title: Defining ENDOtypes in Perioperative Hypersensitivity by Extensive Cellular and Molecular PHENotyping and Assessment of Their Association to Severity

acronym: ENDOPHEN

summary:
Perioperative Acute Hypersensitivity (PAH) is a systemic reaction that occurs rapidly following injection of a drug during anesthesia.The HSA-PA reaction must occur within a maximum of one hour after the induction of anesthesia or a new product by the anesthetist. The main mechanism evoked is an immune response of immediate systemic hypersensitivity or anaphylaxis. Anaphylactic reactions are classically described as IgE-dependent and triggered by the injection of allergen which by bridging specific IgE present on the surface of mast cells, induces a massive release of histamine responsible for the observed symptoms. The diagnosis of this mechanism (IgE endotype) requires the determination of associated circulating mediators (histamine and mast cell tryptase) as well as skin tests performed during an allergologic evaluation. However, our previous work on patients with PAH (NASA study, ClinicalTrials.gov: NCT01637220) demonstrated that classical markers of IgE endotype are present in only 42% of patients. This finding has three consequences:

a diagnostic inaccuracy with deleterious consequences for the patient,
the existence of undocumented endotypes explaining the observed clinical manifestations,
a lack of formal identification of culprit drug, with uncertainty about the eviction recommendations leading to consequences for the safety of the patient.

The investigators hypothesize that symptoms associated with PAH are caused by several distinct endotypes involving different cellular effectors and molecular mediators. These endotypes may be related to the immune system but independent of IgE, or independent of the immune system.

To assess these endotypes, The investigators will be measuring the activation status of blood cells and a wide range of secreted mediators in blood drawn as soon as possible after PAH onset, and at steady state during a subsequent allergology visit. These data will be analyzed along with clinical data in multivariate analysis and clustering to define coherent profiles among patients.

Definition of previously unexplored endotypes will allow to explain more PAH reactions and to design new diagnostic and therapeutic strategies.

During the ENDOPHEN protocol, the measurement of a large number of biological parameters will be correlated with the clinical phenotype in patients who have presented a PAH. However, the procedures of general anesthesia themselves lead to a certain number of physiological modifications likely to modify the parameters measured in the ENDOPHEN protocol. This is why it was decided to carry out an ancillary study, the PHENZERO study, the objective of which is to measure the reference values of the parameters provided for in ENDOPHEN in an anesthetized population without any hypersensitivity phenotype ("zero" phenotype).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Européen Georges Pompidou Hospital
Louis Mourier Hospital
La Pitié Salpêtrière Hospital
Ambroise Paré Hospital
Saint Louis Hospital
Beaujon Hospital
Bichat Hospital


title: A Phase II Study of Cetuximab Rechallenge in Combination With Irinotecan in Advanced Metastatic Colorectal Cancer Without KRAS or NRAS or BRAF Mutation (All Wild Type) for Patients Pretreated With FOLFIRI and Cetuximab in First Line With Stopping Cetuximab for Progressive Disease After a Previous Response (Partial Response or Complete Response) and After Treatment With a Fluoropyrimidine, Oxaliplatin Plus Bevacizumab Regimen

acronym: REGAIN

summary:
The main objective of this study is to evaluate the objective response rate at two months (complete disappearance of the disease and partial disappearance of the disease) obtained after administration of combination therapy with cetuximab and irinotecan in the patients with metastatic colorectal cancer.

Secondaries objectives will be assessed progression-free survival, overall survival, toxicity, quality of life.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre de radiothérapie - Clinique Sainte Anne

location_facility: Groupe hospitalier Public du Sud de l'Oise -site de Senlis

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: Therapeutic Nipple Areola Skin-sparing Mastectomy.

summary:
This is a phase III, multicentric, single arm study with a sequential design using the exact conditional Poisson test.

The primary objective of this prospective study is to evaluate whether selected breast carcinoma patients could be treated with nipple sparing mastectomy (NSM) with an acceptable low local recurrence rates.

450 patients will be included over a period of 4 years and will be followed for a 5 years period (twice a year).

All patients must have a complete preoperative evaluation (bilateral mammography, bilateral breast ultrasonography +/- MRI), and a histopathological diagnostic proof of carcinoma (invasive or in situ, all histopathological types, first treatment or relapse).

The study procedure is represented by nipple areola skin-sparing mastectomy followed by immediate breast reconstruction.

After surgery, early and late complications, including specific complications (suffering of the nipple-areolar complexe and suffering of the skin flaps), will be evaluate.

An esthetic evaluation (by patient and clinician) and a quality of life evaluation will be realized throughout the study.

A complementary study, prospective, non-interventional, will be proposed to patients who will benefit from the same surgical technique (NSM) followed by immediate reconstruction, but in the context of preventive surgery (prophylactic surgery for patients mutated or high genetic risk). The aim of this complementary study, which will include a maximum of 60 patients, is to evaluate associated morbidity in prophylactic NSM.

Data will be collected over a 3 months period after surgery.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceType: derived

ReferenceCitation: Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Institut Claudius Regaud

sponsor_collaborators:
Institut Claudius Regaud
Institut Paoli-Calmettes

location_facility: Hôpital Européen Georges Pompidou, Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Etablissement Rennais du Sein - CHP St Grégoire

location_facility: INSTITUT DE CANCEROLOGIE DE L'OUEST - Site René Gauducheau

location_facility: Centre Hospitalier Universitaire de Montpellier

intervention_type: Procedure

status_simplified: Ongoing

appel_a_projets: PHRCK

region: Occitanie

nom_etablissement: INSTITUT CLAUDIUS REGAUD ONCOPOLE

type_etablissement: CLCC

acronyme: MAPAM 01

titre: Mastectomie thérapeutique avec conservation de l'étui cutané et de la Plaque Aréolo-Mamelonnaire

discipline_principale: chirurgie

nom_porteur: JOUVE

prenom_porteur: Eva


acronym: FLIRT

lead_sponsor: The Lymphoma Academic Research Organisation

summary:
Patient will receive either one infusion of rituximab IV and seven administrations of rituximab SC (experimental arm) or four infusions of rituximab IV (standard arm).

The hypothesis is that the use of rituximab by sub cutaneous route and the scheme of administration could:

optimize rituximab exposure leading to improve response rate
increase adaptative response and then improve long-term control disease.

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Hôpital Haut Lévêque - Centre François Magendie

location_facility: Institut de Cancérologie du Gard Hématologie clinique

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau

status: Completed

title: A Randomized Phase III Trial Evaluating Two Strategies of Rituximab Administration for the Treatment of First Line/Low Tumor Burden Follicular Lymphoma (Follicular Lymphoma IV/SC Rituximab Therapy)

source: euctr

design_allocation: Randomized

ipd_sharing: No

status_simplified: Completed


title: Phase III Randomized, Controlled, Open, Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases

acronym: ZOSTER

summary:
Hypo-fractured radiotherapy in stereotactic conditions (RSHF) of bone metastases allows high doses to be delivered to the affected bone segment while sparing adjacent healthy tissues as well as possible. In addition, it not only reduces pain and prevents spinal cord compression, but also improves long-term control of metastatic disease.

Zoledronic acid reduces bone complications. The economic literature shows that stereotactic radiotherapy, like zoledronic acid, are cost-effective strategies in these indications. The objective of this research project is to evaluate the efficiency of adding zoledronic acid to stereotactic radiotherapy in the treatment of vertebral metastases.

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Hopital Lyon Sud
Institut de Cancérologie de Lorraine
Hôpital Privé du Confluent
Centre de Haute Energie
Institut BERGONIE
Stéphane SUPIOT
Centre Henri Becquerel

intervention_type: Combination Product

appel_a_projets: PRME

region: Pays de la Loire

nom_etablissement: INSTITUT DE CANCEROLOGIE DE L'OUEST

acronyme: ZOSTER

titre: Place de l'acide ZOledronique dans la prise en charge par radiothérapie STERéotaxique des métastases vertébrales : une évaluation économique basée sur un essai de phase 3

discipline_principale: economie de la santé

nom_porteur: Supiot

prenom_porteur: Stéphane


title: An Open-label, Single Arm, Multi-centre, Phase II Study Investigating Safety, Tolerability, Efficacy, Pharmacodynamics and Pharmacokinetics of Imlifidase in Patients With Guillain-Barré Syndrome, in Comparison With Matched Control Patients

summary:
The study participants are patients which have been diagnosed with Guillain-Barré Syndrome (GBS) and are planned to receive treatment with intravenous immunoglobulin (IVIg). IVIg is a standard of care treatment for GBS patients. The patients in this study will be treated with the study medicine imlifidase on day 1, and with IVIg on days 3-7.

The purpose of this study is to investigate the safety and effectiveness of imlifidase in patients diagnosed with GBS.

lead_sponsor: Hansa Biopharma AB

location_country:
United Kingdom
Netherlands
France

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: CHU de Montpellier, Hôpital Gui de Chauliac

location_facility: Service de neurologie, Hôpitaux Universitaires de Strasbourg

location_facility: Queen Elizabeth University Hospital Glasgow

location_facility: CHU Bordeaux - Hôpital Pellegrin Tripode

location_facility: CHU Le Kremlin-Bicêtre. Service Neurologie

location_facility: Hôpital de la Timone - Centre de référence des maladies neuromusculaires et de la SLA


acronym: REVOLUMAB

summary:
Immune checkpoint blockade therapies targeting the immunomodulatory effect of cytotoxic T-lymphocyte antigen (CTLA-4) and programmed cell death-1/ Programmed death-ligand 1 (PD-1/PD-L1) have recently demonstrated survival benefit and durable response in phase III trials in several human cancers, especially in tumors that bear high mutation load and/or tumor-associated neoantigen signatures. The aim of these treatments is to restore effector T-cell function and antitumor activity, which could be enhanced in the context of high mutational/neoantigen load. In Isocitrate DeHydrogenase mutated High Grade Gliomas (IDHm HGGs), acquired resistance to alkylating chemotherapy frequently results from the inactivation of mismatch-repair (MMR) proteins which in turn leads to the acquisition of a hypermutator phenotype. These findings suggest that at least in a subset of recurrent IDHm HGGs immune checkpoint blockade therapies may be particularly effective. IDHm HGGs most frequently occur in young adults. The first line treatment consists of maximal safe surgical resection followed by radiotherapy and adjuvant alkylating chemotherapy (Temozolomide or Procarbazine-CCNU-Vincristine regimen (PCV)). Despite these treatments, most IDHm HGGs recurred in few years. There is no standard of care at recurrence and the median overall survival after it is less than 3 years.

The investigators make the hypothesis that treatment with the anti-PD-1 monoclonal antibody Nivolumab will improve 24 weeks progression-free survival in IDHm HGGs that have recurred after initial treatment with radiotherapy and alkylating chemotherapy.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Bristol-Myers Squibb

location_facility: AP-HP - Groupe Hospitalier Pitié-Salpêtrière

location_facility: Hospices Civils de Lyon, Hôpital Pierre Wertheimer

location_facility: IUCT Oncopole - CLCC Institut Claudius Regaud

location_facility: Institut de Cancérologie de l'Ouest (ICO) - site CLCC René Gauducheau

title: A Phase II Study From the POLA National Network of Nivolumab for Recurrent IDH Mutated High-Grade Gliomas

type: EudraCT Number

lead_sponsor_type: academique

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: REVOLUMAB

titre: REVOLUMAB: Etude de phase II utilisant le Nivolumab dans les gliomes de haut-grade sans codélétion 1p19q mais avec mutation IDH en récidive

discipline_principale: cancer

nom_porteur: DEHAIS

prenom_porteur: Caroline


title: A Prospective, Interventional, Baseline Study In Young Male Subjects Aged From 5 to 9 Years

summary: Baseline Study on Duchenne Muscular Dystrophy (DMD) in view to collect data on the natural disease course in a cohort in young male subjects aged from 5 to 9 Years over a period of 6 to 36 months using disease appropriate evaluations.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Genethon

location_country:
United Kingdom
France

location_facility: Great Ormond Street Hospital & University College London Hospital


acronym: COMPLETE

lead_sponsor: H. Lundbeck A/S

summary: The study will evaluate effectiveness of flexible dose vortioxetine 10-20 mg/day on emotional functioning in patients with MDD with an inadequate response to SSRIs/SNRIs.

ReferenceCitation: Christensen MC, Adair M, Loft H, McIntyre RS. The Motivation and Energy Inventory (MEI): Analysis of the clinically relevant response threshold in patients with major depressive disorder and emotional blunting using data from the COMPLETE study. J Affect Disord. 2023 Feb 15;323:547-553. doi: 10.1016/j.jad.2022.11.033. Epub 2022 Nov 14.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

unpaywall_oa_status: hybrid

ReferenceCitation: Christensen MC, Fagiolini A, Florea I, Loft H, Cuomo A, Goodwin GM. Validation of the Oxford Depression Questionnaire: Sensitivity to change, minimal clinically important difference, and response threshold for the assessment of emotional blunting. J Affect Disord. 2021 Nov 1;294:924-931. doi: 10.1016/j.jad.2021.07.099. Epub 2021 Jul 31.

oa_colors: green hybrid

oa_host_type: publisher;repository

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

host_type: repository

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

location_facility: Centro De Salud Mental De Foios (ES0002)

location_facility: PI Mental Health Center of Zirmunai (LT0004)

location_facility: Universita degli Studi di Roma La Sapienza - Azienda Ospedaliera Sant Andrea (IT0013)

location_facility: Hospital Clínico Universiatrio de Salamanca (ES0001)

location_facility: Hospital Universitario Fundacion Alcorcon (ES0009)

location_facility: Jsc Silutes Mental Health And Psychotherapy Center (LT0001)

location_facility: Mental Health Centre Kaunas Outpatient Clinic (LT0005)

location_facility: Dipartimento Salute Mentale ASL Lecce (IT0006)

location_facility: DSM Giulianova c/o ospedale di Giulianova (IT0004)

location_facility: Private Practice Dr. Paule Khalifa (FR0010)

location_facility: Centro De Especialidades A Doblada (ES0006)

location_facility: Dr Karim Boutayeb MD, Office of (FR0009)

location_facility: Instituto Internacional de Neurociencias Aplicadas (ES0004)

location_facility: Antakalnis Psychiatric Consultation Centre (LT0003)

title: Interventional, Open-label, Flexible-dose Study of Vortioxetine on Emotional Functioning in Patients With Major Depressive Disorder With Inadequate Response to SSRI/SNRI Treatment

location_country: Italy Lithuania Spain France

ipd_sharing: Undecided


title: Exploratory Study Evaluating the Interest of PET to 18F-Fludarabine for the Initial Assessment and End-treatment Evaluation of Patients With Symptomatic Multiple Myeloma in the First Line of Treatment, Not Candidates for Marrow Autograft

acronym: Myelofludate

summary: The objective of this exploratory study is to evaluate, for the first time, the sensitivity of 18F-Fludarabine to the initial diagnosis of MM compared to FDG-PET and MRI. The interest of this molecule will also be investigated as part of the end-of-treatment therapeutic evaluation.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Diagnostic

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
Cyceron

location_facility:
CHU de Caen
Centre Eugène Marquis
CHU de Tours
CHU de Brest
CHU d'Angers
CHU de Rennes
CHU de Nantes

appel_a_projets: PHRCI

nom_etablissement: CHU DE NANTES

type_etablissement: CH

acronyme: MyeloFludaPET

titre: Etude exploratoire évaluant l'intérêt de la TEP à la 18F-Fludarabine pour le bilan initial et l'évaluation de fin traitement des patients atteints de myélomes multiples  symptomatiques en première ligne thérapeutique, non candidats à l'autogreffe de moelle

discipline_principale: autre

nom_porteur: BODET-MILIN


title: A European, Multi-centre Phase II Trial of Atezolizumab and Bevacizumab in Patients With Recurrent or Metastatic Squamous-cell Carcinoma of the Head and Neck (HNSCC)

acronym: ATHENA

summary: This proof-of-concept study aims to assess the clinical and biological effects of Atezolizumab combined with Bevacizumab in advanced previously treated squamous-cell carcinoma of the head and neck (HNSCC).

design_allocation: Non-Randomized

lead_sponsor: Centre Leon Berard

location_facility:
Centre Léon Bérard
Clinique Mutualiste de l'Estuaire
Centre Antoine Lacassagne
Institut Claudius Regaud
Centre Paul Strauss
Centre Henri Becquerel
Institut Curie


title: International,Multicenter,Randomized,Open-label, Phase II to Evaluate the Efficacy and Safety of Continuation of Palbociclib+2nd Line Endocrine Therapy in HR+/HER2- ABC Patients Who Had Clinical Benefit During 1st Line Palbociclib.

acronym: PALMIRA

summary: Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)

ipd_sharing: Yes

ipd_sharing_description: Study Leaflet V2_20190115 with study design, primary objetive, inclusion criteria and exclusion criteria

lead_sponsor: MedSIR

sponsor_collaborators: MedSIR Pfizer

location_country:
Germany
Italy
Slovenia
United Kingdom
Spain
France

location_facility: Hospital Regional Universitario de Malaga

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Darent Valley Hospital by Dartford and Gravesham NHS Trust

location_facility: Hospital General Universitari de Valencia

location_facility: Klinikum Mutterhaus der Borromäerinnen Trier

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Policlinico Universitario Campus Bio-medico

location_facility: Abertawe Bro Morgannwg University Local Health Board, Singleton Hospital

location_facility: Univerzitetni klinicni center Maribor Oddelek za onkologijo


acronym: ARION

lead_sponsor: UNICANCER

summary: This study aims to assess the efficacy of durvalumab in combination with radiochemotherapy (FOLFOX and IMRT) and then as maintenance therapy for treating patients with localised unresectable oesophageal cancer. This is a randomized, French national, multicentre, comparative phase II trial

location_facility:
CHU Rangueil Larrey
Centre Paul Strauss, CLCC UNICANCER
Centre Oscar Lambret, CLCC UNICANCER
Iuct, Clcc Unicancer
Hôpital Saint Louis, APHP
Hôpital Haut-Lévêque
Centre Hospitalier Universitaire

title: Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer: a Comparative Randomized Phase II Trial

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.


summary: This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin's lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).

sponsor_collaborators: The Lymphoma Academic Research Organisation

location_facility:
Polyclinique Bordeaux Nord
Centre Léon Bérard
CHU Lyon Sud
Hôpital de la Conception
I.U.C.T Oncopole
CH Perpignan
CHU de Strasbourg
CHU de Dijon - Hôpital le Bocage
CH de Chambéry
CHU de Nantes
CH Victor Dupouy
CHU de Brabois
Institut Paoli Calmette
CH Sud Francilien
Hôpital André Mignot
Hôpital Cochin
CHU Pontchaillou
Clinique Victor Hugo
CHU Montpellier - Saint ELOI
Centre François Baclesse
Hôpital Henri Mondor
Hôpital Saint Louis
CHU Robert Debre
CHU de Limoges
CHU Bretonneau
Hôpital Haut Lévêque
Gustave Roussy Cancer Campus
Hôpital de la Pitié Salpétrière
CHRU Lille - Hôpital Claude Huriez
Centre Henri Becquerel

title: Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II Hodgkin's Lymphoma and FDG-PET Positivity After 2 Cycles of ABVD


title: Retrospective Multicenter Observational Study in NSCLC Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutation Treated First Line by Tyrosine Kinase Inhibitor (TKI)

acronym: EGFR-RETRO

summary: The purpose of our retrospective study is to describe which circumstances EGFR TKI is continued despite progression according to the usual Response Evaluation CrIteria in Solid Tumours (RECIST) in patients with EGFR activating mutations and acquired resistance to EGFR TKI .We will collect their social and demographic data (age, sex), first Progression Free Survival ( PFS) - from start of EGFR TKI to 1st progression PFS 1- and - from first progression according to RECIST to second progression : PFS2- , Overall Survival (OS) - from diagnosis OS 1 and from first progression OS 2 -, mutational status. We will analyze more closely the mode of progression (site), the therapeutic approach at disease progression. We will define two subgroups: those for whom EGFR TKI was continued at least three months despite progression defined according to RECIST criteria, and those for whom a second-line treatment (chemotherapy without EGFR TKI) was chosen at disease progression. It will be individualized the subgroup of patients in whom it was continued TKI after progression.

time_perspective: Retrospective

ReferenceCitation: Auliac JB, Fournier C, Audigier Valette C, Perol M, Bizieux A, Vinas F, Decroisette Phan van Ho C, Bota Ouchlif S, Corre R, Le Garff G, Fournel P, Baize N, Lamy R, Vergnenegre A, Arpin D, Marin B, Chouaid C, Gervais R. Impact of Continuing First-Line EGFR Tyrosine Kinase Inhibitor Therapy Beyond RECIST Disease Progression in Patients with Advanced EGFR-Mutated Non-Small-Cell Lung Cancer (NSCLC): Retrospective GFPC 04-13 Study. Target Oncol. 2016 Apr;11(2):167-74. doi: 10.1007/s11523-015-0387-4.

publisher_dissemination: Springer-Nature

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility:
Site 12
Site 25
Site 19
Centre Hospitalier Les Oudairies
Site 04
Site 06
Site 07
Site 17
Site 18
Site 20
Centre Hospitalier René Dubos
Site 33
Centre Hospitalier du Morvan
Hôpital Yves Le Foll
Site 00
Centre François Baclesse
Site 32
Site 11
Centre Hospitalier Régional
Hospital du Cluzeau
Centre Hospitalier D Argenteuil
Site 14
Site 01
Centre Hospitalier Universitaire


summary: This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice. Patients with HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with Herceptin SC in routine clinical practice use are eligible to participate. The total study duration is anticipated to be 38 months.

lead_sponsor: Hoffmann-La Roche

location_facility: C H Du Pays D'Aix En Provence; Hopital De Jour

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Clinique Claude Bernard; Onco Hematologie

location_facility: Ch Du Mans; Medecine Hematologie Oncologie

location_facility: Polyclinique Francheville; Med Chimiotherapie Radiotherapie

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Centre Catherine de Sienne; Chimiotherapie

location_facility: Ch Pitie Salpetriere; Oncologie Medicale

location_facility: Hopital Antoine Beclere; Hopital De Jour

location_facility: Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie

location_facility: Ch De Montlucon; Hematologie Cancerologie

location_facility: Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie

location_facility: Hopitaux Du Leman Site Thonon; Maternite Gynecologie

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Clinique Tivoli; Chimiotherapie Radiotherapie

location_facility: Clinique Francois 1er; Service De Chimiotherapie

location_facility: Ch De Longjumeau; Hopital De Jour Et Semaine

location_facility: Clinique Medico Chir Charcot; Chir Cancerologie

location_facility: Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: Hopital Henri Mondor; Oncologie Medicale

location_facility: Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire

location_facility: Hopital Louis Pasteur; Oncologie Hematologie

location_facility: Centre Hospitalier De Sens; Medecine Generale Oncologie

location_facility: Clinique De La Sauvegarde; Chimiotherapie

location_facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale

location_facility: Hopital Clinique Claude Bernard; Oncologie Medicale

location_facility: Polyclinique Du Languedoc; Chimiotherapie

location_facility: CH Annecy Genevois site Annecy; Oncologie

location_facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

location_facility: Clinique Saint Jean Languedoc; Oncologie Medicale

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Hopital De Falconaja Furiani; Hopital De Jour

location_facility: Ch Francois Mitterrand; Medecine Oncologie

location_facility: Groupe Hospitalier Public Du Sud De L'Oise GHPSO; Oncologie

location_facility: Centre Mistral; Chirurgie Cancerologie Gynecologiques

location_facility: Chi Emile Durkheim Site Epinal; Oncologie

location_facility: Ghi Le Raincy Montfermeil; Oncologie Medicale

location_facility: Ctre Hosp Prive Beauregard; Hop De Jour Chimiotherapie

location_facility: Cmc De Tronquieres;Chimiotherapie Et Radiotherapie

location_facility: Clinique Armoricaine Radiologie; Cons Externes

location_facility: Ch Georges Renon; Oncologie Radiotherapie

location_facility: Clinique Saint Faron; Sce Oncologie Radiotherapie

location_facility: Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie

location_facility: Centre De Radiotherapie Et D'Oncologie; Oncologie

location_facility: Medipole De Savoie; Departement Oncologie

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: Chi De Cornouaille; Oncologie Hospitalisation

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: CH Carcassonne; Service Onco Hematologie

location_facility: CH de Saint Jean De Maurienne; Had St Jean De Maurienne

location_facility: Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie

location_facility: Clinique De L Estree; Oncologie Medicale

location_facility: CH de Marne la vallee; Oncologie Medicale


title: Medical and Economic Evaluation of an External Beam Radiotherapy Combined With a Brachytherapy Boost Compared With an Exclusive External Beam Radiotherapy for Intermediate-risk Prostate Cancer

summary:
The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment.

The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.

status: Unknown status

lead_sponsor: Hospices Civils de Lyon

location_facility: Institut de Cancerologie de Lorraine Alexis Vautrin

location_facility: Centre d'oncologie et de radiothérapie Mâcon

location_facility: Centre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon Berard

intervention_type: Radiation


acronym: ERIBRAIN

lead_sponsor: Institut Paoli-Calmettes

summary: To evaluate the efficacy of eribulin for treatment of HER2-negative breast cancer brain metastases (BCBM)

ReferenceType: background

ReferenceCitation: Arslan C, Dizdar O, Altundag K. Chemotherapy and biological treatment options in breast cancer patients with brain metastasis: an update. Expert Opin Pharmacother. 2014 Aug;15(12):1643-58. doi: 10.1517/14656566.2014.929664.

ReferenceCitation: Bart J, Nagengast WB, Coppes RP, Wegman TD, van der Graaf WT, Groen HJ, Vaalburg W, de Vries EG, Hendrikse NH. Irradiation of rat brain reduces P-glycoprotein expression and function. Br J Cancer. 2007 Aug 6;97(3):322-6. doi: 10.1038/sj.bjc.6603864. Epub 2007 Jul 3.

ReferenceCitation: Bartsch R, Fromm S, Rudas M, Wenzel C, Harbauer S, Roessler K, Kitz K, Steger GG, Weitmann HD, Poetter R, Zielinski CC, Dieckmann K. Intensified local treatment and systemic therapy significantly increase survival in patients with brain metastases from advanced breast cancer - a retrospective analysis. Radiother Oncol. 2006 Sep;80(3):313-7. doi: 10.1016/j.radonc.2006.08.001. Epub 2006 Sep 7.

ReferenceCitation: Chang AY, Ying XX. Brain Metastases from Breast Cancer and Response to Treatment with Eribulin: A Case Series. Breast Cancer (Auckl). 2015 May 24;9:19-24. doi: 10.4137/BCBCR.S21176. eCollection 2015.

ReferenceCitation: Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Dieras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. doi: 10.1016/S0140-6736(11)60070-6. Epub 2011 Mar 2.

ReferenceCitation: Jimeno A. Eribulin: rediscovering tubulin as an anticancer target. Clin Cancer Res. 2009 Jun 15;15(12):3903-5. doi: 10.1158/1078-0432.CCR-09-1023. Epub 2009 Jun 9.

ReferenceCitation: Joly F, Lange M, Rigal O, Correia H, Giffard B, Beaumont JL, Clisant S, Wagner L. French version of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) version 3. Support Care Cancer. 2012 Dec;20(12):3297-305. doi: 10.1007/s00520-012-1439-2. Epub 2012 May 2.

ReferenceCitation: Jordan MA, Kamath K, Manna T, Okouneva T, Miller HP, Davis C, Littlefield BA, Wilson L. The primary antimitotic mechanism of action of the synthetic halichondrin E7389 is suppression of microtubule growth. Mol Cancer Ther. 2005 Jul;4(7):1086-95. doi: 10.1158/1535-7163.MCT-04-0345.

ReferenceCitation: Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2015 Feb 20;33(6):594-601. doi: 10.1200/JCO.2013.52.4892. Epub 2015 Jan 20.

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Lin NU, Lee EQ, Aoyama H, Barani IJ, Barboriak DP, Baumert BG, Bendszus M, Brown PD, Camidge DR, Chang SM, Dancey J, de Vries EG, Gaspar LE, Harris GJ, Hodi FS, Kalkanis SN, Linskey ME, Macdonald DR, Margolin K, Mehta MP, Schiff D, Soffietti R, Suh JH, van den Bent MJ, Vogelbaum MA, Wen PY; Response Assessment in Neuro-Oncology (RANO) group. Response assessment criteria for brain metastases: proposal from the RANO group. Lancet Oncol. 2015 Jun;16(6):e270-8. doi: 10.1016/S1470-2045(15)70057-4. Epub 2015 May 27.

ReferenceCitation: Lu J, Steeg PS, Price JE, Krishnamurthy S, Mani SA, Reuben J, Cristofanilli M, Dontu G, Bidaut L, Valero V, Hortobagyi GN, Yu D. Breast cancer metastasis: challenges and opportunities. Cancer Res. 2009 Jun 15;69(12):4951-3. doi: 10.1158/0008-5472.CAN-09-0099. Epub 2009 May 26. No abstract available.

ReferenceCitation: Matsuoka H, Tsurutani J, Tanizaki J, Iwasa T, Komoike Y, Koyama A, Nakagawa K. Regression of brain metastases from breast cancer with eribulin: a case report. BMC Res Notes. 2013 Dec 18;6:541. doi: 10.1186/1756-0500-6-541.

ReferenceCitation: Narayan S, Carlson EM, Cheng H, Condon K, Du H, Eckley S, Hu Y, Jiang Y, Kumar V, Lewis BM, Saxton P, Schuck E, Seletsky BM, Tendyke K, Zhang H, Zheng W, Littlefield BA, Towle MJ, Yu MJ. Novel second generation analogs of eribulin. Part III: Blood-brain barrier permeability and in vivo activity in a brain tumor model. Bioorg Med Chem Lett. 2011 Mar 15;21(6):1639-43. doi: 10.1016/j.bmcl.2011.01.096. Epub 2011 Jan 26.

ReferenceCitation: Pivot X, Marme F, Koenigsberg R, Guo M, Berrak E, Wolfer A. Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy. Ann Oncol. 2016 Aug;27(8):1525-31. doi: 10.1093/annonc/mdw203. Epub 2016 May 13.

ReferenceCitation: Qin DX, Zheng R, Tang J, Li JX, Hu YH. Influence of radiation on the blood-brain barrier and optimum time of chemotherapy. Int J Radiat Oncol Biol Phys. 1990 Dec;19(6):1507-10. doi: 10.1016/0360-3016(90)90364-p.

ReferenceCitation: Schwartz LH, Litiere S, de Vries E, Ford R, Gwyther S, Mandrekar S, Shankar L, Bogaerts J, Chen A, Dancey J, Hayes W, Hodi FS, Hoekstra OS, Huang EP, Lin N, Liu Y, Therasse P, Wolchok JD, Seymour L. RECIST 1.1-Update and clarification: From the RECIST committee. Eur J Cancer. 2016 Jul;62:132-7. doi: 10.1016/j.ejca.2016.03.081. Epub 2016 May 14.

ReferenceCitation: Thavarajah N, Bedard G, Zhang L, Cella D, Beaumont JL, Tsao M, Barnes E, Danjoux C, Sahgal A, Soliman H, Chow E. Psychometric validation of the functional assessment of cancer therapy--brain (FACT-Br) for assessing quality of life in patients with brain metastases. Support Care Cancer. 2014 Apr;22(4):1017-28. doi: 10.1007/s00520-013-2060-8. Epub 2013 Nov 28.

ReferenceCitation: Toth K, Vaughan MM, Peress NS, Slocum HK, Rustum YM. MDR1 P-glycoprotein is expressed by endothelial cells of newly formed capillaries in human gliomas but is not expressed in the neovasculature of other primary tumors. Am J Pathol. 1996 Sep;149(3):853-8.

ReferenceCitation: Zhang RD, Price JE, Fujimaki T, Bucana CD, Fidler IJ. Differential permeability of the blood-brain barrier in experimental brain metastases produced by human neoplasms implanted into nude mice. Am J Pathol. 1992 Nov;141(5):1115-24.

sponsor_collaborators:
Institut Paoli-Calmettes
Eisai Inc.

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

status: Withdrawn

title: A Phase II Study of Eribulin in Brain Metastases From HER2-negative Breast Cancer Pre-treated With Anthracyclines and Taxanes


type: Other Identifier

title: Diagnostic Yield of Post PRandial Esophageal High Resolution Impedance Manometry in Patients With Gastro-Esophageal Reflux Disease Symptoms Resistant to Proton Pump Inhibitor Therapy

acronym: PRIMER

summary:
Gastro-esophageal reflux disease (GERD) is defined as the reflux of gastric content into the esophagus that causes troublesome symptoms or complications. Nine to 30% of the population suffers from GERD-suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). In the absence of warning signs, proton pump inhibitors (PPI) are prescribed as first-line treatment. However, 20 to 60% of patients are unsatisfied because of persistent symptoms when taking PPI. Causes of persistent symptoms are: erroneous diagnosis of GERD (up to 50% of PPI non-responders), rumination syndrome, excessive weakly acid reflux on PPI due to defective esophago-gastric junction or an excessive number of transient lower esophageal sphincter relaxations (main mechanism of GERD), poor acid secretion inhibition on PPI, and non-compliance to therapy. Complementary examinations are indicated to explain persistent GERD symptoms. Upper gastro-intestinal endoscopy is performed first to rule out an esophageal tumor and to identify erosive esophagitis, a specific sign of GERD. However, it is normal in up to 70% of symptomatic GERD patients. Direct detection of reflux episodes is then requested to confirm GERD. The gold standard for reflux detection is the ambulatory measurement of esophageal pH for 24 to 96 hours using a catheter (catheter-based pH-monitoring) or a capsule clipped into the esophagus (wireless pH-monitoring). Reflux episodes are defined as an esophageal pH < 4. Another method of reflux detection is based on liquid and gas detection in the esophagus using pH-impedance monitoring. Recently the combination of impedance and esophageal pressure monitoring, called esophageal high resolution impedance manometry (HRIM) was introduced to simultaneously identify reflux episodes and their mechanisms. It has several advantages over esophageal pH measurement: shorter recording duration (1 or 2 hours post prandial) and identification of reflux mechanisms that might guide the choice of the best therapeutic option.

Hypothesis: The 1-hour post prandial esophageal HRIM might be useful to diagnose GERD.

location_facility: Service d'Hepato-Gastroenterologie - Hôpital Trousseau - CHU de Tours

location_facility: Service de Physiologie Digestive, Respiratoire, Urinaire et Sportive - CHU de Rouen

location_facility: Service d'Hepato-Gastroenterologie - Hôpital Haut Lévêque - CHU de Bordeaux

location_facility: Service d'Hepato-Gastroenterologie - Hôtel Dieu - CHU de Nantes

location_facility: Service d'Hepato-Gastroenterologie - Hôpital Pontchaillou- CHU de Rennes

location_facility: Service d'Explorations Fonctionnelles Digestives - Hôpital Edouard Herriot - HCL

location_facility: Service d'Hepato-Gastroenterologie - Hôpital Louis Mourier - APHP

appel_a_projets: PHRCN

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

acronyme: PRIMER

titre: Performance diagnostique la manométrie-impédance sophagienne post prandiale pour le diagnostic de reflux gastro-sophagien chez les patients présentant des symptômes de reflux résistants au traitement par inhibiteurs de la pompe à protons

discipline_principale: explorations fonctionnelles

nom_porteur: Roman

prenom_porteur: Sabine


title: A GCO Trial Exploring the Efficacy and Safety of Nivolumab Monotherapy or Nivolumab Plus Ipilimumab in Pre-treated Patients With Advanced, Refractory Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Tumors (NECs)

acronym: NIPINEC

summary:
Neuroendocrine tumors of the lung include the small cell carcinoma (SCLC), and large cell neuroendocrine carcinoma (LCNEC) and represent 20% of lung cancer. One of the only studies reported to date is reporting on a progression-free survival (PFS) and overall survival (OS) of 5.2 months and 7.7 months, respectively.

Poorly differentiated gastroentero-pancreatic neuroendocrine carcinomas (GEP-NEC) represent a small sub-group of digestive NENs, according to the studies, 7 to 21% of patients. However, their prognosis is more negative, with the 5-year survival at less than 20%.

Many Phase III trials showed superiority in terms of efficacy and tolerance of nivolumab+/-ipilimumab versus standard chemotherapy in second-line treatment in metastatic solid tumors. Neuroendocrine tumors are considered as rare disease without therapeutic guidelines in this setting. The French academic oncology groups (IFCT, FFCD and GERCOR) have the opportunity to recruit a sufficient number of patients, in a reasonable period of time, to provide a proof-of-concept of the safety and efficacy of nivolumab+/-ipilimumab in this population.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

collaborators: Federation Francophone de Cancerologie Digestive

collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Paris - Curie
Centre Hospitalier du Pays d'Aix
Lyon - Hôpital Edouard Herriot
CHU d'Angers
Avignon - CH
CHU d'Amiens-Picardie
Auxerre - CH


title: A Phase 1b/2 Study to Evaluate the Safety and Efficacy of APR-246 in Combination With Azacitidine for the Treatment of Mutation TP53 (TP53) Mutant Myeloid Neoplasms

summary: The main purpose of this study is to determine the safe and efficacy of APR-246 in combination with azacitidine as well as to see complete remission of this patients

ReferenceCitation: Cluzeau T, Sebert M, Rahme R, Cuzzubbo S, Lehmann-Che J, Madelaine I, Peterlin P, Beve B, Attalah H, Chermat F, Miekoutima E, Rauzy OB, Recher C, Stamatoullas A, Willems L, Raffoux E, Berthon C, Quesnel B, Loschi M, Carpentier AF, Sallman DA, Komrokji R, Walter-Petrich A, Chevret S, Ades L, Fenaux P. Eprenetapopt Plus Azacitidine in TP53-Mutated Myelodysplastic Syndromes and Acute Myeloid Leukemia: A Phase II Study by the Groupe Francophone des Myelodysplasies (GFM). J Clin Oncol. 2021 May 10;39(14):1575-1583. doi: 10.1200/JCO.20.02342. Epub 2021 Feb 18.

repositories_concat: PubMed Central

lead_sponsor: Groupe Francophone des Myelodysplasies

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Aprea Therapeutics

location_facility: Dr Pierre Peterlin and Pr Patrice Chevalier

location_facility: Hôpital Saint Louis - Hématologie Séniors


title: A Randomized Phase III Study of Decitabine (DAC) With or Without Hydroxyurea (HY) Versus HY in Patients With Advanced Proliferative Chronic Myelomonocytic Leukemia (CMML)

acronym: GFM-DAC-CMML

summary:
This is a phase III, two-arm, randomized, stratified, multicenter, open-label study with individual therapeutic benefit aim:

Decitabine (DAC) with or without Hydroxyurea (HY) versus HY in patients with advanced proliferative Chronic Myelomonocytic Leukemia (CMML)

The primary objective of the study is to compare between the two arms Event-free Survival (EFS).

Secondary objectives are to compare between both arms:

Overall Survival (OS) Cumulative incidence of AML Overall and Complete Response Rates at 3 and 6 cycles according to IWG 2006 criteria modified for CMML Response duration Toxicity (hematological and non hematological) Prognostic factors

ReferenceCitation: Pleyer L, Leisch M, Kourakli A, Padron E, Maciejewski JP, Xicoy Cirici B, Kaivers J, Ungerstedt J, Heibl S, Patiou P, Hunter AM, Mora E, Geissler K, Dimou M, Jimenez Lorenzo MJ, Melchardt T, Egle A, Viniou AN, Patel BJ, Arnan M, Valent P, Roubakis C, Bernal Del Castillo T, Galanopoulos A, Calabuig Munoz M, Bonadies N, Medina de Almeida A, Cermak J, Jerez A, Montoro MJ, Cortes A, Avendano Pita A, Lopez Andrade B, Hellstroem-Lindberg E, Germing U, Sekeres MA, List AF, Symeonidis A, Sanz GF, Larcher-Senn J, Greil R. Outcomes of patients with chronic myelomonocytic leukaemia treated with non-curative therapies: a retrospective cohort study. Lancet Haematol. 2021 Feb;8(2):e135-e148. doi: 10.1016/S2352-3026(20)30374-4.

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Janssen-Cilag Ltd.

location_facility: IUCT Oncopole - Département d'hématologie


acronym: ECULISHU

lead_sponsor: University Hospital, Toulouse

summary:
The investigators aim to perform the first controlled randomized prospective study using ECZ in pediatric STEC-HUS. This is of great interest as there is still no efficient specific therapy in that potentially devastating disease.

Furthermore, published data concerning the use of ECZ in STEC-HUS are controversial, reflecting statistical bias in retrospective or uncontrolled studies, thus emphasizing the need for prospective studies.

ReferenceCitation: Groussolles M, Winer N, Sentilhes L, Biquart F, Massoud M, Vivanti AJ, Bouchghoul H, Rozenberg P, Olivier P, Desbriere R, Chauleur C, Perrotin F, Coatleven F, Fuchs F, Bretelle F, Tsatsaris V, Salomon LJ, Sananes N, Kayem G, Houflin-Debarge V, Schmitz T, Benoist G, Arnaud C, Ehlinger V, Vayssiere C; Groupe de Recherche en Gynecologie Obstetrique. Arabin pessary to prevent adverse perinatal outcomes in twin pregnancies with a short cervix: a multicenter randomized controlled trial (PESSARONE). Am J Obstet Gynecol. 2022 Aug;227(2):271.e1-271.e13. doi: 10.1016/j.ajog.2022.01.038. Epub 2022 Feb 3.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

ReferenceCitation: Imdad A, Mackoff SP, Urciuoli DM, Syed T, Tanner-Smith EE, Huang D, Gomez-Duarte OG. Interventions for preventing diarrhoea-associated haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Jul 5;7(7):CD012997. doi: 10.1002/14651858.CD012997.pub2.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Matrat L, Bacchetta J, Ranchin B, Tanne C, Sellier-Leclerc AL. Pediatric atypical hemolytic-uremic syndrome due to auto-antibodies against factor H: is there an interest to combine eculizumab and mycophenolate mofetil? Pediatr Nephrol. 2021 Jun;36(6):1647-1650. doi: 10.1007/s00467-021-05025-8. Epub 2021 Mar 28.

ReferenceCitation: Muff-Luett M, Sanderson KR, Engen RM, Zahr RS, Wenderfer SE, Tran CL, Sharma S, Cai Y, Ingraham S, Winnicki E, Weaver DJ, Hunley TE, Kiessling SG, Seamon M, Woroniecki R, Miyashita Y, Xiao N, Omoloja AA, Kizilbash SJ, Mansuri A, Kallash M, Yu Y, Sherman AK, Srivastava T, Nester CM. Eculizumab exposure in children and young adults: indications, practice patterns, and outcomes-a Pediatric Nephrology Research Consortium study. Pediatr Nephrol. 2021 Aug;36(8):2349-2360. doi: 10.1007/s00467-021-04965-5. Epub 2021 Mar 10.

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repositories_concat: PubMed Central;xg94hz585

location_facility:
Clocheville Hospital
Morvan Hospital
La Timone Hospital
Robert Debré Hospital
Purpan Children Hospital
Trousseau Hospital
Mother and Child Hospital
Anne de Bretagne University Hospital
Jeanne de Flandre Hospital
Pellegrin Hospital
Women, Mother and Child Hospital
Necker Hospital
University Hospital

title: Early Treatment With the Monoclonal C5 Antibody Eculizumab in Pediatric Patients Affected by Shiga-toxin Related Hemolytic and Uremic Syndrome: A Phase III Prospective Randomized Controlled Therapeutic Trial Versus Placebo

type: Other Grant/Funding Number

nom_etablissement: CHU TOULOUSE

acronyme: ECULISHU

titre: Traitement précoce par l'anticorps monoclonal anti C5 eculizumab de patients pédiatriques atteints d'un syndrome hémolytique et urémique à Escherichia Coli sécréteurs de Shiga-toxine: essai clinique de phase III prospectif contrôlé randomisé contre placebo

discipline_principale: néphrologie

nom_porteur: GARNIER

prenom_porteur: Arnaud


title: Etude du Dosage Des d-dimères sériques Pour le Diagnostic d'Exclusion Des Thrombi Intra-atriaux Avant Ablation Endocavitaire de Fibrillation Atriale

summary: The purpose of this study is to determine whether D-dimer dosage allow to exclude risk of intraatrial thrombus before performing an ablation of atrial fibrillation

ReferenceType: result

ReferenceCitation: Milhem A, Ingrand P, Treguer F, Cesari O, Da Costa A, Pavin D, Rivat P, Badenco N, Abbey S, Zannad N, Winum PF, Mansourati J, Maury P, Bader H, Savoure A, Sacher F, Andronache M, Allix-Beguec C, De Chillou C, Anselme F; ATE Study Group. Exclusion of Intra-Atrial Thrombus Diagnosis Using D-Dimer Assay Before Catheter Ablation of Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Feb;5(2):223-230. doi: 10.1016/j.jacep.2018.09.009. Epub 2018 Nov 1.

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

location_facility: Service de cardiologie, Clinique Saint Gatien

location_facility: Service de cardiologie, CHI Aix Pertuis CHPA-CHIAP

location_facility: Service de cardiologie, CHU Clermont Ferrand

location_facility: Service de cardiologie, APM Hôpital de La Timone

location_facility: Service de cardiologie, Centre Cardiologique du Nord

location_facility: Service de cardiologie, Polyclinique Vauban

location_facility: Service de cardiologie, Institut Mutualiste Montsouris

location_facility: Service de cardiologie, Institut Jacques Cartier

location_facility: Service de cardiologie, CH de la Région d'Annecy

location_facility: Service de cardiologie, CHU Saint Etienne

location_facility: Service de cardiologie, CHU Toulouse Hôtel Dieu St Jacques

location_facility: Service de cardiologie, AP Hôpital la Pitié Salpêtrière

location_facility: Service de cardiologie, Nouvelles Cliniques Nantaises

location_facility: Service de cardiologie, Clinique Saint Joseph

location_facility: Service de cardiologie, HCL Groupement Est

location_facility: Service de cardiologie, AP Hôpital Henri Mondor

location_facility: Service de cardiologie, Hôpital Saint Joseph

location_facility: Service de cardiologie, CHR Metz Thionville

location_facility: Service de cardiologie, CHI Le Raincy Montfermeil

location_facility: Service de cardiologie, Groupe Hospitalier Bichat Claude Bernard

location_facility: Service de cardiologie, HP Les Franciscaines

intervention_type: Other


title: Utility of Sodium Lactate Infusion During Septic Shock: Pilot Study

summary: ULIS-1 is an open-label pilot study concerning utility of molar sodium lactate in fluid balance in septic shock patients

lead_sponsor: University Hospital, Lille

location_facility:
Ch Dunkerque
CH LENS
Chu Rouen
CH DOUAI
Hôpital Roger Salengro, CHU
CH ARRAS
Hopital Victor Provo - Roubaix


title: Value of the Combination Ultrasonography With Ti-RADS Score / Dual Tracer Scintigraphy MIBI-Tc99m/Iodine-123 in the Detection of Malignancy of Thyroid Nodules (Sup or Egal to 15 mm) Classified Bethesda III or IV on Cytology

acronym: MIBI-THYR

summary: The main objective of the study is to show that the addition of ultrasonography to the dual tracer scintigraphy MIBI-Tc99m/Iodine-123 will increase (at least +5%) the negative predictive value compared to the dual tracer scintigraphy alone in detection of malignancy in thyroid nodules ≥15 mm classified as Bethesda III-IV on cytology.

location_facility: Assistance publique des Hôpitaux de Paris

location_facility: Centre Hospitalier et Universitaire (chu)

acronyme: MIBI-THYR

titre: MIBI-THYR : Intérêt du couple scintigraphie double traceur MIBI-Tc99m/Iode-123 et échographie avec score TIRADS dans la détection de malignité des nodules thyroïdiens (= 15mm) classés Bethesda III ou IV en cytoponction.

nom_porteur: MIRALLIE

prenom_porteur: Eric


title: Early Echographic Asystole as a Predictive Factor of Absence of Spontaneous Circulatory Activity Recovery (SCAR) in Prehospital Cardio Respiratory Arrests (CRA) - ACE Study

acronym: ACE

summary:
Assessment of prognostic performances of CCU in CRA Recovery (CRAR) has already been explored but 1) Only in intra-hospital medicine, 2) in very variable timings. ACE Research focuses on the extra-hospital window and predictive value of Early CCU (within 12 minutes of rescucitation initiation) with ambitious endpoints : curable etiologies identification, early anticipation of ECMO procedures, early anticipation of organ donation process, and evaluation of intrinsic contribution criterion to resuscitation interruption.

The primary objective of ACE study is to investigate the positive predictive value (PPV) of early ultrasound asystole on the absence of CRAR. The secondary objectives are multiple and innovative despite an observational design: impact on the morbi-mortality of the target population (frequency of curable etiologies, pre-therapeutic and therapeutic delays, morbidity...), delay of ECMO implementation of an ECMO (Extracorporeal Membrane Oxygenation), failure rate of organ donation due to overdelays, construction of a multifactorial score associated with CRAR.

ReferenceCitation: Javaudin F, Pes P, Montassier E, Legrand A, Ordureau A, Volteau C, Arnaudet I, Le Conte P. Early point-of-care focused echocardiographic asystole as a predictive factor for absence of return of spontaneous circulatory in out-of-hospital cardiac arrests: a study protocol for a prospective, multicentre observational study. BMJ Open. 2019 Aug 30;9(8):e027448. doi: 10.1136/bmjopen-2018-027448.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

location_facility:
CH Saint-Nazaire
Ch Chateaubriant
Chru Brest
Chu Angers
Nantes University Hospital
Chd Vendee
Chru Tours


title: Oral Evaluation by the Nurses From the Office of Access to Healthcare ("PASS") for Vulnerable People as a Vector for the Detection of Oral Diseases to Improve Access to the Appropriate Healthcare Branch - PASSDENT Study

acronym: PASSDENT

summary:
Oral health is defined as the state of being free from dental or periodontal diseases and discomfort of oral cavity. WHO considers that oral hygiene is a major public health problem whatever the countries (developed, developing, and underdeveloped).

The two main local medical problems are dental caries and periodontal diseases. Without appropriate treatments, both diseases can lead to local functional and esthetic damages, and can also have some negative repercussions on health.

Studies showed that there are great social disparities among people concerned by oral health issues. People in vulnerable situations (homeless and low incomes people, refugees) had less recourse to dental care. Those who consult do it less often and later. Reasons are mainly cost related, but also people in vulnerable situation don't perceive dental care as an important matter and don't know where and how to ask for help for having dental care.

PASS (french acronym for "Office of Access to Healthcare") departments, setting in both private and public health institutions, are intended to facilitate the access to care and the support of people in vulnerable situations, and their accompaniment in the steps necessary for the recognition of their rights.

Nurses of the Annecy PASS department had developed a questionnaire called "healthplan guide" that aim at helping them to screen and identify people with dental diseases among those in vulnerable situation, and to sensitize them about the importance of oral hygiene and how to improve it. This questionnaire is use in daily practice.

This study hypothesizes that more patients will be sensitized to benefit a dental examination in a dental practice if nurses use the "healthplan guide" questionnaire combined with an oral and dental evaluation.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Annecy Genevois

location_facility: Centre d'hébergement et de réinsertion sociale Saint-François


title: A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors

acronym: REGOMUNE

summary:
Assessment of the efficacy and safety of Regorafenib and Avelumab in patients with advanced or metastatic solid tumors (ten cohorts), once the Recommanded Phase II Dose (RP2D) has been determined (phase I trial).

Assessement of the efficacy and safety of a low-dose of regorafenib (80mg/day) with avelumab in patients with advanced or metastatic colorectal tumors.

ReferenceCitation: Cousin S, Cantarel C, Guegan JP, Mazard T, Gomez-Roca C, Metges JP, Bellera C, Adenis A, Korakis I, Poureau PG, Bourcier K, Toulmonde M, Kind M, Rey C, Auzanneau C, Bessede A, Soubeyran I, Italiano A. Regorafenib-avelumab combination in patients with biliary tract cancer (REGOMUNE): a single-arm, open-label, phase II trial. Eur J Cancer. 2022 Feb;162:161-169. doi: 10.1016/j.ejca.2021.11.012. Epub 2022 Jan 5.

ReferenceCitation: Toulmonde M, Brahmi M, Giraud A, Chakiba C, Bessede A, Kind M, Toulza E, Pulido M, Albert S, Guegan JP, Cousin S, Mathoulin-Pelissier S, Perret R, Croce S, Blay JY, Ray-Coquard I, Floquet A, Italiano A. Trabectedin plus Durvalumab in Patients with Advanced Pretreated Soft Tissue Sarcoma and Ovarian Carcinoma (TRAMUNE): An Open-Label, Multicenter Phase Ib Study. Clin Cancer Res. 2022 May 2;28(9):1765-1772. doi: 10.1158/1078-0432.CCR-21-2258.

oa_colors: green other

evidence: open (via free pdf)

evidence: oa repository (via page says license)

publisher_dissemination: American Association for Cancer Research

sponsor_collaborators:
Institut Bergonié
Bayer
Merck KGaA, Darmstadt, Germany

location_facility: Centre Hospitalier Régional Universitaire - CHU Morvan

location_facility: IUCT Oncopôle - Institut Claudius Regaud


acronym: ROAD

lead_sponsor: Alfasigma S.p.A.

summary:
Colonic microbiota changes may play a key role in the pathogenesis of acute diverticulitis. A previous proof-of-concept study suggests that rifaximin, a low-absorbable oral antibiotic, may be beneficial for prevention of acute diverticulitis recurrence by modulating the gut microflora.

The main objective of this study is to evaluate the safety and efficacy of two different doses of a delayed release formulation of rifaximin, versus placebo, for the prevention of recurrence of acute diverticulitis and diverticular complications in patients with a recent episode of acute diverticulitis.

location_facility: Ospedale Cardinal Massaia SOC Gastroenterologia ed Endoscopia Digestiva

location_facility: AOU Seconda Università degli Studi di Napoli Unità Operativa Complessa di Epato-Gastroenterologia

location_facility: Ospedale Valduce Unità Operativa Complessa di Gastroenterologia

location_facility: AOU di Bologna - Policlinico S.Orsola Malpighi - Dipartimento di Scienze Mediche e Chirurgiche

location_facility: Ospedale S. Salvatore di L'Aquila Unità Operativa di Gastroenterologia, Epatologia e Nutrizione

location_facility: AOU di Padova Unità Operativa Complessa di Gastroenterologia

location_facility: Centre Hospitalier Universitaire (CHU) de Strasbourg Service de Chirurgie Digestive et Endocrinienne

location_facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

location_facility: Ospedale Popoli Unità Operativa Semplice Dipartimentale Chirurgia Endoscopica

location_facility: Hôpital Avicenne Service Gastro-entérologie

location_facility: Hospital Costa del Sol Servicio Digestivo

location_facility: Fondazione IRCCS Policlinico San Matteo Dipartimento di Medicina Interna

location_facility: Ospedale Sant'Anna Unità Operativa di Medicina Interna

location_facility: Ospedale Cristo Re - Divisione di Medicina Interna e Gastroenterologia

location_facility: Ospedale Ciaccio - De Lellis Divisione di Gastroenterologia ed Endoscopia Digestiva

location_facility: Fondazione Policlinico Universitario A. Gemelli Unità Operativa Complessa di Gastroenterologia e Malattie del Fegato

location_facility: Hospital Vall d'Hebrón Servicio de Aparato Digestivo

location_facility: Centre Hospitalier Regional Universitaire Claude Huriez Service de Chirurgie Digestive et Générale

location_facility: Hospital General San Jorge de Huesca Servicio de Aparato Digestivo

location_facility: Ospedale "San Paolo" - Unità Operativa Complessa di Gastroenterologia ed Endoscopia Digestiva

location_facility: Policlinico Universitario Campus Biomedico Unità Operativa Complessa di Gastroenterologia ed Endoscopia Digestiva

location_facility: Istituto Clinico Humanitas-Unità Operativa Malattie Infiammatorie Croniche Intestinali

location_facility: Hôpital Charles Nicolle - CHU Rouen Service Hépato-Gastroentérologie

location_facility: Policlinico Federico II - UOSD Diagnosi Fisiopatologica e Terapia delle Malattie Motorie Digestive

location_facility: PO Cisanello - AOU Pisana Unità Operativa Complessa di Gastroenterologia - AOUP Gastroenterologia Universitaria

location_facility: Ospedale Civile S. Agostino Estense - Divisione di Endoscopia Digestiva

location_facility: Policlinico Federico II - UO di Epatogastroenterologia ed endoscopia digestiva

location_facility: AOU Cagliari - Policlinico Monserrato Gastroenterologia

location_facility: Ospedale San Gerardo Endoscopia Digestiva

location_facility: Hospital Clínico Universitario Lozano Blesa Servicio de Aparato Digestivo

location_facility: Policlinico Ss Annunziata - ASL 2 Lanciano Vasto Chieti UOSD Endoscopia Digestiva

location_facility: IRCCS Policlinico San Donato Unità Operativa Medicina Generale III, Gastroenterologia

location_facility: Ospedale Sant'Andrea - Gastroenterologia

location_facility: Università degli Studi di Bari Policlinico Medicina Interna

location_facility: Ente Ospedaliero Ospedali Galliera Chirurgia Generale

location_facility: Hospital Universitario de Belltvitge Servicio de Cirugía General y Digestiva

location_facility: Hospital General Universitario de Alicante Servicio de Aparato Digestivo

location_facility: Yeovil District Hospital NHS Trust Department of Surgery

location_facility: Ospedale Policlinico S.Martino Istituto di Ricovero e Cura per l'Oncologia Dipartimento di Medicina Interna e Specialità Mediche U.O. Clinica Gastroenterologica

location_facility: Ospedale Buccheri La Ferla Fetebenefratelli Unità Operativa di Gastroenterologia e Endoscopia Digestiva

location_facility: Hospital Clínic Servicio de Gastroenterología

location_facility: Hôpital Saint-Joseph Service Hépato-Gastroentérologie

location_facility: Azienda Ospedaliera Universitaria Integrata - UOC Gastroenterologia A- Borgo Trento-Dipartimento Medicina Generale

location_facility: Hospital Universitario de Canarias Servicio de Gastroenterología

location_facility: Ospedale Civile San Giovanni di Dio - Divisione di Gastroenterologia ed Endoscopia Digestiva

location_facility: UNIMI - San Paolo (ASST Santi Paolo e Carlo) Medicina Generale

location_facility: Azienda Ospedaliera San Giovanni Addolorata Gastroenterologia ed Endoscopia Digestiva

location_facility: Centre Médic Teknon Servicio de Aparato Digestivo

location_facility: Azienda Ospedaliera San Giovanni Battista Molinette - S.C. Gastroenterologia e Epatologia

location_facility: Azienda Ospedaliera Policlinico Consorziale di Bari Dipartimento di Gastroenterologia

location_facility: Azienda Ospedaliera Garibaldi Unità Operativa Complessa di Gastroenterologia

location_facility: AOU OO. RR. San Giovanni di Dio e Ruggi d'Aragona - Dipartimento di Medicina e Chirurgia - Gastroenterologia

location_facility: Hospital de Ourense Servicio de Aparato Digestivo

location_facility: CHU Nantes, Hôtel Dieu Clinique de Chirurgie digestive et endocrinienne (CCDE) Institut des maladies de l'Appareil Digestif (IMAD)

location_facility: Ospedale di Circolo e Fondazione Macchi Endoscopia

title: Rifaximin Delayed Release (400 mg Tablet) for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications. A Phase II, Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial

location_country:
Germany
Italy
United Kingdom
Netherlands
Spain
France


title: Longitudinal Study of Brain Amyloid imaGing in MEMENTO

acronym: MEMENTOAmyGing

summary: A Multicenter national longitudinal cohort study including at least 800 individuals consecutively recruited from French Research Memory Centers and followed-up over 24 month and included in Memento.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Fondation Plan Alzheimer
GE Healthcare
Avid Radiopharmaceuticals

location_facility: CHU de Bordeaux - Hôpital Xavier-Arnozan

location_facility: CHU de Saint-Etienne - Hôpital de la charité


title: A Phase II, Multicenter, Open Label Study Evaluating the Efficacy and the Tolerance of Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia (MTSA)

acronym: MTSA

summary: This study aims at evaluating the safety and the tolerance of the micro-transplantation in elderly patients with acute myeloid leukemia who are ineligible to conventional allogeneic transplantation.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de Nancy


title: Non Interventional Study Dealing With the Use of Trabectedin (Yondelis®)-Pegylated Liposomal Doxorubicin (Caelyx®) in Patient With Platinum-sensitive Relapse

summary: The French cooperative group GINECO proposes to implement an observational study to describe a real situation, in daily practice tolerance and methods of administration of trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®, in ovarian platinum sensitive cancer relapse.

ReferenceCitation: Selle F, Heudel PE, Hardy-Bessard AC, Pozet A, Meunier J, Gladieff L, Lotz JP, Provansal M, Augereau P, Berton D, Bonichon-Lamichhane N, Orfeuvre H, Pautier P, Kalbacher E, Tazi Y, Spaeth D. GINECO Prospective Non-interventional PROSPECTYON Study: Trabectedin Plus Pegylated Liposomal Doxorubicin for Platinum-sensitive Recurrent Ovarian Cancer. Anticancer Res. 2020 Jul;40(7):3939-3945. doi: 10.21873/anticanres.14385.

unpaywall_oa_status: bronze

publisher_dissemination: Anticancer Research USA Inc.

lead_sponsor: ARCAGY/ GINECO GROUP

sponsor_collaborators:
ARCAGY/ GINECO GROUP
PharmaMar

location_facility: Hôpital Morvan - Centre Hospitalier Universitaire

location_facility: Hôpital Privé Drôme Ardèche - Clinique Pasteur

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: Cabinet d'Oncologie - Hôpital Privé Sainte Marie

location_facility: Centre de Radiothérapie - Clinique Sainte-Anne

location_facility: Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie


acronym: ECHANGE

summary:
Prenancy and specialy delivery for hemophilia mother and her children possibly hemophilia is risked.

Diagnostical of hemophilia pregnan is the first difficulty but patients with hemorrhagic menstruation without etiology known, hemorrhagic complication during a chirurgical procedure or during previously pregnancy currently are examine in Haemostasis consultation.

None French recommendation specifie for health practice of these hemophilia patients exists. However, Anglo-Saxon recommendations are published in 2011.

The objective of this study is to realize a French investigation of health practice about hemophilia care of these patients and to compare them with the English reference table.

ReferenceCitation: Nau A, Gillet B, Guillet B, Beurrier P, Ardillon L, Cussac V, Guillou S, Raj L, Trossaert M, Horvais V, Bayart S, Potin J, Rose J, Macchi L, Couturaud F, Lacut K, Pan-Petesch B. Bleeding complications during pregnancy and delivery in haemophilia carriers and their neonates in Western France: An observational study. Haemophilia. 2020 Nov;26(6):1046-1055. doi: 10.1111/hae.14117. Epub 2020 Aug 25.

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

repository_normalized: HAL

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

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

repositories_concat: HAL

lead_sponsor: University Hospital, Brest

location_facility:
CHRU de Brest
CHU de Poitiers
CHU de TOURS
CHU d'Angers
CHU de Rennes
CHU de Nantes
Ch Le Mans


title: Ventilation's Parameters Applied in Emergency Medicine. Observational Study

acronym: PARAVENT

summary:
To prospectively assess the mechanical ventilation management when its provided by Emergency Physicians in French Hospital, and to assess complications and outcome of these patients.

The study could be measure the proportion of patients developing an Acute Respiratory Failure Distress after a take care of by French Emergency Departments.

lead_sponsor: Poitiers University Hospital

location_facility:
Marjanovic Nicolas
Pierre-Arnaud Fort
CH de Niort
Paul Fievet
Pierre-Marie Noël
CHU de Bordeaux
Thomas Lenormand

acronyme: PARAVENT

titre: Protocole paramédical de ventilation au cours du Syndrome de Détresse Respiratoire Aigüe : essai prospectif, multicentrique, randomisé, contrôlé, en ouvert, de phase III, en grappes avec permutation séquentielle

nom_porteur: CARTEAUX

prenom_porteur: Guillaume


title: Dependence on Analgesics in Chronic Non-cancer Pain: Comparison of the Perceptions of the Algologist Physician and the Perception of the Patient.

acronym: DISCORDANCE

summary: The identification of an addiction to opioid analgesics has become strong recommendation for the purpose of improving the clinical management of the patients. However, the success of the patient's clinical management, in terms of analgesia and treatment of drug dependence, rests on the acceptance of this management by the patient himself. The main objective of this study is to evaluate the factors associated to the discrepancy between the assessment of dependence on analgesic drugs by the algologist and the perception that the patient with non-cancer chronic pain has of this dependence.

location_facility:
University Hospital Clermont-Ferrand
University Hospital Nice
University Hospital Limoges
University Hospital Montpellier
University Hospital Bordeaux
University HospitalToulouse
University Hospital Marseille

intervention_type: Behavioral


title: Platelet Transfusion Efficacy in Critically Ill Patients

acronym: RE-CCIP

summary:
Between 10 and 15% of critically ill patients require platelet transfusion within their intensive care unit (ICU).

Platelets (PLT) are given to prevent bleeding in thrombocytopenic patients or to treat bleeding as part of massive transfusion or in bleeding thrombocytopenic patients.

International and local guidelines (American Association of Blood Banks-AABB) are mainly based on experts' opinion. The efficacy of PLT transfusion in the ICU setting remains poorly studied and unknown and the administration of PLT may be associated with adverse effects including an increased risk of hospital acquired infection. Finally, the short PLT shelve-life may be responsible for inventory issues. Altogether, this makes very important to improve the evidence that support PLT transfusion in ICU patients.

This is a multicentre prospective observational study that aims to first determine PLT transfusion efficacy and to identify the parameters associated with transfusion efficacy and to analyse the compliance with international (and local) guidelines of PLT transfusion in ICU patients.

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
CHRU de Brest
CH des Pays de Morlaix
CHU de Tours
Chba Site de Vannes
CHU d'Angers
CHU de Rennes
CHU de Nantes


lead_sponsor: UNICANCER

summary: Open label multicentric randomized phase II trial, using high throughput genome analysis as a therapeutic decision tool, aimed at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with a standard treatment (pemetrexed in Non-squamous patients and erlotinib in squamous cells, targeted substudy 1) as well as immunotherapy with maintenance therapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).

ReferenceCitation: Middleton G, Crack LR, Popat S, Swanton C, Hollingsworth SJ, Buller R, Walker I, Carr TH, Wherton D, Billingham LJ. The National Lung Matrix Trial: translating the biology of stratification in advanced non-small-cell lung cancer. Ann Oncol. 2015 Dec;26(12):2464-9. doi: 10.1093/annonc/mdv394. Epub 2015 Sep 25.

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repository_institution: Imperial College London - Spiral

repository_institution: University of Illinois at Chicago - INDIGO

sponsor_collaborators: Intergroupe Francophone de Cancerologie Thoracique

location_facility: CHU Clermont Ferrand - Hôpital Gabriel Montpied

location_facility: Hospices Civils de Lyon- Hôpital Louis Pradel

location_facility: Centre Hopsitalier Intercommunal de Créteil

location_facility: Centre Hospitalier Universitaire de Besancon - Hopital Jean Minjoz

title: Intergroup Trial UNICANCER UC 0105-1305/ IFCT 1301: SAFIR02_Lung - Evaluation of the Efficacy of High Throughput Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Non-small Cell Lung Cancer


title: Multicenter Phase II Study Evaluating the Efficacy of Radiotherapy With Modulation Intensity and Integrated Boost (SIB-IMRT) at the Dose of 80Gy, Associated With Chemotherapy by Temozolomide in the Treatment of Adult Glioblastomas

acronym: Glio-SIB-Up

summary:
Glioblastoma (GBM) is the most aggressive and most frequent brain tumour. Approximately four people per 100,000 inhabitants are diagnosed with this disease every year. The standard treatment comprises surgical resection (whenever possible), normofractionated radiotherapy at a dose of 60Gray (Gy) and temozolomide (TMZ). Median overall survival in these patients is 14.6 months [13.2-16.8].

In a previous phase I clinical trial, dose escalation tolerance using simultaneous-integrated boost intensity-modulated radiation therapy (SIB-IMRT) technic has been evaluated. The investigator demonstrated that SIB-IMRT until a dose of 80Gy in 32 daily fractions, associated with TMZ is feasible and well tolerated by patients with glioblastoma.

The aim of this present phase II clinical trial is to evaluate the overall survival at 18 months for patients with glioblastoma receiving TMZ, according to standard protocol, associated to radiotherapy delivered at 80Gy using SIB-IMRT technic. The first planning target volume (PTV), including oedema and tumour highlighted on T2 flair magnetic resonance imaging (MRI) sequences, will receive 60.8Gy in 32 daily fractions. The second PTV, including tumour highlighted on T1 MRI sequences, will receive 80.0Gy in 32 daily fractions.

Secondary objectives are tolerance, survival free progression and quality of live evaluations.

Sixty seven patients will be enrolled in this present trial.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
Centre de cancérologie des dentellières
Centre d'oncologie et de radiothérapie
CHU Besançon
Institut de cancérologie de Lorraine
Paul Strauss
Centre Georges François Leclerc
CHU Amiens Picardie

intervention_type: Device

region: Bourgogne-Franche-Comté

nom_etablissement: CLCC GEORGES-FRANCOIS LECLERC

acronyme: GLIO-SIB-UP

titre: Etude de phase II multicentrique évaluant l'efficacité d'une radiothérapie avec modulation d'intensité et Boost intégré (SIB-IMRT) à la dose de 80Gy, associée à une chimiothérapie par Témozolomide dans le traitement des Glioblastomes de l'adulte

nom_porteur: TRUC

prenom_porteur: Gilles


title: Comparison of Two Strategies for Blood Pressure Control in the Setting of Acute Ischemic Stroke to Reduce Cerebral Hemorrhage After Thrombectomy: Systolic Blood Pressure Target of Less Than 130 mmHg vs Less Than 185 mmHg, for 24 Hours Following Reperfusion, in Patients With Cerebral Infarction Due to Occlusion of the Anterior Circulation

acronym: BP-TARGET

summary: A randomized, multicenter study comparing two strategies: 1 / standard management of systolic blood pressure according to international recommendations (systolic blood pressure <185 mm Hg) versus 2 / intensive blood pressure management Systolic with a target <130 mm Hg.

ReferenceCitation: Maier B, Brauner R, Escalard S, Gory B, Lapergue B, Sibon I, Richard S, Labreuche J, Kyheng M, Desilles JP, Blanc R, Piotin M, Halimi JM, Mazighi M; BP-TARGET Trial Investigators. Association of Contrast Enhancement After Reperfusion With Outcomes According to Blood Pressure Lowering in Patients With Acute Ischemic Stroke. Neurology. 2022 Nov 22;99(21):e2385-e2394. doi: 10.1212/WNL.0000000000201173. Epub 2022 Aug 30.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Maier B, Gory B, Lapergue B, Sibon I, Richard S, Kyheng M, Labreuche J, Desilles JP, Blanc R, Piotin M, Mazighi M, Halimi JM; BP TARGET Investigators. Effect of Baseline Antihypertensive Treatments on Stroke Severity and Outcomes in the BP TARGET Trial. Stroke. 2022 Jun;53(6):1837-1846. doi: 10.1161/STROKEAHA.121.037548. Epub 2022 Mar 24.

ReferenceCitation: Anadani M, Maier B, Escalard S, Labreuche J, de Havenon A, Sabben C, Lapergue B, Gory B, Richard S, Sibon I, Desilles JP, Blanc R, Piotin M, Mazighi M; of behalf the BP-TARGET Study Group*. Magnitude of Blood Pressure Change After Endovascular Therapy and Outcomes: Insight From the BP-TARGET Trial. Stroke. 2022 Mar;53(3):719-727. doi: 10.1161/STROKEAHA.121.036701. Epub 2022 Feb 3.

ReferenceCitation: Mazighi M, Richard S, Lapergue B, Sibon I, Gory B, Berge J, Consoli A, Labreuche J, Olivot JM, Broderick J, Duhamel A, Touze E, Qureshi AI, Yavchitz A, Escalard S, Desilles JP, Redjem H, Smajda S, Fahed R, Hebert S, Maier B, Delvoye F, Boursin P, Maacha MB, Obadia M, Sabben C, Blanc R, Savatovsky J, Piotin M; BP-TARGET investigators. Safety and efficacy of intensive blood pressure lowering after successful endovascular therapy in acute ischaemic stroke (BP-TARGET): a multicentre, open-label, randomised controlled trial. Lancet Neurol. 2021 Apr;20(4):265-274. doi: 10.1016/S1474-4422(20)30483-X. Epub 2021 Feb 26.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Centre Hospitalier Régional Universitaire

location_facility: Fondation Ophtalmologique A de Rothschild

location_facility: Hôpital neurologique Pierre Wertheimer, Hospices Civils de Lyon


title: SARCOLOWDOSE : Ultra-low Dose CT Scan and MRI in Thoracic Sarcoidosis

acronym: SARCOLOWDOSE

summary: The goal of this study is to evaluate the diagnostic agreement between, on the one hand, ultra-low dose CT and MRI with UTE pulse sequences, and on the other hand, standard CT scan, to quantify lung parenchyma patterns in thoracic sarcoidosis.

lead_sponsor: Rennes University Hospital

location_facility:
CH de Saint-Brieuc
CHU Rennes
CHU de Brest
CH de Vannes
CH de Bobigny, Hôpital Avicenne
CHU de Nantes
CH de Lorient

region: Bretagne

nom_etablissement: CHRU RENNES

acronyme: SARCO-LOW-DOSE

titre: Tomodensitométrie ultra-basse dose dans l'imagerie de la sarcoïdose thoracique

nom_porteur: LEDERLIN

prenom_porteur: Mathieu


title: Evaluation of the Impact of a Wearable Noninvasive Positive Pressure Ventilation Device on Physical Activity and Quality of Life in Patients With COPD

acronym: VITABREATH

summary: The objective is to assess the impact of a wearable Noninvasive Positive Pressure Ventilation, on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.

primary_purpose: Device Feasibility

lead_sponsor: Icadom

sponsor_collaborators:
Icadom
Philips Respironics

location_facility: Dr Christian PAILLARGUELO Pneumology Office


title: RONNIE - A Multi-Center, Multi-National, Retrospective Medical Record Review to Describe Treatment Patterns and Outcomes for Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

summary: This multi-center, observational study involves reviewing the medical records of approximately 100 adult participants diagnosed with advanced BCC from 01 January 2005 until 31 December 2010. Participant records will be analyzed to identify participant characteristics, treatment patterns and clinical outcomes.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
United Kingdom
France

location_facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche

location_facility: Universitätsmedizin Greifswald; Klinik für Mund-Kiefer-Gesichtschirurgie/Plastische Operationen

location_facility: HELIOS Klinikum Erfurt, Klinik für Hautkrankheiten und Allergologie

location_facility: Hôpital Albert Michallon; Derm Phlebologie Allergologie

location_facility: Hopital de Haut-Leveque; Dermatologie Serv.

location_facility: Manchester Royal Infirmary; Department Of Medicine

location_facility: Hopital Bichat Claude Bernard; Sce Dermatologie

location_facility: Hôpital St Jacques de Besançon; (Dermatology)

location_facility: Policlinico Le Molinette; Clinica Dermatologica

location_facility: Chi Emile Durkheim Site Epinal; Oncologie

location_facility: Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie

location_facility: Università del Piemonte Orientale; Dipartimento di Dermatologia

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik

location_facility: Azienda Sanitaria di Firenze Presidio Palagi - SC Dermatologia II e Fisioterapia Dermatologica

location_facility: Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: Arcispedale Santa Maria Nuova; Dermatologia

location_facility: Hopital Saint Vincent; Consult Dermatologie Enfants

location_facility: Centre Hospitalier Lyon Sud; Dermatologie

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie

location_facility: Klinikum Dorothea Ch.Erxleben; Klinik für Dermatologie und Allergologie

location_facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie

location_facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

location_facility: Western Infirmary; Division of Cardiovascular and Medical Sciences

location_facility: Hopital Timone Adultes; Radiotherapie Oncologie


title: A French Cohort of Transplant Recipients With CMV Infection : Risk Factors for Antiviral Resistance in the Prophylaxis Era. Survey of Pharmacological and Virological Resistance of Cytomegalovirus to Antiviral Therapy in Transplantation.

acronym: ORPHAVIC

summary:
Resistance to antivirals is a growing problem in transplantation.that may concerns up to 5% of patients treated for cytomegalovirus (CMV) syndrome or disease in recent per-protocol studies. This prevalence vary with the organ transplanted and the degree of viral replication and immunosuppression. Less data are available to date from real-life cohorts of patients, and there is no systematic survey of resistance in Europe or in the US. Non response to treatment concerns a larger group of patients and can result either from emergence of a resistant strain (virological resistance), from inadequate dosage of antivirals, or a high degree of immunosuppression, with a poor CMV immune response. The respective clinical impact of virological resistance and clinical resistance (of pharmacological or immunological origin) on graft outcome and long-term survival of patients has never been assessed. High viral loads and persistent replication associated to prolonged exposure to antivirals are known to favor the emergence of resistant strains. Though epidemiology of resistant strains, role of multiple infections, impact of various mutations on degree of resistance to antivirals and outcome remains to be further studied. Most studies are per-protocol studies or short-term studies conducted on limited populations. There are no data in real-life of transplanted patients at the era of enlarged prophylaxis except those from the French survey for cytomegalovirus resistance cohort opened at the end of 2006. From the first data collected on 346 patients we shown a 10,6% prevalence of non-response to therapy with 5,2% of virological resistance (6,1% incidence at one year on 214 patients) with a trend to poorer outcome in case of virological resistance and to the absence of impact of prophylaxis versus preemptive therapy, though larger populations and prolonged follow-up are requested to fulfill all objectives.

We therefore aim to constitute a prolonged survey cohort for CMV resistance with a large number of patients and a prolonged follow-up, to gather data on resistance to antivirals in real-life of transplant patients in an organized data bank, This cohort is in the continuum of our previous cohort started in 2006, granted by the Hospital Clinical Research Program Interregional (PHRC), with the same major objectives and prolonged follow-up of patients.

lead_sponsor: University Hospital, Limoges

location_facility: AP-HP - Hôpital Georges Pompidou - Virologie

location_facility: Virologie - Hôpital La Pitié Salpétrière

location_facility: HCLYON - Virologie - Hôpital La Croix Rousse

location_facility: AP-HP - Hôpital Saint-Antoine - Virologie

intervention_type: Biological


title: Study of the Frequency of Hemorrhages Associated With the Functional Anomalies of Willebrand Factor in Emergency Patients of a Veino Arterial or Veinous ECMO

acronym: WITECMO-H

summary: ECMO has improved the outcome of heart or respiratory failure and carcinogenic shock and are increasingly used. However bleeding complications occurring in up to 50% of patients are poorly understood and worsen the overall results. The aim is to investigate the occurence of bleeding and its frequency according to the type of ECMO either veno-arterial or veno-venous. The investigators also want to assess the relation of bleeding with von Willebrand Factor defects.

location_facility:
Ch Tourcoing
Hôpital Cardiologie, CHU
CH DOUAI
CH Boulogne
Ch Valenciennes
CH ARRAS
CH Dunkerque


title: Quality Control of Pancreatic Islet Intended to Islet Graft

acronym: ISLET CHIP

summary: Islet quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential.

ReferenceCitation: Kusnik-Joinville O, Weill A, Salanave B, Ricordeau P, Allemand H. Prevalence and treatment of diabetes in France: trends between 2000 and 2005. Diabetes Metab. 2008 Jun;34(3):266-72. doi: 10.1016/j.diabet.2008.01.005. Epub 2008 Jun 3.

ReferenceCitation: Gruessner RW, Gruessner AC. The current state of pancreas transplantation. Nat Rev Endocrinol. 2013 Sep;9(9):555-62. doi: 10.1038/nrendo.2013.138. Epub 2013 Jul 30.

ReferenceCitation: Ricordi C, Lacy PE, Finke EH, Olack BJ, Scharp DW. Automated method for isolation of human pancreatic islets. Diabetes. 1988 Apr;37(4):413-20. doi: 10.2337/diab.37.4.413.

ReferenceCitation: Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tetaz R, Badet L, Thivolet C, Morelon E, Frimat L, Penfornis A, Kessler L, Brault C, Colin C, Tauveron I, Bosco D, Berney T, Benhamou PY; GRAGIL Network. Five-Year Metabolic, Functional, and Safety Results of Patients With Type 1 Diabetes Transplanted With Allogenic Islets Within the Swiss-French GRAGIL Network. Diabetes Care. 2015 Sep;38(9):1714-22. doi: 10.2337/dc15-0094. Epub 2015 Jun 11.

publisher_dissemination: American Diabetes Association

ReferenceCitation: Lebreton F, Pirog A, Belouah I, Bosco D, Berney T, Meda P, Bornat Y, Catargi B, Renaud S, Raoux M, Lang J. Slow potentials encode intercellular coupling and insulin demand in pancreatic beta cells. Diabetologia. 2015 Jun;58(6):1291-9. doi: 10.1007/s00125-015-3558-z. Epub 2015 Mar 19.

ReferenceCitation: Renaud S, Catargi B, Lang J. Biosensors in diabetes : how to get the most out of evolution and transpose it into a signal. IEEE Pulse. 2014 May-Jun;5(3):30-4. doi: 10.1109/MPUL.2014.2309577.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
University Hospital, Bordeaux

location_country: Switzerland France

location_facility:
Montpellier University Hospital
Lyon University Hospital
Geneva University Hospital
Besançon University Hospital
Grenoble University Hospital
Nancy University hospital
University hospital of Strasbourg
Clermont Ferrand University hospital

appel_a_projets: PRTS

nom_etablissement: CHU GRENOBLE ALPES

acronyme: ISLET CHIP

titre: ISLET CHIP: Contrôle de Qualité d'Îlots pour la Greffe

nom_porteur: BENHAMOU

prenom_porteur: Pierre-Yves


acronym: TOBRAMUC

summary: The aim of this study is to investigate the efficacy of antibiotic therapy with any antibiotic (IV) and IV (Nebcin®) tobramycin for 5 days followed by Solution for nebuliser inhalation (Tobi®) for 9 days and antibiotic cures using 14 days of tobramycin IV. In the case of positive results, the reduction of the duration of IV treatment of tobramycin from 14 days to 5 days would limit the risk of toxicity.

location_facility: CRCM mixte - CHU de Rouen Hôpital Charles Nicolle

location_facility: CRCM pédiatrique - CHU d'Amiens Hôpital Nord

location_facility: CRCM adulte - CHRU de Lille Hôpital Calmette

location_facility: CRCM pédiatrique - CHRU de Lille Hôpital Jeanne de Flandres

location_facility: CRCM mixte - CHU de Caen Hôpital Côte de Nacre

title: Evaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis.

region: Hauts-de-France

nom_etablissement: CHR LILLE

acronyme: TOBRAMUC

titre: Evaluation de la diminution de la durée de tobramycine par voie IV dans les cures d'antibiotiques pour les  exacerbations aigues de mucoviscidose. Etude en cross-over.

discipline_principale: mucoviscidose , pneumologie , exacerbation , antibiotique , infectieux , combinaison , toxicite

nom_porteur: PREVOTAT

prenom_porteur: Anne


title: Does the Strengthening of the Pancreas in Distal Pancreatectomy Using Endo GIA Reload Reinforced Reduce the Occurrence of Pancreatic Fistula? Multicenter Randomized Prospective Open Study

acronym: REPLAY

summary: Despite an improvement regarding morbidity and mortality since 30 years, especially in expert centers, pancreatic surgery remains currently associated to a significant postoperative morbidity reaching more than 60%. Regarding distal pancreatectomy (DP), the main complication following surgery is the occurrence of postoperative pancreatic fistula (PF) which may be able to lead an increased risk of bleeding, gastroparesis and finally a longer hospital stays. The main risk factors associated to the occurrence of pancreatic fistula are represented by the texture of the pancreatic parenchyma (soft pancreas) and the caliber of the main pancreatic duct (<3mm). Looking for new means of reducing the occurrence of pancreatic fistula is a priority in pancreatic surgery and a genuine public health issue. Currently, no formal recommendations concerning the optimal technical for closure of the distal stump in DP are available. In fact, manual closing by elective suturing or stapling of the main pancreatic duct give similar results. The use of a reinforcing stapling potentially represents a simple way to decrease the occurrence of pancreatic fistula and requires evaluation by a prospective randomized study.

primary_purpose: Other

ReferenceCitation: Merdrignac A, Garnier J, Dokmak S, Regenet N, Lesurtel M, Mabrut JY, Sa Cunha A, Fuks D, Bergeat D, Robin F, Le Pabic E, Boudjema K, Turrini O, Laviolle B, Sulpice L. Effect of the Use of Reinforced Stapling on the Occurrence of Pancreatic Fistula After Distal Pancreatectomy: Results of the REPLAY (REinforcement of the Pancreas in distaL pAncreatectomY) Multicenter Randomized Clinical Trial. Ann Surg. 2022 Nov 1;276(5):769-775. doi: 10.1097/SLA.0000000000005618. Epub 2022 Jul 25.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

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

location_facility: AP-HM - Institut Paoli Calmettes_ service de chirurgie oncologique digestive

location_facility: Service de chirurgie digestive et endocrienne

location_facility: Service de chirurgie générale, digestive et de la transplantation hépatique

location_facility: Centre Hospitalier Universitaire Rennes Pontchaillou

location_facility: Unité d'hospitalisation Chirurgie hépatique, biliaire et pancréatique

location_facility: Service de chirurgie Hépato-pancréato-biliaire


title: Randomized Study Assessing Two Strategies of First Line: a Strategy With Intraperitoneal Chemotherapy and a Strategy With Total Intravenous Strategy, in Patients With Epithelial Advanced Ovarian Cancer

acronym: CHIMOVIP

summary: CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian advanced cancer.

lead_sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

sponsor_collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon


title: A Phase II Safety Trial of Nivolumab in Patients With Metastatic Renal Cell Carcinoma Who Have Progresses During or After Prior Systemic Anti-angiogenic Regimen

acronym: NIVOREN

summary: The primary objective of this study is to evaluate the incidence of high-grade (i.e. Grade 3-4 and Grade 5 of CTCAE v4.0) adverse reactions of interest in patients with metastatic RCC who have progressed during or after receiving at least one prior systemic anti-angiogenic treatment and who are eligible for nivolumab monotherapy.

ReferenceCitation: Rassy E, Dalban C, Colomba E, Derosa L, Alves Costa Silva C, Negrier S, Chevreau C, Gravis G, Oudard S, Laguerre B, Barthelemy P, Goupil MG, Geoffrois L, Rolland F, Thiery-Vuillemin A, Joly F, Ladoire S, Tantot F, Escudier B, Albiges L. Efficacy and Safety of Concomitant Proton Pump Inhibitor and Nivolumab in Renal Cell Carcinoma: Results of the GETUG-AFU 26 NIVOREN Multicenter Phase II Study. Clin Genitourin Cancer. 2022 Oct;20(5):488-494. doi: 10.1016/j.clgc.2022.07.003. Epub 2022 Jul 10.

ReferenceCitation: Billon E, Chanez B, Rochigneux P, Albiges L, Vicier C, Pignot G, Walz J, Chretien AS, Gravis G, Olive D. Soluble BTN2A1 Is a Potential Prognosis Biomarker in Pre-Treated Advanced Renal Cell Carcinoma. Front Immunol. 2021 Apr 20;12:670827. doi: 10.3389/fimmu.2021.670827. eCollection 2021.

publisher_dissemination: Frontiers

ReferenceCitation: Flippot R, Dalban C, Laguerre B, Borchiellini D, Gravis G, Negrier S, Chevreau C, Joly F, Geoffrois L, Ladoire S, Mahammedi H, Rolland F, Gross-Goupil M, Deluche E, Priou F, Laramas M, Barthelemy P, Narciso B, Houede N, Culine S, Oudard S, Chenot M, Tantot F, Chabaud S, Escudier B, Albiges L. Safety and Efficacy of Nivolumab in Brain Metastases From Renal Cell Carcinoma: Results of the GETUG-AFU 26 NIVOREN Multicenter Phase II Study. J Clin Oncol. 2019 Aug 10;37(23):2008-2016. doi: 10.1200/JCO.18.02218. Epub 2019 Jun 13.

sponsor_collaborators:
UNICANCER
Bristol-Myers Squibb

location_facility: Gustave Roussy Cancer Campus Grand Paris

appel_a_projets: PRTK

nom_etablissement: GCS UNICANCER SIEGE

type_etablissement: GCS

titre: Translational Program-Programme Translationel de l'essai GETUG-AFU-26 NIVOREN (Nivolumab chez les patients atteints d'un carcinome rénal métastatique).

nom_porteur: ALBIGES

prenom_porteur: Laurence


title: Comparison of the Clinical Examination and the Joint Ultrasonography in the Evaluation of Disease Activity in Systemic Lupus Patients

acronym: LUPUS

summary: Arthritis is a current manifestation of systemic lupus erythematosus (SLE) and participates to the SLEDAI composite score calculation (0 to 105). Ultrasonography (US) is a validated and sensitive tool for joint assessment. Published studies showed US joint abnormalities in systemic lupus erythematosus patients with or without joint pain. Nevertheless, ultrasonography evaluations were not standardized and no study compared clinical and ultrasonography assessments. The objectives were 1) to describe ultrasonography joint abnormalities in systemic lupus erythematosus population, 2) to compare clinical and ultrasonography standardized joint assessments, 3) to estimate the reliability of clinical swollen joint count (C-SJC) and SLEDAI (C-SLEDAI) score versus ultrasonography-SJC and ultrasonography-SLEDAI.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Chru de Tours
CH du MANS
CHU Hôtel Dieu
Hopital Pontchaillon - Chu de Rennes
Hopital Pellegrin
Chu de Brest
CHR d'Orléans