hôpital Haut-Lévêque
APHM


title: Predictive Tracking of Patient Flow in the Emergency Services During the Virus Winter Epidemics

acronym: PREDAFLU

summary:
Epidemics and infectious diseases in general, punctuate much of the activity of an emergency service. The impact of winter infections is particularly important to vulnerable populations such as infant during bronchiolitis epidemics and the elderly during seasonal influenza. Each year, these epidemic phenomena lead to disorganization of emergency services and healthcare teams by lack of anticipation and organizational measures in particular to manage the approval of emergency services for the most vulnerable populations requiring hospitalization.

For 2 years, the pediatric emergency department of St Etienne University Hospital has a decision support tool for the periods of winter epidemics. Through a retrospective analysis of Passages of Emergency summary, this tool provides an estimate of infants with bronchiolitis flow day to day, and the availability in real time of an abnormally high flow of patients to pediatric emergencies. These data can help to affirm that the epidemic begins in this hospital.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: CHU de Grenoble (adult emergency service)

location_facility: CHU de Saint Etienne (adult emergency service)

location_facility: CHU de Saint Etienne (Pediatric service)

location_facility: CH de Villefranche (adult emergency service)

appel_a_projets: PREPS

nom_etablissement: CHU DE SAINT-ETIENNE

acronyme: PREDAFLU

titre: Suivi prédictif de l'affluence des patients dans les services d'urgences pendant les épidémies virales hivernales

discipline_principale: organisation des soins

nom_porteur: MORY

prenom_porteur: Olivier


title: Randomized Phase II Study Assessing the Efficacy and Safety of 2 Therapeutic Strategies Combining Bevacizumab With Chemotherapy: De-escalation Versus Escalation in Patients With Non-pretreated Unresectable Metastatic Colorectal Cancer

acronym: HIGH-LIGHT

summary:
The intensity of tumour response appears to be correlated with the feasibility and the duration of a therapeutic pause or of a reduced maintenance therapy maintained until progression in patients initially controlled by so-called "induction" chemotherapy. Bevacizumab combined with cytotoxic chemotherapy (5-FU, irinotecan and/or oxaliplatin) has shown that it is possible to improve the tumour response rate and patient prognosis in 1st and 2nd lines. With a very favourable safety profile , it is an excellent candidate as induction treatment and also as maintenance treatment. Prospective data from recent trials have actually demonstrated improvement in PFS and/or overall survival with bevacizumab maintenance alone or in combination with 5FU (or capecitabine) after induction chemotherapy (FOLFIRI or FOLFOX + bevacizumab).

At the same time, the maintenance of anti-angiogenic pressure after progression in 1st line metastatic has demonstrated its benefit in terms of PFS and overall survival. Bevacizumab maintenance in 2nd line metastatic, despite progression, thus appears to be a valid strategy.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Centre Hospitalier de St Malo - Service Hepato-Gastro-Enterologie

location_facility: Hopital Prive Saint Gregoire - Service de Radiotherapie

location_facility: Hopital Pierre Oudot - Service de Gastroenterologie

location_facility: Chu de Saint Etienne-Hopital Nord - Service Hge

location_facility: Ch de Cholet - Service Maladies de L4Appareil Digestif Du Dr Kaasis

location_facility: Chu Robert Debre - Medecine Ambulatoire-Cancerologie


title: Interventional Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury

summary: Mild traumatic brain injury (mTBI) is a very common reason for presentation to pediatric emergency departments. So as not to overlook the risk of complications, which occur at a rate of 0-7%, measures such as cranial computed tomography (CCT-scan) and/or short inpatient observation are prescribed. Ultimately, the majority of these measures could be avoided and a large Australian cohort shows that the risk of brain tumors is 2.44 times higher for children who had a CCT-scan (3.24 for age 1-4 years). Assay of a sensitive biomarker in blood, such as the S100B protein, has the potential to reduce the number of these unnecessary measures.

ReferenceCitation: Bouvier D, Fournier M, Dauphin JB, Amat F, Ughetto S, Labbe A, Sapin V. Serum S100B determination in the management of pediatric mild traumatic brain injury. Clin Chem. 2012 Jul;58(7):1116-22. doi: 10.1373/clinchem.2011.180828. Epub 2012 Apr 23.

ReferenceCitation: The management of minor closed head injury in children. Committee on Quality Improvement, American Academy of Pediatrics. Commission on Clinical Policies and Research, American Academy of Family Physicians. Pediatrics. 1999 Dec;104(6):1407-15.

ReferenceCitation: Bouvier D, Balayssac D, Durif J, Mourgues C, Sarret C, Pereira B, Sapin V. Assessment of the advantage of the serum S100B protein biomonitoring in the management of paediatric mild traumatic brain injury-PROS100B: protocol of a multicentre unblinded stepped wedge cluster randomised trial. BMJ Open. 2019 May 24;9(5):e027365. doi: 10.1136/bmjopen-2018-027365.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

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

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Assistance Publique des Hôpitaux de Marseille

intervention_type: Procedure

nom_etablissement: CHU DE CLERMONT-FERRAND

titre: Evaluation de l'intérêt du dosage de la protéine S100B sérique dans la prise en charge des traumatismes crâniens légers en pédiatrie

discipline_principale: biologie

nom_porteur: BOUVIER

prenom_porteur: Damien


title: Can Nephrocheck™ Predict the Reversibility of Early, Acute Kidney Injury During Septic Shock?

acronym: AKI-CHECK

summary: Patients with septic shock in the intensive care unit have an elevated risk of developing acute kidney injury (AKI).

ReferenceCitation: Titeca-Beauport D, Daubin D, Van Vong L, Belliard G, Bruel C, Alaya S, Chaoui K, Andrieu M, Rouquette-Vincenti I, Godde F, Pascal M, Diouf M, Vinsonneau C, Klouche K, Maizel J. Urine cell cycle arrest biomarkers distinguish poorly between transient and persistent AKI in early septic shock: a prospective, multicenter study. Crit Care. 2020 Jun 1;24(1):280. doi: 10.1186/s13054-020-02984-6. Erratum In: Crit Care. 2020 Aug 4;24(1):483.

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

version: submittedVersion

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CH Dax
CH Marc Jacquet
CHU Montpellier
CH Salon-de-provence
CH de Mont-de-Marsan
CHU Saint-Etienne
CHU Poitiers
CH Cahors
CH Avranches-Granville
CH Paris-Saint Joseph
CHU Amiens


title: Case-control Study of the Influence of Pesticide Exposure on the Occurrence of Hypospadias in Newborns in Picardie

acronym: HYPOMECO

summary: We want to see if there is a relationship between exposure to pesticides and the occurrence of hypospade in Picard newborn .

ReferenceCitation: Haraux E, Tourneux P, Kouakam C, Stephan-Blanchard E, Boudailliez B, Leke A, Klein C, Chardon K. Isolated hypospadias: The impact of prenatal exposure to pesticides, as determined by meconium analysis. Environ Int. 2018 Oct;119:20-25. doi: 10.1016/j.envint.2018.06.002. Epub 2018 Jun 18.

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens

location_facility:
CH Laon
CH Péronne
CH Chateau Thierry
Groupe Santé Victor Pauchet
CH Chauny
CH Compiegne
CH Creil
CH Saint Quentin
CH Abbeville
CH Senlis
CHU Amiens


title: Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms

acronym: ARMEDIC

summary:
The double amputation of the forearms is a rare handicap that seriously impacts the autonomy and the quality of life of patients, social and familial exclusion, and dependence on third parties for everyday activities.

The management of these patients is nearly exclusively through the use of prostheses. Certain patients refuse this solution, or remain penalized by the absence of sensitivity , the lack of precision in movements, and body image issues related to the amputation; the double graft of hands and forearms may, in this circumstance, be the only solution.

Since January 2000, date of the first double hand graft, six bilateral grafts of hands have been performed at the Hospices Civils de Lyon. This first study reported the feasibility of the graft. The functional results obtained after the double transplant have allowed patients to recover complete autonomy for everyday activities, at the price of an immunosuppressive treatment. We have found that these very good functional results are maintained over time and, for a certain number of patients, to return to work which is a factor of social integration.

The rate of medical complications (metabolic, infectious, oncological), essentially related to the immunosuppressive treatment, is not greater to that found for other types of graft, but are considered as a limiting factor for the development of this strategy. These results are confirmed by international experience that is of the same order. Only a few rare cases of re-amputation have been reported in patients for whom the immunosuppressive treatment was discontinued or following vascular thrombosis.

A new study is required to continue this evaluation and to compare double graft to prostheses in terms costs, quality of life, usefulness, satisfaction, autonomy, and social integration. The results of this study will allow the placement of these strategies in the management of patients with double amputation of the hands and forearms.

design_allocation: Non-Randomized

location_facility: Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale

location_facility: Serice de Rééducation et Réadaptation fonctionnelles - Centre l'Espoir

location_facility: Service de Médecine Physique et Réadaptation - Institut Régional de Médecine Physique et de Réadaptation

location_facility: Service de Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon

location_facility: Serice de Rééducation et Réadaptation fonctionnelles - Hôpital Henry-Gabrielle - Hospices Civils de Lyon

location_facility: Serice de Médecine Physique et Réadaptation - Hôpital d'Instruction des Armées Percy

location_facility: Serice de Rééducation et Réadaptation fonctionnelles - Centre Médical de Rééducation Romans Ferrari

location_facility: Service de Médecine Physique et Réadapatation fonctionnelle - Centre de Médecine Physique et de Réadaptation La Tour de Gassies

location_facility: Serice de Médecine Physique et Réadaptation des patients amputés - Centre Médico-Chirugical et de Réadaptation des Massues

location_facility: Serice de Rééducation fonctionnelle - Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape

location_facility: Service de Rééducation et appareillage - Institut Robert Merle d'Aubigné

appel_a_projets: PRME

acronyme: ARMEDIC

titre: Evaluation médico-économique de l'allogreffe bilatérale de mains et avant-bras

discipline_principale: chirurgie plastique et reconstructrice

nom_porteur: Badet

prenom_porteur: Lionel


title: Multicenter Prospective Study Comparing KRAS, NRAS and BRAF Mutation Testing Using OncoBEAM Technique in Plasma vs Conventional Techniques in Formalin Fixed Paraffin Embedded Tissues

acronym: ColoBEAM

summary: RAS genotyping is mandatory for the prescription of anti-EGFR (epidermal growth factor receptor) therapies in patients with metastatic colorectal cancer. The standard genotyping is assessed on formalin-fixed paraffin embedded tumour tissue. This study compares RAS and BRAF genotyping results achieved in analyzing circulating plasma DNA using OncoBEAM™ technique with those achieved using the standard genotyping techniques and formalin-fixed paraffin embedded samples.

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
Institut de Cancérologie de Lorraine
Centre Paul Stauss
CH Auxerre
CHRU Nancy
Polyclinique de Gentilly
CHU Reims-Hôpital Robert Debré
Centre Georges François Leclerc Dijon
CH Chalon Sur Saône-William Morey
Polyclinique Courlancy Reims
CH Besançon-Hopital Jean Minjoz
Hopital Belle-Isle-Metz

intervention_type: Genetic


title: ANRS EP59 CLEAC : Physiopathological Study of Immunovirological Evolution of Perinatally HIV-1 Infected Children Depending on Early (Before 6 Months) or Late (After 2 Years) Antiretroviral Therapy Introduction.

acronym: CLEAC

summary:
The study aims to define and compare the immunological characteristics (lymphocyte subpopulations, specific immunity against HIV, lymphocyte activation, inflammatory parameters) and the virological characteristics (study of viral reservoir) between 2 groups of vertically-HIV-1-infected children, between 5 and 17-year-of-age, who started cART before 6 months-of-age ("early treatment" group) or after 24 months-of-age ("late treatment" group) with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months after the start of cART), whatever the later evolution of the viremia.

Moreover, the viral reservoir will be deeply characterized in 10 children (5 patients in each group) with sustained control of the HIV-1 viremia under cART (≥ 90% of HIV-1 RNA measures <400 copies /mL): quantification of the reservoir in the lymphocyte subpopulations and study of the inductibility of the viral reservoir.

primary_purpose: Basic Science

ReferenceCitation: Frange P, Montange T, Le Chenadec J, Batalie D, Fert I, Dollfus C, Faye A, Blanche S, Chace A, Fourcade C, Hau I, Levine M, Mahlaoui N, Marcou V, Tabone MD, Veber F, Hoctin A, Wack T, Avettand-Fenoel V, Warszawski J, Buseyne F. Impact of Early Versus Late Antiretroviral Treatment Initiation on Naive T Lymphocytes in HIV-1-Infected Children and Adolescents - The-ANRS-EP59-CLEAC Study. Front Immunol. 2021 Apr 22;12:662894. doi: 10.3389/fimmu.2021.662894. eCollection 2021.

oa_host_type: repository

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

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

unpaywall_oa_status: green

publisher_dissemination: Frontiers

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Centre Hospitalier Général- Hôpital Delafontaine


title: Impact on Anti-infectious Treatments of the Early Molecular Detection Technique Coupled With Urinary Test of Infectious Agents Responsible of Community-acquired Pneumonia of Children at Pediatric Emergencies

acronym: OptiPAC

summary:
Community-Acquired Pneumonia (CAP) of children are a recurrent pathology with multiple severity scores. The etiology is never really identified, and the initial treatment is always based on probabilistic antibiotics, in the case of an bacterial infection, and by the way, potentially severe.

Molecular tests ("multiplex") allow the simultaneous detection of a huge number of pathogenic agents, virus and bacteria, are now available.

This project is based on a new strategy of diagnostic, using a multiplex PCR with quick results, coupled to an antigenic urinary test to allow a complete, quick, etiologic diagnostic as soon as children are supported in emergency.

Children are randomized in two groups during inclusions : quick diagnostic strategy versus usual practice. Analyse will be centralized on anti-infectious treatment optimization, with the aim to better treat patients, minimize the costs, and decrease selection pressure of multi-resistant bacteria.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Chu Saint Etienne
Chu Estaing
Chu Grenoble
Chu Marseille
Chu Toulouse
CHU CAEN
Chu Reims
Chu Brest
APHP - Béclère
APHP - Necker
Chu Strasbourg

acronyme: OptiPAC

titre: Impact sur le traitement anti-infectieux probabiliste aux urgences de la détection simultanée par technique moléculaire d'un panel d'agents infectieux (virus et bactéries) responsables des pneumopathies aigües communautaires de l'enfant.

discipline_principale: médecine d'urgence

nom_porteur: CANTAIS

prenom_porteur: Aymeric


acronym: ROSCO-CF

summary:
This is a phase II, dose ranging, multicenter, randomized, double-blind, placebo-controlled study.

The aim of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment "on") separated by a 3 days treatment free period (treatment "off") in adult CF subjects with Cystic Fibrosis carrying 2 Cystic Fibrosis causing mutations with at least one F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa.

This study involved 36 Cystic Fibrosis patients: 24 treated and 12 controls.

sponsor_collaborators:
University Hospital, Brest
ManRos Therapeutics
Cyclacel Pharmaceuticals, Inc.

location_facility: Centre de Ressources et de Compétences de la mucoviscidose

title: A Phase II, Dose Ranging, Multicenter, Double-blind, Placebo Controlled Study to Evaluate Safety and Effects of (R)-Roscovitine in Adults Subjects With Cystic Fibrosis, Carrying 2 Cystic Fibrosis Causing Mutations With at Least One F508del-CFTR Mutation and Chronically Infected With Pseudomonas Aeruginosa, a Study Involving 36 CF Patients (24 Treated, 12 Controls). ROSCO-CF.

acronyme: ROSCO CF

titre: Etude de recherche de dose de phase II, multicentrique, en double aveugle, contrôlée par placebo évaluant la tolérance et l'efficacité de la (R)-roscovitine chez des patients atteints de mucoviscidose, homozygotes F508del-CFTR, infectés chroniquement à Pseudomonas aeruginosa : une étude incluant 36 patients (24 traités, 12 contrôles)

discipline_principale: pneumologie

nom_porteur: RAULT

prenom_porteur: Gilles


acronym: EVA

summary:
Aim : To assess the ability of healthy subjects and patients with a severe motor disability to voluntary control their attention

Material and Methods:

Population: healthy subjects, patients with brain injury Electroencephalographic study to research attentional modulation during different kind of stimulation (visual, auditory, tactile)

Sudy 1: passive recording.

Study 2: active recording (instruction of attentional control given to the subject).

Study 3: active recording with a feedback obtained after a processing of the brain activity.

location_facility: Hospices civils de Lyon, Hôpital Henry Gabrielle,

location_facility: Centre de Recherche en Neurosciences de Lyon


title: Multicentre, Cross-over, PRAgmatic Trial in Atopic Dermatitis Testing Long-term Control Effectiveness of New Phototherapy Regimen During Winter as an add-on Therapy, Coupled With Oral Vitamin D Supplementation vs. Placebo in a Randomised, Parallel-group Trial

acronym: PRADA

summary: Spaced phototherapy sessions during winter as add-on therapy in combination with vitamin D supplementation or not, could be beneficial to improve disease LTC in AD patients

ReferenceCitation: Droitcourt C, Barbarot S, Maruani A, Darrieux L, Misery L, Brenaut E, Adamski H, Chabbert C, Vermersch A, Weiborn M, Seneschal J, Taieb A, Plantin P, Maillard H, Phan A, Skowron F, Viguier M, Staumont-Salle D, Nosbaum A, Soria A, Barbaud A, Oger E, Dupuy A; Groupe de Recherche sur l'Eczema Atopique de la Societe Francaise de Dermatologie (GREAT). A new phototherapy regimen during winter as an add-on therapy, coupled with oral vitamin D supplementation, for the long-term control of atopic dermatitis: study protocol for a multicentre, randomized, crossover, pragmatic trial - the PRADA trial. Trials. 2019 Mar 25;20(1):184. doi: 10.1186/s13063-019-3276-9.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

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

lead_sponsor: Rennes University Hospital

location_facility:
Hôpital Morvan
APHP - Hôpital Tenon
Hôpital Pontchaillou
CHU de Nantes - Hôtel Dieu
Centre Hospitalier
Hôpital Saint André
Hôpital Trousseau
Hôpital Laënnec
CHR St Brieuc

acronyme: PRADA

titre: Essai PRAgmatique randomisé multicentrique en double-aveugle contre placebo dans la Dermatite Atopique, testant le contrôle sur le long terme d'une supplémentation orale en vitamine D en traitement additionnel au traitement standard, couplé à un essai exploratoire sur la photothérapie UV à doses filées pendant la période hivernale

discipline_principale: dermatologie

nom_porteur: DROITCOURT

prenom_porteur: Catherine


acronym: REFRACT

lead_sponsor: University Hospital, Limoges

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.

sponsor_collaborators:
University Hospital, Limoges
Boehringer Ingelheim

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

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


lead_sponsor: Hospices Civils de Lyon

summary:
Renal transplantation represents currently the best therapeutic alternative for end-stage renal failure, not only in terms of patient outcomes (better quality of life and longer survival), but also in terms of costs for the society.

Progress achieved in the last 20 years has resulted in a drastic reduction of the incidence of "classic" (i.e. clinically patent) acute cellular rejection episodes.

Unfortunately, and rather unexpectedly, this progress has had hardly any effect on the frequency of the loss of kidney transplants beyond the first year, as shown by the stagnation of grafts' half lives.

Furthermore, the use of immunosuppressant combinations that are more and more powerful has an impact on adverse effects in recipients, including an increased incidence of infections, cancers, but also metabolic complications (diabetes, osteoporosis, dyslipidemia, etc.), which are cause of significant morbi-mortality.

In an attempt to improve on these disappointing outcomes, some teams have offered to perform screening biopsies: i.e. routine biopsies at specific time points during the follow up, irrespective of graft function. Their primary interest is to allow a pathological analysis of the graft at an early stage, i.e. when potential histological lesions allow for a diagnosis but before these lesions impact on graft's function. Indeed, it has been clearly demonstrated that therapeutic adjustments intended to protect the grafts are most effective when introduced early. There is a fairly broad consensus to perform these biopsies three months and one year after the transplantation. Performing screening biopsies has led to the identification of "subclinical" forms of rejection, i.e. graft infiltration by recipient immune effectors meeting the Banff histological criteria, but without increase in creatininemia.

Assuming that about 10% of screening biopsies performed at 3 months reveal a subclinical rejection, which needs to be treated, the management strategy for the remaining 90% of patients, whose biopsies show either i) a mild inflammatory infiltrates: i.e. "borderline changes", or ii) the complete absence of immune effectors in the graft is, poorly standardized.

The investigators therefore propose to conduct a prospective randomized trial to answer these questions simultaneously by evaluating a strategy to optimize the immunosuppression of renal graft recipients based on the presence or absence of subclinical intragraft inflammatory infiltrates in the screening biopsy performed at 3 months post transplantation. Patients with borderline changes (sub-study A) will be randomized to receive a treatment for rejection (corticosteroid boluses). Patients without inflammation in their graft (sub-study B) will be randomized for corticosteroid withdrawal. Impact on graft function, progression of histological lesions and incidence of morbidity will be evaluated.

location_facility: Institut de Transplantation, Urologie et Néphrologie (ITUN) - CHU de Nantes

location_facility: Service de Néphrologie,Transplantation, Dialyse I - Hôpital Pellegrin - CHU Bordeaux

location_facility: Service de Néphrologie et Transplantation - Hôpital Saint-Louis

location_facility: Département de Néphrologie et Transplantation d'Organes - Hôpital Rangueil - CHU de Toulouse

location_facility: Service de Néphrologie, Transplantation et Immunologie Clinique - Hôpital Edouard Herriot - Hospices Civils de Lyon

location_facility: Service de Néphrologie et Transplantation - Nouvel Hôpital Civil - CHRU Strasbourg

location_facility: Service de Transplantation - Hôpital Universitaire Necker

location_facility: Unité de Transplantation Rénale - Hôpital Pasteur - CHU de Nice

location_facility: Service de Néphrologie, Hémodialyse, Transplantations Rénales - Hôpital de la Cavale Blanche - CHU de Brest

location_facility: Service Urgences Néphrologiques et Transplantation Rénale - Hôpital Tenon

location_facility: Service de Néphrologie - Hôpital Claude Huriez - CHU de Lille

title: Evaluation of a Strategy Based on the 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation: the I4BiS Study

titre: Evaluation d'une stratégie d'optimisation de l'immunosuppression basée sur la biopsie de dépistage des 3 mois en transplantation rénale: étude I4BiS (Infiltrat Inflammatoire Intragreffon Infraclinique et Biopsie de dépiStage)

discipline_principale: néphrologie

nom_porteur: THAUNAT


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: CHRU de Montpellier - Hôpital Saint-Eloi

location_facility: Pôle Cardiovasculaire et Métabolique - Hôpital Larrey


title: Phase II Study Evaluating the Efficacy of the Combination of Metformin to Neoadjuvant Radiochemotherapy in the Treatment of Locally Advanced Rectal Cancer.

summary:
Metformin is an oral antidiabetic of the biguanide class derived from galega officinalis. Historical cohort of patients with diabetes have shown that diabetics on Metformin had a better chance of survival than diabetics not on Metformin. These observations have led to in vitro studies of metformin on cancer cells. It was thus demonstrated that Metformin has anti-proliferative properties.

The aim of our study is to evaluate the efficacy of metformin in combination with neoadjuvant radiochemotherapy in the treatment of locally advanced rectal cancer.

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Léonard de Vinci - SARL du pont Saint Vaast

location_facility: Centre Galilée - Hôpital Privé La Louvière


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

nom_etablissement: CTRE HOSPITALIER UNIVERSITAIRE DE NICE

titre: Validation multicentrique de la sensibilité de la technique FISH pour détecter le réarrangement théranostique ALK dans les cellules tumorales circulantes et prévalence des mutations de résistance thérapeutique pour la prise en charge non-invasive des patients atteints d'un cancer pulmonaire

discipline_principale: oncology

nom_porteur: HOFMAN

prenom_porteur: Paul


title: A Multi-centre, Non-inferiority, Randomized, Double-blind, Phase IV Study Comparing Pristinamycin (2g x 2 Per Day for 2 Days Then 1g x 3 Per Day for 5 to 7 Days) to Amoxicillin (1g x 3 Per Day) for 7 to 9 Days in Adults With Acute Community Acquired Pneumonia With a PORT Score of II or III

summary:
Primary Objective:

To evaluate the clinical efficacy of pristinamycin at a dose of 2g x 2/day for 2 days then 1g x 3/day for 5 to 7 days versus amoxicillin 1g x3 /day for 7 to 9 days, 5 to 9 days after the end of treatment.

Secondary Objectives:

To evaluate the clinical efficacy in a subpopulation bacteriologically documented at inclusion and according to procalcitonin level.

To evaluate the efficacy of treatments against pneumococcus. To evaluate the rate of relapse and mortality 30±2 days after treatment is started.

To document failures. To collect and follow up adverse events.

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

lead_sponsor: Sanofi

location_country: Tunisia France

location_facility:
Investigational Site Number :250023
Investigational Site Number :250034
Investigational Site Number :788005
Investigational Site Number :250015
Investigational Site Number :788002
Investigational Site Number :788007
Investigational Site Number :250054
Investigational Site Number :250010
Investigational Site Number :788014
Investigational Site Number :250022
Investigational Site Number :250031
Investigational Site Number :250029
Investigational Site Number :250004
Investigational Site Number :250001
Investigational Site Number :250032
Investigational Site Number :788001
Investigational Site Number :788009
Investigational Site Number :788011
Investigational Site Number :788004