title: An International Phase III Randomised Trial Comparing the Propofol Consumption During General Anaesthesia With Xenon in Inspiratory Concentrations of 50% and 70% and Total I.V. Anaesthesia Alone in ASA III Patients With Increased Risk of Perioperative Cardiac Complications.

summary: The purpose of this study is to evaluate the quantity of propofol administered with Xenon in two inspiratory concentrations, to maintain comparable depth of anaesthesia during the maintenance period of general anaesthesia.

lead_sponsor: Air Liquide SA

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Groupe Hospitalier Universitaire Caremeau


title: A Phase I/II Clinical Trial of PXD101 in Combination With Idarubicin in Patients With AML Not Suitable for Standard Intensive Therapy

summary: An open-label, non-randomized, multi-centre, Phase I/II trial to assess the efficacy and safety of 2 schedules of PXD101 in combination with idarubicin in patients with AML not suitable for standard intensive therapy.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Valerio Therapeutics

location_country:
Germany
United Kingdom
France

location_facility:
Uni Hospital Marburg
Hôpital St. Louis
Uniklinik Homburg
Universitätsklinikum Ulm
CHU Lapeyronie
Christie Hospital NHS Trust

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Prospective, Randomized, Double-blind, Double-dummy, Forced Titration, Parallel Group Comparison, Multicenter Trial to Compare the Effects of Either Telmisartan (40-80 mg p.o. Once Daily) or Ramipril (5-10 mg p.o. Once Daily) on Renal Endothelial Dysfunction in Hypertensive Patients With Type 2 Diabetes

summary: The primary objective is to evaluate the effect of 9 weeks treatment with either telmisartan or ramipril on NO bioavailability in the renal vasculature, measured as renal plasma flow (RPF) in response to NG-monomethyl-L-arginine (LNMMA) infusion.

design_allocation: Randomized

lead_sponsor: Boehringer Ingelheim

location_country: Germany Spain France

location_facility: Boehringer Ingelheim Investigational Site


title: A Phase 1 Multicenter, Open Label, First-in-Human Dose Escalation Study of AFM28, a Bispecific ICE® That Targets CD123 and CD16A, in Patients With CD123-Positive Relapsed/Refractory Acute Myeloid Leukemia

summary: This study is a First In Human, phase 1, open-label, non-randomized, multi-center, multiple ascending dose escalation study evaluating AFM28 as a monotherapy in subjects with Relapsed/Refractory CD123-positive Acute Myeloid Leukemia (AML). AFM28 is a tetravalent monoclonal antibody targeting the interleukin-3 receptor subunit alpha (IL3RA, CD123) and the low affinity immunoglobulin gamma Fc region receptor III-A (FCGR3A, CD16A). It is developed as an antineoplastic agent for hematologic malignancies known to express CD123. The primary pharmacological Mode of Action of AFM28 is induction of cell death of CD123-expressing cells by stimulating Antibody-Dependent Cell-mediated Cytotoxicity mediated by CD16A-expressing immune cells, primarily Natural Killer cells. The aim of the dose escalation is to determine the Maximum Tolerated Dose (MTD) and/or establish one or more Recommended Phase 2 Doses, based on safety, preliminary anti-leukemic activity and Pharmacokinetics / Pharmacodynamics data.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Affimed GmbH

location_country: Denmark Spain France

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Institut Català d'Oncologia-Hospital Duran i Reynals

location_facility: Hospital Universitari i Politècnic La Fe

status_simplified: Ongoing


title: PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film

summary:
Intrauterine adhesions (IUA) are the major long-term complication of intrauterine procedures and are associated with pelvic pain, menstrual disorders, obstetrical complication and infertility.

Womed Leaf is a medical device specifically designed for intrauterine use that prevents intra-uterine adhesions. It is a film that acts as a mechanical barrier to keep uterus walls separated during healing. It is then naturally discharged through the cervix and vagina in less than 30 days.

The PREG1 clinical investigation is designed to evaluate Womed Leaf safety under clinical conditions, in women scheduled for a hysteroscopic myomectomy as well as its efficacy.

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Weyers S, Capmas P, Huberlant S, Dijkstra JR, Hooker AB, Hamerlynck T, Debras E, De Tayrac R, Thurkow AL, Fernandez H. Safety and Efficacy of a Novel Barrier Film to Prevent Intrauterine Adhesion Formation after Hysteroscopic Myomectomy: The PREG1 Clinical Trial. J Minim Invasive Gynecol. 2022 Jan;29(1):151-157. doi: 10.1016/j.jmig.2021.07.017. Epub 2021 Jul 31.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ipd_sharing_description: No sharing of individual participant data is planed

lead_sponsor: Womed

location_country: Netherlands Belgium France

location_facility:
UZ Gent
CHU Nîmes
Bergman Clinics
CHU Bicêtre (APHP)
Isala Zwolle
Zaans Medical Center

intervention_type: Device


type: EudraCT Number

title: Randomized Controlled Clinical Trial to Assess the Efficacy of a Combination of Autologous Mesenchymal Stem Cells and Biomaterial in Jaw Bone Regeneration Prior to Dental Implant Placement in Comparison to Standard Autologous Bone Grafting

acronym: Maxibone

summary: A randomized controlled clinical multi center trial to assess the efficacy of a combination of autologous mesenchymal stem cells and biomaterial in jaw bone regeneration prior to dental implant placement in comparison to standard autologous bone block grafting.

study_start_date_type: Anticipated

ReferenceType: background

ReferenceCitation: Gjerde C, Mustafa K, Hellem S, Rojewski M, Gjengedal H, Yassin MA, Feng X, Skaale S, Berge T, Rosen A, Shi XQ, Ahmed AB, Gjertsen BT, Schrezenmeier H, Layrolle P. Cell therapy induced regeneration of severely atrophied mandibular bone in a clinical trial. Stem Cell Res Ther. 2018 Aug 9;9(1):213. doi: 10.1186/s13287-018-0951-9.

ReferenceCitation: Rojewski MT, Lotfi R, Gjerde C, Mustafa K, Veronesi E, Ahmed AB, Wiesneth M, Korper S, Sensebe L, Layrolle P, Hellem S, Schrezenmeier H. Translation of a standardized manufacturing protocol for mesenchymal stromal cells: A systematic comparison of validation and manufacturing data. Cytotherapy. 2019 Apr;21(4):468-482. doi: 10.1016/j.jcyt.2019.03.001. Epub 2019 Mar 27.

ipd_sharing: Yes

ipd_sharing_description: De-identified individual participants data for all primary and secondary outcome measures will be made available

lead_sponsor: University of Bergen

sponsor_collaborators:
University of Bergen
Université de Nantes
University of Ulm
Universidad Complutense de Madrid
University of Aarhus
Universitat Internacional de Catalunya
Assistance Publique - Hôpitaux de Paris
European Commission

location_country: Spain Denmark Norway France

location_facility: Syddansk Universitet SDU (University Hospital of Southern Denmark)

location_facility: University of Bergen, Institute of Clonical Dentistry

intervention_type: Procedure

lead_sponsor_type: academique


title: A Randomized Phase I Trial in Patients With Newly Diagnosed, Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Evaluating a Mutanome-directed Immunotherapy.

summary: This is a multicenter, open-label, two arms, randomized, phase I study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with squamous cell carcinoma of the head and neck (SCCHN).

lead_sponsor: Transgene

location_country:
United States
United Kingdom
France

location_facility: Aintree University Hospital NHS Fondation Trust


type: Other Identifier

title: Phase 1b/2 Study of LY3200882 and Pembrolizumab in Patients With Advanced Cancer

summary: The main purpose of this study is to see if the drug LY3200882 which is an inhibitor of transforming growth factor-β (TGFβ) receptor 1 in combination with pembrolizumab is safe and effective in participants with cancer that has spread to other parts of the body.

status: Withdrawn

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Merck Sharp & Dohme LLC

location_country:
United States
Spain
France

location_facility:
Institut Catala d'Oncologia
Hospital Clinic I Provincial
CHU de Besancon Hopital Jean Minjoz
Gustave Roussy
Dana Farber Cancer Institute
Hospital Madrid Norte Sanchinarro

status_simplified: Unknown


title: Is Ablation of All Inducible Atrial Tachycardias an Appropriate Endpoint During Redo Procedures After Initial Persistent AF Ablation? A Multi-center, Randomised, Single-blind Study

acronym: INDUCATH

summary:
In the treatment of symptomatic drug resistant persistent atrial fibrillation (Ps AF), catheter ablation has a class IIA indication. During the follow-up, a significant amount of patients (~50%) will experience atrial tachycardias (AT) recurrence. The endpoint of AT ablation during the second procedure has not been validated. At present, several strategies are considered as good clinical practice.

Main objective: To evaluate if ablation of all inducible AT post AF ablation (ATPAFA) offers as substantial benefit in comparison with ablation of the clinical ATPAF only during a redo procedure post initial persistent AF ablation.

Secondary objectives:

To evaluate the prognosis of non-inducibility during a redo procedure for ATPAFA

ipd_sharing: Undecided

lead_sponsor: AZ Sint-Jan AV

location_country:
Germany
United Kingdom
Belgium
France

location_facility: Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz


title: SYNTAX III REVOLUTION Trial: A Randomized Study to Evaluate the Feasibility of Heart-Team Clinical Decision Making Regarding the Optimal (Surgical or Percutaneous Based) Revascularization Strategy in Patients With Complex Coronary Artery Disease, Based on Non-invasive Coronary CT Angiography (CTA) Imaging Utilising High-definition GE RevolutionTM Multi-slice CT and HeartFlow FFRCT Compared to the Current Standard of Care With Conventional Invasive Coronary Angiography (CA)

acronym: SYNTAX III

summary:
The SYNTAX III Revolution trial is a randomized diagnostic research study that investigates the use of CT scan and angiogram of the heart to help doctors decide which method is the best to improve blood supply to the heart in patients with complex coronary artery disease. Each patient will undergo an angiogram and CT scan per standard of care. The randomization strategy in this study is not between patients but between two teams of doctors, the so-called "Heart Teams", will be randomized: in the first round, team 1 assesses the angiogram, and team 2 assesses the CT scan. Then they make a decision about which treatment would be the best to treat complex coronary artery disease. In the second round, both teams see the imaging method that they did not see in the first round, and make the decision again. The final decision on the clinical treatment strategy is at the sole discretion of the Heart Team and there are no criteria described in SYNTAXIII Revolution protocol leading influencing this final decision.

Hypothesis: Determination of the best treatment strategy for coronary artery disease based on a CT scan will result in similar decisions as based on invasive coronary angiography.

study_type: Observational

time_perspective: Cross-Sectional

ReferenceCitation: Andreini D, Modolo R, Katagiri Y, Mushtaq S, Sonck J, Collet C, De Martini S, Roberto M, Tanaka K, Miyazaki Y, Czapla J, Schoors D, Plass A, Maisano F, Kaufmann P, Orry X, Metzdorf PA, Folliguet T, Farber G, Diamantis I, Schonweiss M, Bonalumi G, Guglielmo M, Ferrari C, Olivares P, Cavallotti L, Leal I, Lindeboom W, Onuma Y, Serruys PW, Bartorelli AL; SYNTAX III REVOLUTION Investigators. Impact of Fractional Flow Reserve Derived From Coronary Computed Tomography Angiography on Heart Team Treatment Decision-Making in Patients With Multivessel Coronary Artery Disease: Insights From the SYNTAX III REVOLUTION Trial. Circ Cardiovasc Interv. 2019 Dec;12(12):e007607. doi: 10.1161/CIRCINTERVENTIONS.118.007607. Epub 2019 Dec 13.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Collet C, Onuma Y, Andreini D, Sonck J, Pompilio G, Mushtaq S, La Meir M, Miyazaki Y, de Mey J, Gaemperli O, Ouda A, Maureira JP, Mandry D, Camenzind E, Macron L, Doenst T, Teichgraber U, Sigusch H, Asano T, Katagiri Y, Morel MA, Lindeboom W, Pontone G, Luscher TF, Bartorelli AL, Serruys PW. Coronary computed tomography angiography for heart team decision-making in multivessel coronary artery disease. Eur Heart J. 2018 Nov 1;39(41):3689-3698. doi: 10.1093/eurheartj/ehy581.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central;air.unimi.it

unpaywall_oa_status: hybrid

publisher_dissemination: Oxford University Press

ipd_sharing_description:
The research data will be entered on separate forms and stored under a code number, according to prevailing legal requirements. No names or other personal data will be stored. Only the study doctor will hold the information to link the code to the patients. The encoded data will be processed, analysed and reported by the research employees of this study, who have an obligation of secrecy.

Representatives of the sponsor or members of the Ethics Committee (EC) and regulatory authorities within Europe can have access to the medical files in order to inspect the correctness of the research data. Data may be provided to representatives and affiliates of the industries supporting the study: General Electric and HeartFlow Inc. It is possible that the results of this study are presented or published in medical journals; this will always be without mention of the identity of the patients.

lead_sponsor: ECRI bv

collaborators:
GE Healthcare
HeartFlow, Inc.

sponsor_collaborators:
ECRI bv
GE Healthcare
HeartFlow, Inc.

location_country: Germany Italy Switzerland Belgium France

intervention_type: Radiation


title: Treatment of REfractory Overactive BLadder With the AXonics Sacral Neuromodulation System (RELAX-OAB)

acronym: RELAX-OAB

summary: The RELAX-OAB (Treatment of REfractory Overactive BLadder with the AXonics Sacral Neuromodulation System) is a post-market clinical follow-up (PMCF) study designed to confirm the performance of the Axonics Sacral Neuromodulation (SNM) System as an aid in the treatment of the symptoms of overactive bladder (OAB) as well as capturing patient satisfaction and quality of life data.

lead_sponsor: Axonics, Inc.

location_country:
United Kingdom
Netherlands
Belgium
France

location_facility:
Erasmus Medical Center
Chu De Nantes - Hôtel-Dieu
Maastricht University Medical Center
UZ Leuven
Hospices Civils de Lyon
University College London Hospital


title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Trial, Investigating the Efficacy and Safety of Repeated Lamazym Treatment of Subjects With Alpha-Mannosidosis.

summary: The overall objective of this trial is to evaluate the efficacy and safety of repeated Lamazym i.v. treatment, compared with placebo, in subjects 5-35 years of age with alpha-Mannosidosis

ReferenceCitation: Borgwardt L, Stensland HM, Olsen KJ, Wibrand F, Klenow HB, Beck M, Amraoui Y, Arash L, Fogh J, Nilssen O, Dali CI, Lund AM. Alpha-mannosidosis: correlation between phenotype, genotype and mutant MAN2B1 subcellular localisation. Orphanet J Rare Dis. 2015 Jun 6;10:70. doi: 10.1186/s13023-015-0286-x.

ReferenceCitation: Borgwardt L, Thuesen AM, Olsen KJ, Fogh J, Dali CI, Lund AM. Cognitive profile and activities of daily living: 35 patients with alpha-mannosidosis. J Inherit Metab Dis. 2015 Nov;38(6):1119-27. doi: 10.1007/s10545-015-9862-4. Epub 2015 May 28.

ReferenceCitation: Harmatz P, Cattaneo F, Ardigo D, Geraci S, Hennermann JB, Guffon N, Lund A, Hendriksz CJ, Borgwardt L. Enzyme replacement therapy with velmanase alfa (human recombinant alpha-mannosidase): Novel global treatment response model and outcomes in patients with alpha-mannosidosis. Mol Genet Metab. 2018 Jun;124(2):152-160. doi: 10.1016/j.ymgme.2018.04.003. Epub 2018 Apr 18.

ReferenceType: result

ReferenceCitation: Borgwardt L, Guffon N, Amraoui Y, Dali CI, De Meirleir L, Gil-Campos M, Heron B, Geraci S, Ardigo D, Cattaneo F, Fogh J, Van den Hout JMH, Beck M, Jones SA, Tylki-Szymanska A, Haugsted U, Lund AM. Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial. J Inherit Metab Dis. 2018 Nov;41(6):1215-1223. doi: 10.1007/s10545-018-0185-0. Epub 2018 May 30.

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

repository_institution: Erasmus University Rotterdam - EUR Research Repository

version: submittedVersion

publisher_dissemination: Wiley

lead_sponsor: Zymenex A/S

sponsor_collaborators:
Zymenex A/S
European Commission

location_country:
Germany
Poland
United Kingdom
Denmark
France

location_facility: The Children's Memorial Health Institute Warsaw, Department of Metabolic Diseases, Al Dzieci Polskich 20

location_facility: Center for Metabolic Diseases, Department of Clinical Genetics, Juliane Marie Centre, Copenhagen University Hospital, Blegdamsvej 9

location_facility: Hôpital Femme Mère Enfant, Lyon, 59 boulevard Pinel

location_facility: Hôpital Trousseau, Service de neuropédiatrie, Centre Référence des Maladies Lysosomales, 26 avenue du Docteur Arnold Netter

location_facility: Genetic Medicine, 6th floor, St Mary's Hospital, Oxford Road,

location_facility: Universitätsmedizin Mainz, Zentrum für Kinder- und Jugendmedizin, Langenbeckstrasse 1


title: A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects

summary: This trial is conducted in Europe. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia.

status: Terminated

ReferenceCitation: Waters EK, Sigh J et al.: Trombin generation is increased in plasma from healthy males who have received concizumab, an antibody against tissue factor pathway inhibitor (ExplorerTM 2); Journal of Thrombosis and Haemostasis, Abstracts 2015; 13(Suppl. S2): 1-997(AS019)

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
United Kingdom
Austria
Spain
France


title: A Multi-centre, Two-stage, Open Label Phase II Study to Assess the Efficacy and Safety of APO866 in the Treatment of Patients With Advanced Melanoma.

summary: This phase II study is designed to determine the efficacy and safety of APO866 for the treatment of patients with advanced cutaneous melanoma. APO866 has shown to induce growth inhibition in cultures of human melanoma cells as well as in animal models with subcutaneously implanted melanoma tumors. APO866 was considered to be safe and well tolerated in a phase I study that treated 24 patients with advanced cancer. In that study one of the two patients with advanced melanoma had a stable disease for 5 months with size reduction of some lesions. APO866 is administered by intravenous infusion continuously for 96 hours that is repeated every 4 weeks. Patients will receive 3 cycles of treatment and the primary efficacy endpoint will be assessed at Week 16. Patients will be follow-up for 12 months.

location_country: Germany Switzerland Austria France

location_facility: University Clinic for Dermatology, Medical Faculty of Mannheim of the Heidelberg University

location_facility: Department of Dermatology, University Hospital of Zürich

location_facility: Department of Dermatology, Hopital Henri Modor

location_facility: Department of Dermatology, Medical University Graz

location_facility: Department of Dermatology, Charité University Hospital Berlin


title: A Phase 2 Study Evaluating the Bispecific CD3xCD20 Antibody GLOfitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (CHOP) in Patients With RIchter Syndrome as Frontline therapY

acronym: GLORIFY

summary:
This is a national clinical trial, multicentric (28 centers), non-randomized phase 2 study.

Population: Patients with previously untreated Richter's syndrome (RS), defined as the occurrence of an aggressive lymphoma (of diffuse large B-cell lymphoma histology) in a patient with chronic lymphocytic leukemia (CLL).

Study treatment:

The duration of each cycle is 21 days.

Cycle 1:

Participants will receive standard of care doses of R-CHOP in cycle 1 as follows:

Rituximab 375 mg/m² IV Day 1
Cyclophosphamide 750 mg/m² IV Day 1
Doxorubicin 50 mg/m² IV Day 1
Vincristine 1.4 mg/m² [capped at 2.0 mg] IV Day 1
Prednisone 60 mg/m2 per day PO Day 1-5

Cycle 2:

In order to minimize cytokine release syndrome (CRS), participants will then receive G-CHOP as cycle 2 (with obinutuzumab) and glofitamab:

Obinutuzumab 1000 mg single dose IV Day 1
Cyclophosphamide 750 mg/m² IV Day 1
Doxorubicin 50 mg/m² IV Day 1
Vincristine 1.4 mg/m² [capped at 2.0 mg] IV Day 1
Prednisone 60 mg/m2 per day PO Day 1-5
Glofitamab : administered intravenously (IV) as a step-up dose on Days 8 (2.5 mg) and 15 (10 mg)

Cycle 3-6:

Participants will receive standard of care doses of R-CHOP and Glofitamab as follows:

Rituximab 375 mg/m² IV Day 1
Cyclophosphamide 750 mg/m² IV Day 1
Doxorubicin 50 mg/m² IV Day 1
Vincristine 1.4 mg/m² [capped at 2.0 mg] IV Day 1
Prednisone 60 mg/m2 per day PO Day 1-5
Glofitamab : 30 mg IV Day 8

Cycle 7 and 8 (only for patient in Complete Response or Partial response after Cycle 6):

Cycle 7 and 8 consist of 2 infusions of glofitamab only at D8C7 and D8C8:

● Glofitamab : 30 mg IV Day 8

Primary endpoint Percentage of participants with a complete response as assessed by the investigator using the Cheson IWG 2014 Lugano Classification (i.e. Deauville scale 1-3) after 6 cycles of R/G-CHOP + glofitamab or at permanent treatment discontinuation.

End of treatment is defined as after 6 cycles of R/G-CHOP + glofitamab. Permanent treatment discontinuation is defined as the discontinuation of all treatments (R/G-CHOP, glofitamab).

status: Not yet recruiting

lead_sponsor: French Innovative Leukemia Organisation

sponsor_collaborators:
French Innovative Leukemia Organisation
Hoffmann-La Roche

location_facility: ROUEN - Centre Henri Becquerel - Service Hématologie Clinique

location_facility: APHP - Hôpital Saint-Antoine - Hématologie et thérapie cellulaire

location_facility: BAYONNE - CH de la Côte Basque - Hématologie

location_facility: RENNES - CHU Pontchaillou - Hématologie Clinique

location_facility: LILLE GHICL - Hôpital Saint Vincent de Paul

location_facility: Toulouse - IUCT Oncopole - Service d'Hématologie

location_facility: MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique

location_facility: APHP - Hôpital Pitié Salpêtrière - Hématologie

location_facility: APHP - Hôpital Saint-Louis - Hématologie adultes


title: Comparison of Permanent Intracranial Stenting Versus no Stenting in Stroke Secondary to Refractory Acute Proximal Vascular Occlusion: a Multicenter Randomized Controlled Trial

acronym: PISTAR

summary: Clot extraction failure during mechanical thrombectomy is a major concern in the management of acute ischemic stroke related to large vessel occlusions. Indeed, it can occur in up to 10 to 30% of cases and, therefore, is associated with a very poor prognosis. These refractory occlusions frequently occur when an underlying intracranial atherosclerotic disease is present. Thus, one of the most promising rescue technique consists of placing a permanent intracranial stent, under dual antiplatelet therapy over the target refractory occlusion. This strategy is well studied in coronary occlusions where the atheroscotic mechanism is highly prevalent. However, as the ischemiated brain is at much higher risk of hemorrhagic complications, such strategy entails a greater risk. This raises the question of whether such risk is worth the reward of obtaining reperfusion. The investigators designed this randomized study in order to evaluate whether a strategy combining rescue pemanent intracranial stenting with the best medical treatment is superior to the best medical treatment alone in acute refractory large vessel occlusions.

ipd_sharing_description: Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: APHP • Assistance Publique des Hôpitaux de Paris, Pitié-Salpêtrière hospital


title: Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients: a Collaborative Janssen - IFM Study IFM 2023-01: TEC-CARE

acronym: TEC-CARE

summary:
200 adult patients with multiple myeloma receiving teclistamb will be included. Effectiveness, safety, and condition of use of teclistamab in early access program (post-MA) will be assessed. Primary objective is the evaluation of overall response rate (ORR) of teclistamab according to IMWG criteria.

This is a multicenter, prospective, observational study.

time_perspective: Prospective

lead_sponsor: Intergroupe Francophone du Myelome

sponsor_collaborators:
Intergroupe Francophone du Myelome
Janssen-Cilag Ltd.

location_facility:
Hopital de la cote Basque
CH d'ANNECY
CHU Toulouse
CHU CAEN
Chu de Rennes
CHU de Lyon
CHU de Lille
CH Bretagne Atlantique
CH Perpignan
Chu Dijon
Hopital Necker
CH Dunkerque
Chu de Nantes
Institut Paoli Calmette
CHU de Nice
CHU de Tours
Hopital Novo
CHU Bordeaux
Hopital saint louis
CH de METZ


title: A Prospective Cohort Study to Evaluate Molecular pRognostic Factors and Resistance Mechanisms to Osimertinib in Adjuvant Treatment of Completely Resected pIB-IIIA Non-small Cell Lung Carcinoma With Common EGFR Mutations (L858R and Del19)

acronym: ROSIE

summary: IFCT-2202 ROSIE study aims to incorporate a broad-panel centralized NGS testing at baseline in all patients with completely resected NSCLC with common EGFR mutation after confirmation of an optimal preoperative extension assessment and with a centralized review of the quality of the surgical excision. Furthermore, the IFCT-2202 ROSIE study also aims to study the molecular events associated with relapse on, or after osimertinib exposure, that should result in the opportunity to accede to optimal treatment in case of metastatic relapse.

primary_purpose: Diagnostic

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
Créteil - CHI
Montpellier - CHU
Strasbourg - NHC
Paris - Tenon
Boulogne - Ambroise Paré
Clermont-Ferrand - CHU
Bayonne - CH
Lyon - CRLCC
Paris - Pitié-Salpêtrière
Caen - CHU
Paris - Bichat
Bordeaux - CHU
Dijon - CHU Bocage
La Roche-Sur-Yon - CH
Lille - CHU
Metz - Hôpital Robert Schuman
Pau - CHG
Colmar - CH
Marseille - APHM
Paris - HEGP
Le Mans - CHG
Toulon - CHI
Lyon - URCOT
Tours - CHU
Suresnes - Foch
Toulouse - CHU
Nice - CHU
Annecy - CH
Rennes - CHU
Orléans - CHR
Paris - Hôpital Cochin
Rouen - CHU
Montpellier - ICM
Grenoble - CHU
Poitiers - CHU
Angers - CHU

intervention_type: Other


title: Open-label, Phase 2 Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia

acronym: OGILAR

summary:
Approximately 30% of adult AML subjects are refractory to induction therapy. Furthermore, of those who achieve CR, approximately 75% will relapse. FLT3-mutated AML comprise an especially poor prognosis group.

Until now, there was no established standard for relapsed subjects with FLT3 mutations and less than 20% will achieve CR with subsequent treatment.

In phase 3 Study ADMIRAL Trial, gilteritinib has resulted in CRc in over 25% of subjects receiving 120 mg/day before on study HSCT. With this treatment, the median overall survival is at 9.3 months, furthermore, gilteritinib was well tolerated at the proposed doses. This study has been designed for R/R patients for which gilteritinib as single agent has been showed to be superior to high- and low-intensity chemotherapy (Perl, NEJM 2019, Supp Table S4) and patients included in this study will receive this treatment. Beyond high- or low-intensity chemotherapy, other options available are best supportive car or other clinical trials.

The aim of this study is to assess the efficacy and safety of the addition of oral-azacitidine to salvage treatment by gilteritinib in subjects ≥18 years of age with relapsed/refractory FLT3-mutated acute myeloid leukemia

sponsor_collaborators:
French Innovative Leukemia Organisation
Acute Leukemia French Association

location_facility: ICANS - Institut de cancérologie de strasbourg europe

location_facility: Centre de Lutte Contre le Cancer H. Becquerel


title: Phase III, Multicenter, Open Label, Randomized, Controlled Study Investigating Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma

summary:
This is an open label, multi-center, international, randomized phase III trial to compare the efficacy of Mosunetuzumab-Lenalidomide with investigator choices exclusively in R/R MZL patients. Patients with a proven diagnosis of EMZL, SMZL or NMZL subtypes and previously treated with at least one prior systemic treatment and not more than three prior lines are eligible. Previous treatment line must include at least one systemic line with a drug targeting CD20 (monoclonal antibody at least 2 cycles) with or without chemotherapy (R-CHOP, R-Bendamustine, R-CVP, R-Chlorambucil at least 2 cycles) or targeted treatment such as Ibrutinib.

The patients will be Randomized as follows:

Arm A - Experimental arm:

• Mosunetuzumab-Lenalidomide

Arm B - Comparator arms ( Investigator Choices):

Rituximab-Lenalidomide
Rituximab-Bendamustine
Rituximab-CHOP

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: CH de la Côte Basque - Hôpital de Bayonne


title: GATA-2 Project: Retrospective and Prospective Exploratory Study for Characterisation of Predictive Parameters of Clonal Evolution in Subjects With GATA2 Germline Mutation

summary:
This trial is a translational, open-label, multi-site, retrospective and prospective cohort study of 250 patients aiming to characterize predictive parameters of clonal evolution in a population of subjects carrying the germline GATA2 mutation.

This study will be conducted on a population of subjects either with previous germline GATA2 mutation identified or newly identified for germline GATA2 mutation in the context of routine care.

Prospective cohort:

150 subjects will be included in this interventional prospective cohort study:

Alive subjects previously identified with a germline GATA2 mutation through the already existing "Neutropenia database";
Subject identified in the investigating centers in the context of a newly identified germline GATA2 mutation.

For each included patient, biological samples (blood and bone marrow samples) will be collected at baseline visit and then during 5 years, according to the samples taken in the standard practice. No additional sampling will be performed for the study.

Retrospective cohort:

Subjects (100 cases in total) previously identified with germline GATA2 mutation through the already existing "Neutropenia database" and with the following features may enter the retrospective cohort:

Deceased patients,
Lost to follow-up patients. Clinical follow-up data will be obtained from this database and/or patient's medical report.

For each retrospective case, archived blood and bone marrow samples (collected in a sanitary setting) will be sent to sponsor's centralized unit for analysis.

primary_purpose: Other

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)


title: Prospective, Multicenter, Randomized, Parallel Groups Study Comparing the Safety and the Efficacy of the Administration of One Intra-articular Injection of 4.8 ml (HO-1) or Three Intra-articular Injections of 2.2 ml (HS-3) of Pandora Gel to One Intra-articular Injection of 2.5 ml (SINOVIAL®ONE), in Symptomatic Gonarthrosis

summary:
The knee osteoarthritis is a frequent degenerative condition that mainly affects subjects over 60, population often weakened by numerous comorbidities and concomitant treatments, justifying the development of new therapies.

The viscosupplementation is a symptomatic treatment for knee osteoarthritis ; the objective of this intra-articular injection of hyaluronic acid is to reduce knee pain and improve mobility. In practice, there are two protocols to administer viscosupplementation : in a single injection or in three injections performed weekly.

The present clinical investigation has the objective to evaluate the safety and efficacy of use of Pandora, a hyaluronic acid associated with tranexamic acid, in a single injection (HO-1) or in three injections performed weekly (HS-3), compared to a referred and commercialized medical device.

ReferenceCitation: Sellam J, Courties A, Eymard F, Ferrero S, Latourte A, Ornetti P, Bannwarth B, Baumann L, Berenbaum F, Chevalier X, Ea HK, Fabre MC, Forestier R, Grange L, Lellouche H, Maillet J, Mainard D, Perrot S, Rannou F, Rat AC, Roux CH, Senbel E, Richette P; French Society of Rheumatology. Recommendations of the French Society of Rheumatology on pharmacological treatment of knee osteoarthritis. Joint Bone Spine. 2020 Dec;87(6):548-555. doi: 10.1016/j.jbspin.2020.09.004. Epub 2020 Sep 12.

ReferenceCitation: Balazs EA. Viscosupplementation for treatment of osteoarthritis: from initial discovery to current status and results. Surg Technol Int. 2004;12:278-89.

ReferenceCitation: Concoff A, Sancheti P, Niazi F, Shaw P, Rosen J. The efficacy of multiple versus single hyaluronic acid injections: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Dec 21;18(1):542. doi: 10.1186/s12891-017-1897-2.

ReferenceCitation: Diracoglu D, Tuncay TB, Sahbaz T, Aksoy C. Single versus multiple dose hyaluronic acid: Comparison of the results. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):881-886. doi: 10.3233/BMR-160714.

ReferenceCitation: Bhadra AK, Altman R, Dasa V, Myrick K, Rosen J, Vad V, Vitanzo P Jr, Bruno M, Kleiner H, Just C. Appropriate Use Criteria for Hyaluronic Acid in the Treatment of Knee Osteoarthritis in the United States. Cartilage. 2017 Jul;8(3):234-254. doi: 10.1177/1947603516662503. Epub 2016 Aug 10.

ReferenceCitation: Li J, Liu R, Rai S, Ze R, Tang X, Hong P. Intra-articular vs. intravenous administration: a meta-analysis of tranexamic acid in primary total knee arthroplasty. J Orthop Surg Res. 2020 Dec 2;15(1):581. doi: 10.1186/s13018-020-02119-1.

ReferenceCitation: Ng W, Jerath A, Wasowicz M. Tranexamic acid: a clinical review. Anaesthesiol Intensive Ther. 2015;47(4):339-50. doi: 10.5603/AIT.a2015.0011. Epub 2015 Mar 23.

ReferenceCitation: Jules-Elysee KM, Tseng A, Sculco TP, Baaklini LR, McLawhorn AS, Pickard AJ, Qin W, Cross JR, Su EP, Fields KG, Mayman DJ. Comparison of Topical and Intravenous Tranexamic Acid for Total Knee Replacement: A Randomized Double-Blinded Controlled Study of Effects on Tranexamic Acid Levels and Thrombogenic and Inflammatory Marker Levels. J Bone Joint Surg Am. 2019 Dec 4;101(23):2120-2128. doi: 10.2106/JBJS.19.00258.

lead_sponsor: Labrha

sponsor_collaborators: Labrha Statitec

location_country: Monaco France

location_facility: Cabinet Médical Pluridisciplinaire Wallach

location_facility: Groupe Hospitalier de la Haute Saône - Hôpital de Vesoul

location_facility: Centre de Recherche Rhumatologique et Thermal


title: FLUCLORIC: Randomized Multicentric Phase III Study Comparing the Efficacy of 2 Reduced Intensity Conditioning Regimens (Clofarabine/Busulfan vs Fludarabine/Busulfan) in Adults With AML and Eligible to Allogeneic Stem Cell Transplantation

acronym: FLUCLORIC

summary: Relapse remains the main cause of death in patients with myeloid malignancies, especially after an allotransplant. Using drugs with higher anti-leukemic activity as part of the conditioning regimen is one of the strategies to decrease relapse incidence in this population. Retrospective studies have shown that clofarabine can achieve impressive results compared to the use of fludarabine in acute myeloid leukemia (AML) as part of the conditioning regimen. Confirming such results in a prospective manner would definitely establish the CloB2A2 as a superior reduced-intensity conditioning (RIC) regimen compared to the FB2A2 for AML patients.302 AML patients (151 in each arm) in complete remission at transplant will be included with the main objective to demonstrate a significant better 2-year overall survival for CloB2A2 cases (70% vs 55%). A cost-utility analysis and a cost-effectiveness analysis will be also performed as well as an assessment of the quality of life after transplant. Clofarabine will be furnished to all centers. The duration of the study will be 5 years with 3 years of inclusion and 2 years of follow-up for each patient.

lead_sponsor: Nantes University Hospital

location_facility:
CHU Rennes
CHU Brest
CHU Limoges
CHU Lyon
CHU Amiens
CRLC Toulouse
CHU St-Etienne
CRLC Caen
CHU de Nantes
CHU Angers
CHU Montpellier
St-Antoine, APHP
CHRU Nancy
CHU Clermont-Ferrand
CHRU Lille
Institut Paoli Calmettes
CHU Grenoble
Pitie-Salpetriere, APHP
CHU Besançon
CHU Paris St-Louis
CHU Poitiers
CHU Bordeaux
APHP Créteil


title: Impact of the Non-invasive Oxygen-reserve-index (ORI) Versus Standard of Care on Peripheral Oxygen Saturation (SpO2) During Endotracheal Intubation (ETI) in Intensive Care Unit: Randomised Superiority Multi-center 2 Arms, Open Trial

summary: The purpose of this study is to determine whether ORI monitoring increases the lowest oxygen saturation level during the interval between the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) and the end of the second minute after successful ETI.

primary_purpose: Supportive Care

location_facility:
HCL - Hôpital Edouard Herriot
CHU de Rennes
CH d'Haguenau
CH de Roanne
Hôpital Saint-Louis
APHP - Hôpital Louis Mourier
CHU de Dijon
Anthony LEMIEUR
CHU Angers
CHR d'Orléans
CHU de Nice
CH Argenteuil
CH de Versailles
CHR Lille - Hôpital Roger Salengro
CHRU de Strasbourg
CHD Vendée
CHRU de Tours
CHU Bordeaux
APHP - Hôpital Cochin


title: Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia: a Multicenter, Randomized, Parallel-group, Evaluator Blinded, Phase III Clinical Trial

acronym: HIATUS

summary:
The large hiatal hernia (LHH) now represents approximately 50% of laparoscopic antireflux surgical practice.

In a non-comparative retrospective study of 399 patients operated for LHH with onlay patch of a bioprosthetic absorbable (Gore® Bio-A® HH0710) mesh with a mean follow-up of 44 months, 16% had a symptomatic recurrence with 7,9% requiring reoperation, one patient had oesophageal stenosis. No comparative effectiveness data exist to date.

Hypothesis: the incidence of postoperative hiatus hernia would be reduced by the addition of biosynthetic absorbable mesh reinforcement to a standardized suture repair technique, as compared to laparoscopic repair without mesh, without increasing the risk of complications.

The main objective is to compare the radiologic recurrence rate at 2 years between standardized herniorrhaphy with onlay biosynthetic absorbable mesh repair versus standardized herniorrhaphy with no mesh in symptomatic LHH.

lead_sponsor: University Hospital, Bordeaux

location_facility: Polyclinique du bois, Hôpital privé Le Bois

location_facility: Hôpital Côte de nacre, CHU Caen Normandie


title: A Phase II Study Assessing the Efficacy of Etoposide Free Chemotherapy Plus Durvalumab (MEDI4736) in First Line Extensive Disease Small Cell Lung Cancer (SCLC)

acronym: TAXIO

summary: The current study is intended to be a "proof of concept" to evaluate the potential value of synergy between paclitaxel carboplatin and immunotherapy. If a signal clearly shows superiority over the CASPIAN data , we will have arguments to think that the combination of paclitaxel and carboplatin is more suitable for synergy with immunotherapy than the standard etoposide and carboplatin.

sponsor_collaborators: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
Créteil - CHI
Paris - Tenon
Boulogne - Ambroise Paré
Cholet - CH
Chambéry - CH
Besançon - CHU
Marseille - Hôpital Européen
Morlaix - CH
Bordeaux - CHU
Paris - Bichat
Dijon - CHU Bocage
Amiens - Clinique de l'Europe
Abbeville - CH
Vandoeuvre-lès-Nancy - CRLCC
Colmar - CH
Marseille - APHM
Le Mans - CHG
Lyon - URCOT
Tours - CHU
Annemasse - CH
Villefranche sur Saône - CH
Toulon - Sainte Anne HIA
Rennes - CHU
Orléans - CHR
Paris - Hôpital Cochin
Grenoble - CHU
Angers - CHU


title: Observatory for Patients Treated for Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia With Oncogenetic Features.

acronym: ALLTARGETOBS

summary: In order to improve the outcome of relapsed and/or refractory T-cell precursor acute lymphoblastic leukemia (T-ALL) patients, and to facilitate the use of oncogenetic targeted therapies in these patients, we set up an observational cohort, collecting clinical and biological information's from patients with T-ALL in relapse or refractory, as well as the use or not of a targeted therapy. The analysis of the cohort will allow us to evaluate the impact of this therapeutic strategies on the patients' fate, and to facilitate access to innovation and personalized medicine for these patients.

time_perspective: Other

lead_sponsor: Versailles Hospital

location_facility: CHU Centre Hospitalier Universitaire de Saint-Étienne - Loire

location_facility: Centre Hospitalier Emile Muller de Mulhouse

location_facility: Centre anti-cancer Nice : Antoine Lacassagne

location_facility: Centre Hospitalier Universitaire de CAEN


title: SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer

acronym: SUGAR

summary:
This is a phase II, multicenter, randomized open-label and comparative trial designed to study the effectiveness and the safety of androgen receptor antagonist (darolutamide) combined with surgery in patients with high-risk and/or locally advanced prostate cancer.

In this trial, patients will be assigned in one of the two following treatments arms:

Arm A (control arm): Surgery alone (radical prostatectomy with lymph node dissection)
Arm B (experimental arm): Peri-operative darolutamide + surgery (radical prostatectomy with lymph node dissection)

A total of 240 patients will have to be randomized with 120 patients in the control arm and 120 patients in the experimental arm.

sponsor_collaborators:
Institut Claudius Regaud
Bayer

location_facility: Institut Universitaire Du Cancer Toulouse - Oncopole


title: Anticoagulant Regimens Given to Achieve Thrombus Regression and Reduce Clinical Outcomes Among Patients With Non Device-related Intra-cardiac Thrombus: a Randomized Assessment Under Direct Oral Anticoagulant and Vitamin-k Antagonist Therapy

acronym: ARGONAUT

summary:
Left ventricular thrombus is found in 10 to 25% of patients with impaired left ventricular function following ST-segment elevation myocardial infarction and up to 20% in dilated cardiomyopathy in observational studies. Likewise, the incidence of atrial thrombus among atrial fibrillation patients treated by vitamin K antagonist (VKA) is between 0.25% and 7%. Despite anticoagulant therapy, intra-cardiac thrombus remains a severe complication associated with a high risk of systemic embolism and subsequent mortality but also bleeding events related to the anticoagulation therapy. The class of non-vitamin K antagonist direct oral anticoagulant (DOA) has emerged in the last decades and has systematically surpassed VKA in the different clinical settings by providing at minimum a similar efficacy and a better safety profile. In the absence of randomized study in the specific clinical setting of intracardiac thrombus, international Guidelines recommend, on the basis of expert opinion, the use of VKA for at least 3 to 6 months in case of left ventricular thrombus and there is no specific recommendation for thrombus management from other cardiac localizations.

In comparison to VKA, the easier management and the large evidence of better safety of DOA make it an interesting anticoagulant strategy. Data for left ventricule thrombosis treatment are limited and only supported by observational cohorts. However, these recent cohorts have shown promising data in this indication reporting similar thrombus regression following DOA in comparison to VKA and similar ischemic outcomes although no head-to-head comparison would be powered.

As a consequence, the multicentric randomized ARGONAUT trial aims to confirm these results and evaluate the impact of DOA compared to VKA on thrombus regression and clinical outcomes among patients with intracardiac thrombus, regardless of the thrombus localization and any underlying heart disease.

ReferenceCitation: Lattuca B, Bouziri N, Kerneis M, Portal JJ, Zhou J, Hauguel-Moreau M, Mameri A, Zeitouni M, Guedeney P, Hammoudi N, Isnard R, Pousset F, Collet JP, Vicaut E, Montalescot G, Silvain J; ACTION Study Group. Antithrombotic Therapy for Patients With Left Ventricular Mural Thrombus. J Am Coll Cardiol. 2020 Apr 14;75(14):1676-1685. doi: 10.1016/j.jacc.2020.01.057.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_country: Réunion France

location_facility:
CHU Toulouse
CHU Nice
CHU Rennes
CH de la Région Annecienne
AP-HP CHU Lariboisière
CHU Brest
CHU Limoges
CH Joffre Perpignan
Hôpital Privé Dijon Bourgogne
AP-HP CHU Bichat
Ch Avignon
AP-HP Hopital Ambroise Paré
CH Chartres
CHU de Nimes
CH Compiègne Noyon
CHR Metz-Thionville
CHU Angers
CHU Pitié-Salpêtrière
CHU Nantes
Hôpital Cardiologique du Haut Lévêque
CHU Gabriel Montpied
AP-HM CHU La Timone
Clinique du Millenaire
CHU La réunion NORD
Centre Cardiologique du Nord
CHU Strasbourg
CH Francois Mitterand
Hôpital Cardiovasculaire Louis Pradel
CH Bastia
CHU Arnaud de Villeneuve
CHU Poitiers
Ap-Hp Hegp
CHU Lille
Groupe Hospitalier Mutualiste


title: A Phase I/II, Open-label, Single Arm, Multicenter Dose-finding Study Assess the Safety and Preliminary Efficacy of Oral Azacitidine CC-486 (ONUREG) in Combination With Venetoclax (VENCLYXTO) in Previously Untreated Higher-risk Myelodysplastic Syndromes Ineligible for Allogenic Transplantation

summary: This phase I/II open-label, dose-finding, multi-center study will assess safety and primary efficacy of Onureg and Venetoclax combination, to define the optimal biological dose and optimal treatment duration of Onureg to be used along with Venetoclax for further studies in previously untreated patients with higher-risk myelodysplastic syndromes (HR-MDS) not eligible to transplant.

lead_sponsor: Groupe Francophone des Myelodysplasies

collaborators:
Bristol-Myers Squibb
AbbVie

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Bristol-Myers Squibb
AbbVie

location_facility:
Hôpital Avicenne
Hôpital Brabois
Hôpital Archet 1
CHU de Poitiers
CH Lyon sud
IUCT Oncopole
CHU d'Angers
CHU d'Amiens Picardie - Site sud
CH Annecy Genevois
CH Le Mans
Hôpital Cochin
CHU de Grenoble
CHU de Haut-Lévèque
Institut Paoli Calmettes
CHU de Tours - Hôpital Bretonneau
CHU de Limoges - Hôpital Dupuytren
Hôpital Saint Louis
CHU Hôtel Dieu
Centre Henri Becquerel


title: A Non-comparative Randomized Phase II Trial Evaluating the Combination of Paclitaxel-bevacizumab ± Atezolizumab in Patients With Advanced Non-squamous NSCLC Progressing After Immunotherapy and Chemotherapy

acronym: ADAPTABLE

summary: This is an open-label, randomized, non-comparative, multicentre, phase II study in which NSCLC patients who have progressed following chemotherapy and immunoptherapy are randomized to receive treatment with either paclitaxel and bevacizumab (Arm A), or paclitaxel, bevacizumab and atezolizumab (Arm B). An estimated 156 patients (52 in Arm A, 104 in Arm B) will be enrolled at approximately 40 centres. Patients will be treated until disease progression, unacceptable toxicity, withdrawal of consent or another discontinuation criterion is met. For patients in Arm B, continuation of atezolizumab beyond progression is permitted, at the investigator's discretion, if there is evidence of continued clinical benefit. The null hypothesis is progression free survival at 6 months ≤ 50% for Arm B, which is considered not sufficiently clinically meaningful to warrant further study. The alternative hypothesis is that 66% or more of patients in Arm B would achieve progression free survival at 6 months.

location_facility: Groupe Hospitalier Paris Saint Joseph GHPSJ

location_facility: Centre Hospitalier Intercommunal Créteil CHIC

location_facility: Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg


title: Phase II Study With Safety run-in of Azacitidine (AZA) Combined With Venetoclax (VEN) in Patients With Higher-risk Chronic Myelomonocytic Leukemia (CMML)

acronym: AVENHIR

summary: Open-label phase II, single arm, multicenter study with safety run-in to evaluate the efficacy and safety of Azacitidine combined with Venetoclax in patients with higher-risk chronic myelomonocytic leukemia

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
AbbVie

location_facility:
Hôpital Avicenne
Hôpital Archet 1
CHU de Poitiers
Hôpital privé du Confluent SAS
CHU d'Amiens
IUCT oncopole
CHU d'Angers
Institut Gustave Roussy
Hôpital Cochin
Centre hospitalier Lyon sud
Hôpital Pontchaillou
CHU de Grenoble
Institut Paoli Calmettes
CHRU de Limoges
CHU de Tours - Hôpital Bretonneau
Hôpital Saint Louis
CHU de Montpellier - Hôpital Saint Eloi
CHU Hôtel Dieu
Centre Henri Becquerel


title: Validation of the SLEDAI-P Self-questionnaire Completed by the Patient to Measure the Activity of the Systemic Lupus

acronym: OPTIMISE

summary: Validation of a self-questionnaire (SLEDAI-P/LUPIN) completed by the patient to measure the activity of the systemic lupus, in order to improve the patient's empowerment.

ReferenceCitation: Arnaud L, Fagot JP, Mathian A, Paita M, Fagot-Campagna A, Amoura Z. Prevalence and incidence of systemic lupus erythematosus in France: a 2010 nation-wide population-based study. Autoimmun Rev. 2014 Nov;13(11):1082-9. doi: 10.1016/j.autrev.2014.08.034. Epub 2014 Aug 27.

ReferenceCitation: Stoll T, Sutcliffe N, Mach J, Klaghofer R, Isenberg DA. Analysis of the relationship between disease activity and damage in patients with systemic lupus erythematosus--a 5-yr prospective study. Rheumatology (Oxford). 2004 Aug;43(8):1039-44. doi: 10.1093/rheumatology/keh238. Epub 2004 May 25.

ReferenceCitation: Wang C, Mayo NE, Fortin PR. The relationship between health related quality of life and disease activity and damage in systemic lupus erythematosus. J Rheumatol. 2001 Mar;28(3):525-32.

ReferenceCitation: Scherlinger M, Zein N, Gottenberg JE, Riviere M, Kleinmann JF, Sibilia J, Arnaud L. Difficulties and Psychological Impact of the SARS-CoV-2 Pandemic in Patients with Systemic Lupus Erythematosus: A Nationwide Patient Association Study. Healthcare (Basel). 2022 Feb 9;10(2):330. doi: 10.3390/healthcare10020330.

ReferenceCitation: Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, Utset TO, Gordon C, Isenberg DA, Hsieh HJ, Zhang D, Brunetta PG. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum. 2010 Jan;62(1):222-33. doi: 10.1002/art.27233.

ReferenceCitation: Stone JH. BLISS! Lupus learns its lessons. Lancet. 2011 Feb 26;377(9767):693-4. doi: 10.1016/S0140-6736(10)61546-2. Epub 2011 Feb 4. No abstract available.

ReferenceCitation: Luijten KM, Tekstra J, Bijlsma JW, Bijl M. The Systemic Lupus Erythematosus Responder Index (SRI); a new SLE disease activity assessment. Autoimmun Rev. 2012 Mar;11(5):326-9. doi: 10.1016/j.autrev.2011.06.011. Epub 2011 Sep 18.

ReferenceCitation: Symmons DP, Coppock JS, Bacon PA, Bresnihan B, Isenberg DA, Maddison P, McHugh N, Snaith ML, Zoma AS. Development and assessment of a computerized index of clinical disease activity in systemic lupus erythematosus. Members of the British Isles Lupus Assessment Group (BILAG). Q J Med. 1988 Nov;69(259):927-37.

ReferenceCitation: Isenberg DA, Garton M, Reichlin MW, Reichlin M. Long-term follow-up of autoantibody profiles in black female lupus patients and clinical comparison with Caucasian and Asian patients. Br J Rheumatol. 1997 Feb;36(2):229-33. doi: 10.1093/rheumatology/36.2.229.

ReferenceCitation: Ravirajan CT, Rowse L, MacGowan JR, Isenberg DA. An analysis of clinical disease activity and nephritis-associated serum autoantibody profiles in patients with systemic lupus erythematosus: a cross-sectional study. Rheumatology (Oxford). 2001 Dec;40(12):1405-12. doi: 10.1093/rheumatology/40.12.1405.

ReferenceCitation: Ehrenstein MR, Conroy SE, Heath J, Latchman DS, Isenberg DA. The occurrence, nature and distribution of flares in a cohort of patients with systemic lupus erythematosus: a rheumatological view. Br J Rheumatol. 1995 Mar;34(3):257-60. doi: 10.1093/rheumatology/34.3.257.

ReferenceCitation: Gordon C, Sutcliffe N, Skan J, Stoll T, Isenberg DA. Definition and treatment of lupus flares measured by the BILAG index. Rheumatology (Oxford). 2003 Nov;42(11):1372-9. doi: 10.1093/rheumatology/keg382. Epub 2003 Jun 16.

ReferenceCitation: Ceccarelli F, Perricone C, Massaro L, Cipriano E, Alessandri C, Spinelli FR, Valesini G, Conti F. Assessment of disease activity in Systemic Lupus Erythematosus: Lights and shadows. Autoimmun Rev. 2015 Jul;14(7):601-8. doi: 10.1016/j.autrev.2015.02.008. Epub 2015 Mar 2.

ReferenceCitation: Isenberg DA, Rahman A, Allen E, Farewell V, Akil M, Bruce IN, D'Cruz D, Griffiths B, Khamashta M, Maddison P, McHugh N, Snaith M, Teh LS, Yee CS, Zoma A, Gordon C. BILAG 2004. Development and initial validation of an updated version of the British Isles Lupus Assessment Group's disease activity index for patients with systemic lupus erythematosus. Rheumatology (Oxford). 2005 Jul;44(7):902-6. doi: 10.1093/rheumatology/keh624. Epub 2005 Apr 6.

ReferenceCitation: Gladman D, Urowitz M, Fortin P, Isenberg D, Goldsmith C, Gordon C, Petri M. Systemic Lupus International Collaborating Clinics conference on assessment of lupus flare and quality of life measures in SLE. Systemic Lupus International Collaborating Clinics Group. J Rheumatol. 1996 Nov;23(11):1953-5. No abstract available.

ReferenceCitation: Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.

ReferenceCitation: Mosca M, Tani C, Aringer M, Bombardieri S, Boumpas D, Brey R, Cervera R, Doria A, Jayne D, Khamashta MA, Kuhn A, Gordon C, Petri M, Rekvig OP, Schneider M, Sherer Y, Shoenfeld Y, Smolen JS, Talarico R, Tincani A, van Vollenhoven RF, Ward MM, Werth VP, Carmona L. European League Against Rheumatism recommendations for monitoring patients with systemic lupus erythematosus in clinical practice and in observational studies. Ann Rheum Dis. 2010 Jul;69(7):1269-74. doi: 10.1136/ard.2009.117200. Epub 2009 Nov 5.

ReferenceCitation: van Vollenhoven RF, Mosca M, Bertsias G, Isenberg D, Kuhn A, Lerstrom K, Aringer M, Bootsma H, Boumpas D, Bruce IN, Cervera R, Clarke A, Costedoat-Chalumeau N, Czirjak L, Derksen R, Dorner T, Gordon C, Graninger W, Houssiau F, Inanc M, Jacobsen S, Jayne D, Jedryka-Goral A, Levitsky A, Levy R, Mariette X, Morand E, Navarra S, Neumann I, Rahman A, Rovensky J, Smolen J, Vasconcelos C, Voskuyl A, Voss A, Zakharova H, Zoma A, Schneider M. Treat-to-target in systemic lupus erythematosus: recommendations from an international task force. Ann Rheum Dis. 2014 Jun;73(6):958-67. doi: 10.1136/annrheumdis-2013-205139. Epub 2014 Apr 16.

ReferenceCitation: Agmon-Levin N, Mosca M, Petri M, Shoenfeld Y. Systemic lupus erythematosus one disease or many? Autoimmun Rev. 2012 Jun;11(8):593-5. doi: 10.1016/j.autrev.2011.10.020. Epub 2011 Oct 25.

ReferenceCitation: Cervera R, Doria A, Amoura Z, Khamashta M, Schneider M, Guillemin F, Maurel F, Garofano A, Roset M, Perna A, Murray M, Schmitt C, Boucot I. Patterns of systemic lupus erythematosus expression in Europe. Autoimmun Rev. 2014 Jun;13(6):621-9. doi: 10.1016/j.autrev.2013.11.007. Epub 2014 Jan 10.

lead_sponsor: Association Francaise du Lupus et Autres Maladies Auto-immunes (AFL+)

location_facility: Hôpital Tenon - Service de dermatologie, médecine vasculaire et allergologie

location_facility: Hôpital Saint-Louis - Service de Médecine Interne, Maladies Systémiques

location_facility: Service de médecine interne CHU de Poitiers

location_facility: CHU de Nantes Hôtel Dieu- Centre de compétences maladies systémiques et auto-immunes rares

location_facility: Hôpital civil - Immunologie Clinique et Médecine Interne

location_facility: Service de médecine interne et immunologie clinique CHU de Nancy - Hôpitaux de Brabois

location_facility: CHU Dijon Bourgogne - Hôpital François Mitterrand

location_facility: Service de Médecine Interne & Immunologie Clinique Hôpital Bretonneau CHRU de Tours

location_facility: Service de Médecine Interne Hôpital Robert Schuman

location_facility: Hôpital Bicêtre - Service de Rhumatologie

location_facility: Service de Médecine interne et maladies infectieuses (Sud) CHU de Bordeaux-GH Sud - Hôpital Haut-Lévêque

location_facility: Et service de médecine interne - CHU Réunion site Nord, St Denis

location_facility: Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix

location_facility: Département de Médecine Interne du Pr.BENHAMOU CHU DE ROUEN


title: A Prospective Randomized Trial of Non-inferiority Comparing RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis

acronym: TRIO

summary:
The goal of this randomized clinical trial is to compare relapse remitting multiple sclerosis (RRMS) patients treated by ocrelizumab or by rituximab followed for 2 years. The main question it aims to answer is : • to demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the % of patients without disease activity at 2 years.

During the 2 years, the study includes 6 follow-up visits and the completion of various health and quality of life questionnaires. The protocol visits follow the usual schedule of treatment infusions for the disease (at initiation of treatment, 15 days after, and then every 6 months).

Two comparison groups: Researchers will compare rituximab treated patients versus ocrelizumab treated patients to see the % of patients without disease activity at 2 years.

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille

location_facility: CHRU de Brest - Hôpital la Cavale Blanche

location_facility: Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer

location_facility: Groupe Hospitalier Universitaire Henri Mondor

location_facility: CHU de Toulouse - Bâtiment Pierre Paul Riquet

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: CHRU de Montpellier - Hôpital Gui de Chauliac

location_facility: Centre Hospitalier de Pontoise - GHT NOVO


title: Modalities And Safety Of Cardiac Rehabilitation In A Population Managed For Spontaneous Hematoma Or Coronary Disruption (DISCO): Data From The DISCO Study

acronym: READAPT-DISCO

summary:
Spontaneous Coronary Artery Dissection (SCAD) is a rare and often misdiagnosed cause of Acute Coronary Syndrome (ACS) affecting predominantly young women without cardiovascular risk factors. There is no definitive evidence on the optimal management of SCAD, but the general approach is conservative.

Unlike established evidence-based rehabilitation programs for ACS and heart failure, no cardiac rehabilitation protocol exists for SCAD.

The aim of the study is to report and detail the cardiac rehabilitation program which was proposed to patients previously included in The Study of the Prevalence Fibromuscular Dysplasia in Patient With Haematoma or Spontaneous Coronary Artery Dissection. (DISCO trial - NCT02799186).

time_perspective: Retrospective

ReferenceCitation: Combaret N, Gerbaud E, Derimay F, Souteyrand G, Cassagnes L, Bouajila S, Berrandou T, Range G, Meneveau N, Harbaoui B, Lattuca B, Bouatia-Naji N, Motreff P. National French registry of spontaneous coronary artery dissections: prevalence of fibromuscular dysplasia and genetic analyses. EuroIntervention. 2021 Aug 27;17(6):508-515. doi: 10.4244/EIJ-D-20-01046.

ReferenceCitation: Combaret N, Liabot Q, Deiri M, Lhermusier T, Boiffard E, Filippi E, Roule V, Georges JL, Manzo-Silberman S, Fluttaz A, Marliere S, Souteyrand G, Pereira B, Cassagnes L, Motreff P. Characteristics and Prognosis of Patients With Fibromuscular Dysplasia in a Population of Spontaneous Coronary Artery Dissections (from the French Registry of Spontaneous Coronary Artery Dissections "DISCO"). Am J Cardiol. 2022 Jul 15;175:38-43. doi: 10.1016/j.amjcard.2022.04.007. Epub 2022 May 11.

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Hôpital Universitaire de la Pitié-Salpêtrière

location_facility: Hôpital de la Croix Rousse - hospices civils de Lyon

location_facility: GHR Mulhouse et Sud Alsace - Hôpital Emile Muller

location_facility: Hôpital Louis Pradel - Hospices civils de Lyon


title: Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension IN Patients With Moderate to Severe Chronic Kidney Disease: an Open Label, a Cluster Randomized Controlled, Phase 3 Trial

acronym: THINK

summary: Chronic kidney disease (CKD) is a major public health issue worldwide. Hypertension is the first risk factor in patients with CKD for mortality, cardiovascular disease and end-stage renal disease. It's now well established that lowering blood pressure (BP) reduces renal and cardiovascular complications in this high-risk population. In the general population, in addition to lifestyle interventions, the strategy to initiate and escalate a BP-lowering drug treatment is well described. The drug therapies recommended to achieve optimal BP control in the general population are the following: blockers of the renin-angiotensin system (angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB)), diuretics (thiazides and thiazide-like diuretics), and calcium channel blockers. For patients with CKD, the guidelines advise to start the BP-lowering agent with ACEi or ARB, but then, there is no strong evidence to support the preferential use of any particular agent in controlling BP and the results of clinical trials are discordant. In the NephroTest cohort, a French cohort of patients with CKD stage 1 to 5, among 2015 patients, 1782 had hypertension, only 54% had a diuretic and 44% had uncontrolled hypertension. In this cohort, extracellular fluid (ECF) overload was an independent determinant of hypertension, uncontrolled hypertension and apparent treatment resistant hypertension. In the same cohort, ECF overload was independently associated with end-stage kidney disease and death. Our hypothesis is that patients with CKD and uncontrolled hypertension are fluid overloaded and that the second line of treatment after an ACEi or an ARB should be a diuretic. We hypothesize that a specific algorithm to lower BP in patients with moderate to severe CKD based on diuretics will be more effective in term of cardiovascular event, mortality and evolution to end-stage kidney disease as compared to standard of care.

lead_sponsor: University Hospital, Tours

location_facility: Department of Nephrology, University Hospital of Lyon

location_facility: Department of Nephrology, Hospital of Chartres

location_facility: Department of Nephrology, Hospital of Colmar

location_facility: Department of Nephrology, University Hospital of Nancy

location_facility: Department of Nephrology, Régional Hospital of Mulhouse

location_facility: Department of Nephrology, University Hospital of Marseille

location_facility: Department of Nephrology, University Hospital of Rennes

location_facility: Department of Nephrology, Hospital of Haguenau

location_facility: Department of Nephrology, University Hospital of Saint Etienne

location_facility: Department of Nephrology, University Hospital of Rouen

location_facility: Department of Nephrology, University Hospital of Reims

location_facility: Department of Nephrology, University Hospital of Nantes

location_facility: Department of Nephrology, Departemental Hospital of Vendée

location_facility: Department of Nephrology, Regional Hospital of Metz

location_facility: Department of Nephrology, European Hospital Georges Pompidou, AP-HP

location_facility: Department of Nephrology, University Hospital of Angers

location_facility: Department of Nephrology, Bichat Hospital, AP-HP

location_facility: Department of Nephrology, University Hospital of Clermont-Ferrand

location_facility: Department of Nephrology, Hospital of Le Puy en Velay

location_facility: Department of Nephrology, Hospital of Perpignan

location_facility: Department of Nephrology, Tenon Hospital, AP-HP

location_facility: Department of Nephrology, Necker Hospital, AP-HP

location_facility: Department of Nephrology, Hospital of Valenciennes

location_facility: Department of Nephrology, University Hospital of Grenoble

location_facility: Department of Nephrology, Hospital of Roubaix

location_facility: Department of Nephrology, Hospital of Saint Malo

location_facility: Department of Nephrology, University Hospital of Limoges

location_facility: Department of Nephrology, Hospital of Chalon-sur-Saône

location_facility: Department of Nephrology, University Hospital of Tours

location_facility: Department of Nephrology, University Hospital of Bordeaux

location_facility: Department of Nephrology, University Hospital of Nîmes

location_facility: Department of Nephrology, University Hospital of Brest


title: Randomized Medical-Economic Trial Comparing Focal HIFU Treatment to Total Prostatectomy in Patients With Intermediate Prognosis Prostate Cancer

acronym: EMERHIT

summary: Medico-Economic Randomized Trial comparing Focal HIFU Treatment to Radical Prostatectomy in Patients with Favorable Intermediate Risk Prostate Cancer

location_facility:
Clinique Saint Michel
Institut Mutualiste Montsouris
CHU de Rennes
Hopital Lyon Sud HCL Bat 3C Centre
Hopitaux civil de Colmar
APHM Nord Marseille
Hopital Privé La Louviere
Hopital Cochin
Clinique La Croix du Sud
Hopital Edouard Herriot Pavillon V
Clinique Oceane
Hopital Privé francheville
Hopital Americain de Paris
CHU Toulouse rangueil
CHU de Bordeaux
Hopital prive drome ardeche
Polyclinique beaujolais
Clinique Tivoli
Clinique Saint Vincent
Hopital Claude HURIEZ


title: Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit. Multicentric Non-inferiority Randomised Controlled Trial

acronym: COTRIVAP

summary: Efficacy of cotrimoxazole as a de-escalation treatment for adult patients Ventilator-Associated Pneumonia in intensive care unit Multicentre randomized non-inferiority trial comparing cotrimoxazole to standard antibiotic therapy for enterobacterial VAP

status: Active, not recruiting

location_facility: Réanimation Médico-chirurgicale - Hôpital Avicenne

location_facility: Réanimation Médicale et Maladies Infectieuses - Hôpital Laennec

location_facility: Réanimation Polyvalente - Hôpital Sainte Musse

location_facility: Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière

location_facility: Médecine Intensive Réanimation - Centre Hospitalier Universitaire Angers

location_facility: Médecine Intensive Réanimation - CHU Bordeaux - Hôpital Pellegrin

location_facility: Réanimation Médicale - Hôpital Robert Salengro

location_facility: Médecine Intensive Réanimation - Hôpital Bretonneau

location_facility: Médecine Intensive Réanimation - CHRU de Nancy - Hôpitaux de Brabois

location_facility: Centre Hospitalier Intercommunal Saint-Germain-en-Laye

location_facility: Réanimation Polyvalente - Centre Hospitalier Universitaire Nord Saint-Etienne

location_facility: Réanimation polyvalente et Unité de surveillance continue - Centre Hospitalier de Cholet

location_facility: Médecine Intensive Réanimation - Centre Hospitalier Universitaire Amiens-Picardie

location_facility: Médecin Intensive Réanimation - Hôpital Delafontaine

location_facility: Réanimation Polyvalente - Centre Hospitalier Annecy Genevois

location_facility: Médecine Intensive Réanimation - Centre Hospitalier Béthune - Beuvry

location_facility: Réanimation polyvalente et surveillance continus - Centre Hospitalier Sud Francilien

location_facility: Réanimation Médicale - Centre Jean Perrin - Site Gabriel Montpied

location_facility: Réanimation Médicale - Hôpital Européen Georges Pompidou

location_facility: Médecine Intensive Réanimation - Centre Hospitalier Départemental Vendée

location_facility: Médecine Intensive Réanimation - Hôpital Michallon

location_facility: Réanimation Médico-chirurgicale - Hôpital Ambroise-Paré

location_facility: Réanimation et Surveillance continue - Centre Hospitalier de Melun

location_facility: Réanimation médicale - Centre Hospitalier de Longjumeau

location_facility: Médecine Intensive Réanimation - Centre Hospitalier Léon Binet

location_facility: Médecine Intensive Réanimation - Hôpital François Mitterrand

location_facility: Médecine Intensive Réanimation - Hôpital Louis Mourier

location_facility: Médecine Intensive Réanimation - Hôpital René Dubos

location_facility: Réanimation Médicale - Hôpital de la Pitié Salpêtrière

location_facility: Médecine Intensive Réanimation - Nouvel Hôpital Civil


title: Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis

acronym: BICCS

summary: Patients hospitalized in ICU with sepsis (infection with life-threatening organ dysfunction according to sepsis 3.0 definitions) or septic shock presumably due to MDR-GNB (multidrug resistant Gram-negative bacteria). The study will be a prospective multicentre, randomized, open-label comparative continuous vs. intermittent pivotal βL (Beta Lactamine) antibiotic infusion strategies and combination vs. monotherapy trial conducted with a 2X2 factorial design.

location_facility: Réanimation polyvalente - CHR Metz-Thionville - Hôpital de Mercy

location_facility: Médecine intensive - réanimation - HCL - Edouard Herriot

location_facility: Réanimation polyvalente/Surveillance continue - CH Sud Essonne-Etampes

location_facility: Réanimation polyvalente - CH d'Argenteuil - Hôpital Victor Dupuy

location_facility: Médecine intensive - réanimation - CHU Bordeaux - Hôpital Pellegrin

location_facility: Médecine intensive - réanimation - CHU Amiens-Picardie

location_facility: Réanimation Médico Chirurgicale & USC - CH Le Mans

location_facility: Réanimation polyvalente - CH de Versailles - Hôpital André Mignot

location_facility: Médecine intensive - réanimation-Centre Hospitalier Départemental Vendée

location_facility: Médecine intensive et réanimation polyvalente 6 CHU de Reims - Hôpital Robert Debré

location_facility: Médecine intensive et réanimation infectieuse - Bichat

location_facility: Anesthésie - Réanimation - CHU Poitiers - Site de la Milétrie

location_facility: Médecine intensive - réanimation - CHU Grenoble-Alpes Hôpital Michallon

location_facility: Médecine intensive - réanimation - CHU Gabriel Montpied

location_facility: Médecine intensive - réanimation - CHU Poitiers - Site de la Milétrie

location_facility: Médecine intensive - réanimation - CHU de Strasbourg - Nouvel Hôpital Civil

location_facility: Médecine intensive - réanimation - CHU Montpellier - Hôpital Lapeyronie

location_facility: Médecine intensive - réanimation - CHU Nice - Hôpital Archet

location_facility: Médecine intensive - réanimation - Ambroise Paré

location_facility: Réanimation et soins continus - CH Béthune - Beuvry

location_facility: Médecine intensive - réanimation-CH St Denis - Hôpital Delafontaine


title: Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Randomized Controlled Trial

summary: Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is associated with a poor prognosis, with a 3-month mortality rate of over 50%. To date, no treatment has been proven to be effective in AI-FPI. The interest of glucocorticoids is controversial and needs to be confirmed. This confirmation is mandatory to validate the improvement of the prognosis of EA-IPF under this treatment but also to search for unsuspected deleterious effects as it has been shown with immunosuppressants in stable idiopathic pulmonary fibrosis.

ReferenceCitation: Naccache JM, Montil M, Cadranel J, Cachanado M, Cottin V, Crestani B, Valeyre D, Wallaert B, Simon T, Nunes H. Study protocol: exploring the efficacy of cyclophosphamide added to corticosteroids for treating acute exacerbation of idiopathic pulmonary fibrosis; a randomized double-blind, placebo-controlled, multi-center phase III trial (EXAFIP). BMC Pulm Med. 2019 Apr 11;19(1):75. doi: 10.1186/s12890-019-0830-x.

oa_colors: green gold

evidence: oa journal (via doaj)

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Naccache JM, Jouneau S, Didier M, Borie R, Cachanado M, Bourdin A, Reynaud-Gaubert M, Bonniaud P, Israel-Biet D, Prevot G, Hirschi S, Lebargy F, Marchand-Adam S, Bautin N, Traclet J, Gomez E, Leroy S, Gagnadoux F, Riviere F, Bergot E, Gondouin A, Blanchard E, Parrot A, Blanc FX, Chabrol A, Dominique S, Gibelin A, Tazi A, Berard L, Brillet PY, Debray MP, Rousseau A, Kerjouan M, Freynet O, Dombret MC, Gamez AS, Nieves A, Beltramo G, Pastre J, Le Borgne-Krams A, Degot T, Launois C, Plantier L, Wemeau-Stervinou L, Cadranel J, Chenivesse C, Valeyre D, Crestani B, Cottin V, Simon T, Nunes H; EXAFIP investigators and the OrphaLung network. Cyclophosphamide added to glucocorticoids in acute exacerbation of idiopathic pulmonary fibrosis (EXAFIP): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2022 Jan;10(1):26-34. doi: 10.1016/S2213-2600(21)00354-4. Epub 2021 Sep 7.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

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

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

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

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

repositories_concat: HAL

ReferenceCitation: Raghu G, Remy-Jardin M, Myers JL, Richeldi L, Ryerson CJ, Lederer DJ, Behr J, Cottin V, Danoff SK, Morell F, Flaherty KR, Wells A, Martinez FJ, Azuma A, Bice TJ, Bouros D, Brown KK, Collard HR, Duggal A, Galvin L, Inoue Y, Jenkins RG, Johkoh T, Kazerooni EA, Kitaichi M, Knight SL, Mansour G, Nicholson AG, Pipavath SNJ, Buendia-Roldan I, Selman M, Travis WD, Walsh S, Wilson KC; American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Society. Diagnosis of Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am J Respir Crit Care Med. 2018 Sep 1;198(5):e44-e68. doi: 10.1164/rccm.201807-1255ST.

ReferenceCitation: Collard HR, Ryerson CJ, Corte TJ, Jenkins G, Kondoh Y, Lederer DJ, Lee JS, Maher TM, Wells AU, Antoniou KM, Behr J, Brown KK, Cottin V, Flaherty KR, Fukuoka J, Hansell DM, Johkoh T, Kaminski N, Kim DS, Kolb M, Lynch DA, Myers JL, Raghu G, Richeldi L, Taniguchi H, Martinez FJ. Acute Exacerbation of Idiopathic Pulmonary Fibrosis. An International Working Group Report. Am J Respir Crit Care Med. 2016 Aug 1;194(3):265-75. doi: 10.1164/rccm.201604-0801CI.

ReferenceCitation: Kondoh Y, Azuma A, Inoue Y, Ogura T, Sakamoto S, Tsushima K, Johkoh T, Fujimoto K, Ichikado K, Matsuzawa Y, Saito T, Kishi K, Tomii K, Sakamoto N, Aoshima M, Araya J, Izumi S, Arita M, Abe M, Yamauchi H, Shindoh J, Suda T, Okamoto M, Ebina M, Yamada Y, Tohda Y, Kawamura T, Taguchi Y, Ishii H, Hashimoto N, Abe S, Taniguchi H, Tagawa J, Bessho K, Yamamori N, Homma S. Thrombomodulin Alfa for Acute Exacerbation of Idiopathic Pulmonary Fibrosis. A Randomized, Double-Blind Placebo-controlled Trial. Am J Respir Crit Care Med. 2020 May 1;201(9):1110-1119. doi: 10.1164/rccm.201909-1818OC.

ReferenceCitation: Papiris SA, Kagouridis K, Kolilekas L, Papaioannou AI, Roussou A, Triantafillidou C, Baou K, Malagari K, Argentos S, Kotanidou A, Karakatsani A, Manali ED. Survival in Idiopathic pulmonary fibrosis acute exacerbations: the non-steroid approach. BMC Pulm Med. 2015 Dec 14;15:162. doi: 10.1186/s12890-015-0146-4.

ReferenceCitation: Farrand E, Vittinghoff E, Ley B, Butte AJ, Collard HR. Corticosteroid use is not associated with improved outcomes in acute exacerbation of IPF. Respirology. 2020 Jun;25(6):629-635. doi: 10.1111/resp.13753. Epub 2019 Dec 17. Erratum In: Respirology. 2022 Oct;27(10):905.

ReferenceCitation: Nalysnyk L, Cid-Ruzafa J, Rotella P, Esser D. Incidence and prevalence of idiopathic pulmonary fibrosis: review of the literature. Eur Respir Rev. 2012 Dec 1;21(126):355-61. doi: 10.1183/09059180.00002512.

ReferenceCitation: Duchemann B, Annesi-Maesano I, Jacobe de Naurois C, Sanyal S, Brillet PY, Brauner M, Kambouchner M, Huynh S, Naccache JM, Borie R, Piquet J, Mekinian A, Virally J, Uzunhan Y, Cadranel J, Crestani B, Fain O, Lhote F, Dhote R, Saidenberg-Kermanac'h N, Rosental PA, Valeyre D, Nunes H. Prevalence and incidence of interstitial lung diseases in a multi-ethnic county of Greater Paris. Eur Respir J. 2017 Aug 3;50(2):1602419. doi: 10.1183/13993003.02419-2016. Print 2017 Aug.

ReferenceCitation: Cottin V, Crestani B, Cadranel J, Cordier JF, Marchand-Adam S, Prevot G, Wallaert B, Bergot E, Camus P, Dalphin JC, Dromer C, Gomez E, Israel-Biet D, Jouneau S, Kessler R, Marquette CH, Reynaud-Gaubert M, Aguilaniu B, Bonnet D, Carre P, Danel C, Faivre JB, Ferretti G, Just N, Lebargy F, Philippe B, Terrioux P, Thivolet-Bejui F, Trumbic B, Valeyre D. French practical guidelines for the diagnosis and management of idiopathic pulmonary fibrosis - 2017 update. Full-length version. Rev Mal Respir. 2017 Oct;34(8):900-968. doi: 10.1016/j.rmr.2017.07.017. Epub 2017 Sep 20. No abstract available.

ReferenceCitation: Idiopathic Pulmonary Fibrosis Clinical Research Network; Raghu G, Anstrom KJ, King TE Jr, Lasky JA, Martinez FJ. Prednisone, azathioprine, and N-acetylcysteine for pulmonary fibrosis. N Engl J Med. 2012 May 24;366(21):1968-77. doi: 10.1056/NEJMoa1113354. Epub 2012 May 20.

ReferenceCitation: Collard HR, Moore BB, Flaherty KR, Brown KK, Kaner RJ, King TE Jr, Lasky JA, Loyd JE, Noth I, Olman MA, Raghu G, Roman J, Ryu JH, Zisman DA, Hunninghake GW, Colby TV, Egan JJ, Hansell DM, Johkoh T, Kaminski N, Kim DS, Kondoh Y, Lynch DA, Muller-Quernheim J, Myers JL, Nicholson AG, Selman M, Toews GB, Wells AU, Martinez FJ; Idiopathic Pulmonary Fibrosis Clinical Research Network Investigators. Acute exacerbations of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2007 Oct 1;176(7):636-43. doi: 10.1164/rccm.200703-463PP. Epub 2007 Jun 21.

ReferenceCitation: Collard HR, Yow E, Richeldi L, Anstrom KJ, Glazer C; IPFnet investigators. Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials. Respir Res. 2013 Jul 13;14(1):73. doi: 10.1186/1465-9921-14-73.

ReferenceCitation: Churg A, Muller NL, Silva CI, Wright JL. Acute exacerbation (acute lung injury of unknown cause) in UIP and other forms of fibrotic interstitial pneumonias. Am J Surg Pathol. 2007 Feb;31(2):277-84. doi: 10.1097/01.pas.0000213341.70852.9d.

ReferenceCitation: Parambil JG, Myers JL, Ryu JH. Histopathologic features and outcome of patients with acute exacerbation of idiopathic pulmonary fibrosis undergoing surgical lung biopsy. Chest. 2005 Nov;128(5):3310-5. doi: 10.1378/chest.128.5.3310.

ReferenceCitation: Oda K, Ishimoto H, Yamada S, Kushima H, Ishii H, Imanaga T, Harada T, Ishimatsu Y, Matsumoto N, Naito K, Yatera K, Nakazato M, Kadota J, Watanabe K, Kohno S, Mukae H. Autopsy analyses in acute exacerbation of idiopathic pulmonary fibrosis. Respir Res. 2014 Sep 1;15(1):109. doi: 10.1186/s12931-014-0109-y.

ReferenceCitation: Dotan Y, Vaidy A, Shapiro WB, Zhao H, Dass C, Toyoda Y, Marchetti N, Shenoy K, Cordova FC, Criner GJ, Mamary AJ. Effect of Acute Exacerbation of Idiopathic Pulmonary Fibrosis on Lung Transplantation Outcome. Chest. 2018 Oct;154(4):818-826. doi: 10.1016/j.chest.2018.06.027. Epub 2018 Jun 30.

ReferenceCitation: Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.

ReferenceCitation: Kreuter M, Polke M, Walsh SLF, Krisam J, Collard HR, Chaudhuri N, Avdeev S, Behr J, Calligaro G, Corte T, Flaherty K, Funke-Chambour M, Kolb M, Kondoh Y, Maher TM, Molina Molina M, Morais A, Moor CC, Morisset J, Pereira C, Quadrelli S, Selman M, Tzouvelekis A, Valenzuela C, Vancheri C, Vicens-Zygmunt V, Walscher J, Wuyts W, Wijsenbeek M, Cottin V, Bendstrup E. Acute exacerbation of idiopathic pulmonary fibrosis: international survey and call for harmonisation. Eur Respir J. 2020 Apr 3;55(4):1901760. doi: 10.1183/13993003.01760-2019. Print 2020 Apr.

ReferenceCitation: Molyneaux PL, Cox MJ, Willis-Owen SA, Mallia P, Russell KE, Russell AM, Murphy E, Johnston SL, Schwartz DA, Wells AU, Cookson WO, Maher TM, Moffatt MF. The role of bacteria in the pathogenesis and progression of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2014 Oct 15;190(8):906-13. doi: 10.1164/rccm.201403-0541OC.

ReferenceCitation: O'Dwyer DN, Ashley SL, Gurczynski SJ, Xia M, Wilke C, Falkowski NR, Norman KC, Arnold KB, Huffnagle GB, Salisbury ML, Han MK, Flaherty KR, White ES, Martinez FJ, Erb-Downward JR, Murray S, Moore BB, Dickson RP. Lung Microbiota Contribute to Pulmonary Inflammation and Disease Progression in Pulmonary Fibrosis. Am J Respir Crit Care Med. 2019 May 1;199(9):1127-1138. doi: 10.1164/rccm.201809-1650OC.

ReferenceCitation: Cottin V, Cadranel J, Crestani B, Dalphin JC, Delaval P, Israel-Biet D, Kessler R, Reynaud-Gaubert M, Valeyre D, Wallaert B, Bouquillon B, Cordier JF. Management of idiopathic pulmonary fibrosis in France: a survey of 1244 pulmonologists. Respir Med. 2014 Jan;108(1):195-202. doi: 10.1016/j.rmed.2013.11.017. Epub 2013 Dec 3.

ReferenceCitation: Shulgina L, Cahn AP, Chilvers ER, Parfrey H, Clark AB, Wilson EC, Twentyman OP, Davison AG, Curtin JJ, Crawford MB, Wilson AM. Treating idiopathic pulmonary fibrosis with the addition of co-trimoxazole: a randomised controlled trial. Thorax. 2013 Feb;68(2):155-62. doi: 10.1136/thoraxjnl-2012-202403. Epub 2012 Nov 10.

lead_sponsor: Fondation Hôpital Saint-Joseph

location_facility:
Hôpital Avicenne
Hôpital Européen Georges Pompidou
CHU Toulouse
CHU Nice
CHU Rennes
Hôpital Paris Saint-Joseph
CHU Tours
CHU BOrdeaux
Hôpital FOCH
Hôpital Saint-Louis
Hôpital Tenon
CHU de Dijon
Hôpital Bichat
Hôpital Kremiln Bicetre
CHU Rouen
CHU de Nantes
CHU Nancy
CHIC
CHU Reims
CHU Clermont-Ferrand
CHU de Besancon
CHRU Lille
Hôpital Nord
CHU de Montpellier
CHU Caen
CHU Strasbourg
CHU Grenoble
Hospices Civils de Lyon
CHU ANgers


title: Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis: a Non-inferiority Randomized Trial

acronym: MADULO

summary: The goal of this clinical trial is to compare a step-down strategy of spacing dupilumab injections with a standard maintenance treatment in adolescents and adults with controlled Atopic dermatitis (AD) for at least six months. The impact of dosage reduction strategies will be assessed with an innovative primary endpoint: the area under the curve of the weekly ADCT assessment.

location_facility: Groupement des Hôpitaux de l'institut Catholique de Lille


title: Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia

acronym: PROPLACO-Tel

summary: The goal of this clinical trial is to evaluate in real life, in patients with Hereditary Hemorrhagic Telangiectasia (HHT), the tolerance of the strategy of use of anticoagulant and/or antiplatelet, by comparing a new exposure period (first trimester of treatment) to a period of reference non-exposure (last trimester before start of treatment).

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Assistance Publique - Hôpitaux de Marseille


title: Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes in Nulliparous Women After Assisted Reproductive Technology. APPART

acronym: APPART

summary: This study seeks to validate the hypothesis that nulliparous pregnant women after Assisted Reproductive Technology (ART) are at high risk of preeclampsia and perinatal complications and represent a subgroup for which aspirin prophylaxis during pregnancy may be effective in the prevention of preterm preeclampsia and other perinatal adverse outcomes.

lead_sponsor: University Hospital, Toulouse

location_facility: HCL - Groupement Hospitalier Est, Hôpital Femme Mère Enfant


title: A ctDNA Screening Program in Patients With HR+, HER2- Metastatic Breast Cancer for Detection of High-risk Relapse Patients on Any CDK4/6 Inhibitor and a Randomised Phase II Study Comparing Alpelisib Combined With Fulvestrant to Ribociclib Combined With Fulvestrant, in Patients With Persistent Targetable PIK3CA Mutations

acronym: SAFIR 03

summary: After an initial screening phase (SAFIR 03 - SCREENING) to identify patients with blood circulating mutated-PIK3CA tumours persistent, patients will be enrolled in the treatment phase of SAFIR 03 (SAFIR 03 - ARRIBA) that was designed as a randomised, open-label, multicentre, phase II study, for comparison of alpelisib to ribociclib in combination with fulvestrant (as the continuation of the CDK4/6 inhibitor-fulvestrant strategy) in terms of progression-free survival (PFS).

lead_sponsor: UNICANCER

sponsor_collaborators:
UNICANCER
Novartis
Breast Cancer Research Foundation

location_facility: Centre Hospitalier de Versailles - Hôpital André Mignot

location_facility: Medipôle de Nancy - COG-ILC (Polyclinique de Gentilly)

location_facility: Sainte Catherine Institut du Cancer Avignon Provence

location_facility: Polyclinique de Limoges - Site François Chénieux

location_facility: CHP Saint-Grégoire - Groupe Vivalto Santé

location_facility: Groupe Hospitalier Mutualiste de Grenoble (GHMG)

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Clinique Pasteur Lanroze - CFRO - Groupe Vivalto Santé

location_facility: Hôpital Privé des Côtes-d'Armor (HPCA) - Cario


title: A Phase II Study of Durvalumab (MEDI 4736) Maintenance in Frail Limited Disease Small Cell Lung Cancer Patients After Thoracic Chemoradiotherapy (CRT)

acronym: DURVALUNG

summary:
This study is an academic-lead, open-label, multicenter, randomized phase II trial for frail limited disease Small Cell Lung Cancer (LD-SCLC) patients.

Frail conditions are: Eastern Cooperative Oncology Group performance status (ECOG PS) 2 or ECOG PS 0-1 and older than 70 or ECOG PS 0-1 and did not receive a concomitant thoracic chemo-radiotherapy (CRT) because of comorbidities.

During the screening phase, patients complete either the standard concomitant thoracic CRT and cisplatin-etoposide regimen or a sequential CRT and carboplatin.

Patients showing a disease control (defined as stable disease [SD], partial response [PR], or complete response [CR] according to RECIST v1.1) at the radiological evaluation performed after the end of thoracic CRT can receive prophylactic cranial irradiation (PCI) as per local practice. They will then be randomized to receive durvalumab every 4 weeks (experimental arm A) or surveillance (control arm B) as per standard of care.

Thus, DURVALUNG study aims to evaluate the efficacy of durvalumab maintenance treatment in frail LD-SCLC patients who have not progressed following platinum-based concomitant or sequential CRT.

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.

sponsor_collaborators: UNICANCER AstraZeneca

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

location_facility: Institut régional du Cancer de Montpellier - ICM Val d'Aurelle

location_facility: Hopital Nord Ouest - Villefranche sur Saône

location_facility: Polyclinique de Limoges -Site Clinique Chénieux

location_facility: Institut de Cancérologie de l'Ouest - Site René Gauducheau


title: French Observational Study of Patients With Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma in Real-World Settings

acronym: FOLLOW

summary:
Chronic lymphocytic leukemia (CLL) is the most frequent form of leukemia in the Western World. The disease is characterized by the accumulation and proliferation of mature, monoclonal, CD5+ B-cells with specific immunophenotype in the peripheral blood (above 5x109/L), bone marrow and secondary lymphoid organs. Small lymphocytic leukemia (SLL) is characterized by similar tumor cells but without increased lymphocyte count. The management of these patients have considerably changed over the last decade. Indeed, beyond chemo-immunotherapy, multiple targeted therapies have been approved on the basis of phase 2 and randomized phase 3 clinical trials and have subsequently been used in daily practice. The management of patients with SLL is similar to that of those with CLL. In addition to therapeutic advances, the advent of new sequencing technologies has also identified CLL genetic features that are now being incorporated in patient routine evaluation.

We here propose to set a large-scale prospective and non-interventional study including patients with symptomatic CLL/SLL with the aim to evaluate the real-world clinical management of these patients and to identify the impact of treatments and therapeutic trajectories on long-term outcome.

lead_sponsor: French Innovative Leukemia Organisation

sponsor_collaborators:
French Innovative Leukemia Organisation
AbbVie
AstraZeneca
BeiGene
Janssen-Cilag Ltd.

location_facility: ROUEN - Centre Henri Becquerel - Service Hématologie Clinique

location_facility: ARGENTEUIL - Centre hospitalier Victor Dupouy

location_facility: BREST - Hôpital Morvan - Hématologie Clinique

location_facility: NANTES - Hôpital Hôtel Dieu - Hématologie Clinique

location_facility: BEZIERS - Centre Hospitalier - Hématologie

location_facility: RENNES - CHU Pontchaillou - Hématologie Clinique

location_facility: LILLE GHICL - Hôpital Saint Vincent de Paul

location_facility: PERPIGNAN - CH St Jean - Hématologie Clinique

location_facility: RENNES - Hôpital Pontchaillou - Hématologie

location_facility: Toulouse - IUCT Oncopole - Service d'Hématologie

location_facility: MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique

location_facility: APHP - Hôpital Pitié Salpêtrière - Hématologie

location_facility: ST ETIENNE - CHU et Institut De Cancérologie Lucien Neuwirth


title: Diagnostic Performance of General Practitioners in Compression Ultrasound for the Diagnosis of Proximal Deep Vein Thrombosis of the Lower Limbs

acronym: GPCUS

summary: The objective of this study is to evaluate the diagnostic efficiency of general practitioners for the diagnosis of proximal deep vein thrombosis of the lower limbs compared with whole-leg ultrasound with Doppler performed by the vascular physician.

ReferenceCitation: Mumoli N, Vitale J, Giorgi-Pierfranceschi M, Sabatini S, Tulino R, Cei M, Bucherini E, Bova C, Mastroiacovo D, Camaiti A, Palmiero G, Puccetti L, Dentali F; PRACTICUS Study Investigators. General Practitioner-Performed Compression Ultrasonography for Diagnosis of Deep Vein Thrombosis of the Leg: A Multicenter, Prospective Cohort Study. Ann Fam Med. 2017 Nov;15(6):535-539. doi: 10.1370/afm.2109.

ReferenceCitation: Mumoli N, Vitale J, Cocciolo M, Cei M, Brondi B, Basile V, Sabatini S, Gambaccini L, Carrara I, Camaiti A, Giuntoli S, Dentali F. Accuracy of nurse-performed compression ultrasonography in the diagnosis of proximal symptomatic deep vein thrombosis: a prospective cohort study. J Thromb Haemost. 2014 Apr;12(4):430-5. doi: 10.1111/jth.12522.

ReferenceCitation: Pomero F, Dentali F, Borretta V, Bonzini M, Melchio R, Douketis JD, Fenoglio LM. Accuracy of emergency physician-performed ultrasonography in the diagnosis of deep-vein thrombosis: a systematic review and meta-analysis. Thromb Haemost. 2013 Jan;109(1):137-45. doi: 10.1160/TH12-07-0473. Epub 2012 Nov 8.

ReferenceCitation: Lee JH, Lee SH, Yun SJ. Comparison of 2-point and 3-point point-of-care ultrasound techniques for deep vein thrombosis at the emergency department: A meta-analysis. Medicine (Baltimore). 2019 May;98(22):e15791. doi: 10.1097/MD.0000000000015791.

lead_sponsor: University Hospital, Caen

location_facility:
Condé sur vire
Paris rue de Rome
Avranches
Bayeux
Percy
Bain de Bretagne
Lons-le-Saunier
Ifs
Le Molay Littry
Le Chesnay
Le pont de montvert
Ploerdut
Ouistreham
Honfleur
Sannerville
Troarn
Colombelles
Saix
Potigny

intervention_type: Diagnostic Test


title: Pathways of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form : a Multicentre Prospective Study - National FPIES Observatory

acronym: SEIPA-FPIES

summary: Food protein induced enterocolitis syndrome (FPIES), is a non-IgE mediated food allergy (FA) which seems to expand, and occurring in infancy. This disease is usually unknown by clinicians. In 2017, an international workgroup of American Academy of Allergy, Asthma and Immunology published clinical criteria to specify the diagnosis. However, there is a lack of information in literature for describe the evolution and atypical phenotypes. In addition, no prospective French series has been published to date. The aim of the study is to collect clinical features and allergy testing of children who have acute form of FPIES at diagnosis and during evolution during three years

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval


acronym: LOGICAN

summary: Oxaliplatin ± nivolumab in combination with trifluridine/tipiracil or 5-fluorouracile (5-FU) in frail patients with advanced, recurrent or metastatic gastric, oesophageal or gastroesophageal junction cancer.

sponsor_collaborators: UNICANCER Servier

location_facility: Institut de cancérologie Strasbourg Europe

title: Randomised Phase II Study Evaluating Trifluridine/Tipiracil Plus Oxaliplatin ± Nivolumab Versus FOLFOX ± Nivolumab in Patients With Gastric, Oesophagus or Gastroesophageal Junction Adenocarcinoma Locally Advanced, Recurrent or Metastatic, Ineligible for Triplet Chemotherapy

source: euctr

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.