title: A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS)

summary:
This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival.

After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Poland
Spain
Italy
United Kingdom
France
Germany
Slovakia
Czechia

location_facility: Hopitaux Universitaires de Strasbourg - Hautepierre

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology

location_facility: IRCCS - Fondazione Piemonte Inst di Candiolo

location_facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

location_facility: Policlinico Universitario Campus Bio-Medico- Oncology Center


title: PHIL Evaluation in the Endovascular Treatment of Intracranial Cerebral ArterioVenous Malformation a European Multi-center, Observational, Prospective, Single Arm and Open Label Study

summary: The primary objective of this study is to assess the efficacy and safety of PHIL® liquid embolic agent in endovascular embolization of cerebral arteriovenous malformations.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Microvention-Terumo, Inc.

location_country:
Denmark
United Kingdom
Spain
France
Sweden

location_facility: Hospital Universitario General de Catalunya

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Hospital Regional Universitario Carlos Haya

lead_sponsor_type: industriel

status_simplified: Unknown


title: PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF, a European Multi-center, Observational, Prospective, Single Arm and Open Label Study.

summary: The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.

status: Completed

status_simplified: Completed


type: EudraCT Number

title: Phase I Dose-escalation of S 95005 (TAS-102) in Combination With Oxaliplatin in Metastatic Colorectal Cancer

summary: The main purpose of this study is to assess the safety and tolerability and to determine the recommended phase 2 dose of S 95005 given in combination with oxaliplatin in patients with metastatic colorectal cancer.

study_type: Interventional

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Argilés G, André T, Hollebecque A, Calvo A, Dahan L, Cervantes A, Leger C, Amellal N, Fougeray R, Tabernero J. Phase I dose-escalation of trifluridine/tipiracil in combination with oxaliplatin in patients with metastatic colorectal cancer. Eur J Cancer. 2019 May;112:12-19. doi: 10.1016/j.ejca.2019.01.101. Epub 2019 Mar 16.

ipd_sharing: Yes

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Spain
Italy
Austria
United Kingdom
Hungary
France
Germany

location_facility: ARNAS - Azienda Ospedaliera Garibaldi - Nesima Struttura Complessa di Oncologia Medica

location_facility: H. Uni. Madrid Sanchinarro - CIOCC Servicio de Oncología

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O.

location_facility: Universitätsklinikum Hamburg-Eppendorf II. Medizin. Klinik und Poliklinik (Onkologie, Hämatologie)

location_facility: Hôpital Saint-Antoine Service d'Oncologie Médicale

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly

location_facility: Klinikum Wolfsburg Medizinische Klinik II

location_facility: H. Clinico de Valencia INCLIVA - Departamento de Hematologia y Oncologia Medica 8ª planta

location_facility: H. Univ. Ramon y Cajal - Servicio de Oncología Medica

location_facility: ICO Badalona. H. Germans Trials y Pujol - Servicio de Oncología médica

location_facility: Universitätsklinikum Ulm Zentrum für Innere Medizin, Klinik für Innere Medizin I

location_facility: Christie Hospital NHS Foundation Trust GI & Endocrine

location_facility: Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III

location_facility: La Pitié Salpêtrière Centre Investigation clinique Paris Est

location_facility: Centre Eugène Marquis Service d'Oncologie Médicale

location_facility: Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie

location_facility: Semmelweis Egyetem I. sz. Belgyogyaszati Klinika - Klin. Farmakologiai Reszleg

location_facility: Policlinico G.B. Rossi A.O.U.I. di Verona U.O.C. di Oncologia

location_facility: Hospital Unviersitario Gregorio Marañon - Servicio de Oncología Médica

location_facility: H. Valle de Hebrón - Servicio de Oncología - (VHIR)

location_facility: Ist.Scientifico Romagnolo per lo Studio e la Cura dei Tumori Department of Clinical Oncology

location_facility: St. Josef-Hospital, Klinikum der Ruhr-Universität Bochum Abteilung für Hämatologie und Onkologie

location_facility: CHU de la Timone Hépato-Gastro-Entérologie - Oncology Digestive

intervention_type: Drug


title: Age-adjusted D-dimer Cut-off to Rule Out Pulmonary Embolism in the Emergency Department : A Real Life Impact Study

acronym: RELAX-PE

summary:
A multicentre multinational prospective management outcome study has recently proven the safety of a diagnostic strategy combining clinical probability assessment with an age-adjusted D-dimer cut-off, defined as a value of (age x 10) in patients > 50 years, for ruling out PE in outpatients, with a very low likelihood of subsequent symptomatic VTE. Moreover, this study showed that such a strategy increased the diagnostic yield of D-dimers, as it allowed ruling out PE without further investigation in a significantly higher proportion of patients than when using standard cut-off, particularly so in patients 75 years or older.

The objective of the present study is to confirm in a prospective cohort of "real life" patients the usefulness of the age-adjusted D-dimer cut-off to rule out PE in patients presenting to the emergency department with suspected PE.

ReferenceType: background

ReferenceCitation: Righini M, Van Es J, Den Exter PL, Roy PM, Verschuren F, Ghuysen A, Rutschmann OT, Sanchez O, Jaffrelot M, Trinh-Duc A, Le Gall C, Moustafa F, Principe A, Van Houten AA, Ten Wolde M, Douma RA, Hazelaar G, Erkens PM, Van Kralingen KW, Grootenboers MJ, Durian MF, Cheung YW, Meyer G, Bounameaux H, Huisman MV, Kamphuisen PW, Le Gal G. Age-adjusted D-dimer cutoff levels to rule out pulmonary embolism: the ADJUST-PE study. JAMA. 2014 Mar 19;311(11):1117-24. doi: 10.1001/jama.2014.2135. Erratum in: JAMA. 2014 Apr 23-30;311(16):1694.

ReferenceCitation: Robert-Ebadi H, Robin P, Hugli O, Verschuren F, Trinh-Duc A, Roy PM, Schmidt J, Fumeaux T, Meyer G, Hayoz D, Carron PN, Salaun PY, Sarasin F, Rutschmann O, Le Gal G, Righini M. Impact of the Age-Adjusted D-Dimer Cutoff to Exclude Pulmonary Embolism: A Multinational Prospective Real-Life Study (the RELAX-PE Study). Circulation. 2021 May 4;143(18):1828-1830. doi: 10.1161/CIRCULATIONAHA.120.052780. Epub 2021 May 3.

lead_sponsor: University Hospital, Geneva

location_country: France Switzerland Belgium

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Groupement Hospitalier de l'Ouest Lémanique

intervention_type: Other

lead_sponsor_type: academique


title: A Prospective, Multi-center, Open-label, Single-arm, Phase 2 Study to Assess the Efficacy and Safety of Clazosentan in Reversing Angiographically-confirmed Cerebral Vasospasm in Adult Subjects With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated by Surgical Clipping or Endovascular Coiling

acronym: REVERSE

summary: The purpose of this study is to evaluate the safety and potential therapeutic benefit of use of clazosentan in reversing cerebral vasospasm (a narrowing of blood vessels in the brain due to the presence of blood in the space around the brain) in patients who have suffered a condition known as aneurysmal subarachnoid hemorrhage caused by bleeding onto the surface of the brain from a ruptured brain aneurysm

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country: Finland Switzerland France

location_facility:
Site 1004
Site 1005
Site 1001
Site 3003
Site 1002
Site 3002
Site 3004
Site 2002
Site 1006
Site 3005
Site 3001


summary:
Objectives:

Primary Objective:

To identify and preselect patients with chronic HBV mono infection, who are undetectable for anti-Ad5 nAb, currently being treated with nucleo(t)sides, for participation in the TG1050.02 Phase1/1b First in Man (FIM) study.

Secondary Objectives:

To assess the prevalence of undetectable anti-Ad5 nAb in chronic HBV mono-infected patients.

Methodology:

Patients with chronic HBV mono-infection, who are currently being treated with nucleo(t)sides for their HBV infection, will be enrolled in this study to measure Ad5 nAb levels. A single peripheral blood collection (4 mL) will be obtained and Ad5 nAb titers will be measured by a central laboratory using a newly validated assay.

primary_purpose: Screening

lead_sponsor: Transgene

location_country: Germany Canada France


status: Unknown status

acronym: Transplant BRaVE

title: Phase I/II Feasibility Study Combining Brentuximab Vedotin With Second Line Salvage Chemotherapy (DHAP) in Hodgkin Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse Who Are Eligible for High Dose Treatment Followed by Autologous Peripheral Blood Stem Cell Transplantation (ASCT)

study_completion_date_type: Anticipated

lead_sponsor: Marjolein Spiering

type: Other Identifier

source: euctr

ReferenceCitation: Driessen J, Kersten MJ, Visser L, van den Berg A, Tonino SH, Zijlstra JM, Lugtenburg PJ, Morschhauser F, Hutchings M, Amorim S, Gastinne T, Nijland M, Zwezerijnen GJC, Boellaard R, de Vet HCW, Arens AIJ, Valkema R, Liu RDK, Drees EEE, de Jong D, Plattel WJ, Diepstra A; HOVON Lunenburg Lymphoma Phase I/II Consortium (LLPC). Prognostic value of TARC and quantitative PET parameters in relapsed or refractory Hodgkin lymphoma patients treated with brentuximab vedotin and DHAP. Leukemia. 2022 Oct 14. doi: 10.1038/s41375-022-01717-8. [Epub ahead of print]

ReferenceCitation: Kersten MJ, Driessen J, Zijlstra JM, Plattel WJ, Morschhauser F, Lugtenburg PJ, Brice P, Hutchings M, Gastinne T, Liu R, Burggraaff CN, Nijland M, Tonino SH, Arens AIJ, Valkema R, van Tinteren H, Lopez-Yurda M, Diepstra A, De Jong D, Hagenbeek A. Combining brentuximab vedotin with dexamethasone, high-dose cytarabine and cisplatin as salvage treatment in relapsed or refractory Hodgkin lymphoma: the phase II HOVON/LLPC Transplant BRaVE study. Haematologica. 2021 Apr 1;106(4):1129-1137. doi: 10.3324/haematol.2019.243238.

enrollment_type: Anticipated

location_country:
Denmark
France
Netherlands
United Kingdom

location_facility: Cambridge University Hospitals NHS Foundation Trust | Addenbrooke's Hospital

location_facility: King's College Hospital NHS Foundation Trust

summary: To combine Brentuximab Vedotin with Dexamethasone, AraC and Cisplatin (DHAP) chemotherapy in patients with Hodgkin lymphoma (HL) refractory to first line chemotherapy or in first relapse is expected to induce a significantly higher (metabolic) complete remission (CR) rate prior to consolidation with BEAM, as judged by FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose)-PET negativity. This will be compared with published data on DHAP salvage only. Increasing the metabolic CR rate prior to consolidation with high dose chemotherapy and autologous stem cell transplantation (ASCT) is expected to improve progression free survival (PFS) and overall survival (OS).


title: A Collaborative Retrospective Trial on the Efficacy and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients With Diabetic Macular Edema (DME). THE EUROPEAN DME REGISTRAR STUDY (ARTES)

acronym: ARTES

summary: To review the safety and efficacy of injections with Ozurdex (700 μg dexamethasone) in clinical practice management of patients with DME.

time_perspective: Retrospective

location_country:
Portugal
Spain
Italy
United Kingdom
Finland
Israel
France
Sweden

location_facility: Ophthalmology Clinical Trials Unit Frimley Park Hospital Foundation Trust

location_facility: Ophthalmology Department, Dos de Maig Hospital

location_facility: Department of Ophthalmology, Centre Hospitalier Henri Duffaut,

location_facility: Ophthalmology Department, Hospital de LaPaz

location_facility: Excellence Eye Research Centre University G. d'Annunzio of Chieti-Pescara

location_facility: Department of Ophthalmology Lariboisière Hospital

location_facility: Department of Ophthalmology University Vita Salute - Scientific Institute of San Raffael

location_facility: Centre for Clinical Trials, Department of Ophthalmology University of Padova

location_facility: Department of Ophthalmology Tel Aviv Sourasky Medical Center

location_facility: Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image

location_facility: Instituto de Retina e Diabetes Ocular de Lisboa (IRL)

location_facility: Department of Ophthalmology, Kuopio University Hospital

location_facility: NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, NHS Foundation Trust

location_facility: Hospital Vall d'Hebrón Department of Ophthalmology

location_facility: Ophthalmic Research Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs

location_facility: Ophthalmology Department, Kaplan Medical Center

location_facility: Department of Ophthalmology, Croix Rousse University Hospital

location_facility: Servicio de Oftalmologia, Hospital Universitario Y Politecnico de la Fe

location_facility: Department of Ophthalmology University of Udine

location_facility: Clinical Trial Unit, Department of Ophthalmology, CHU Nord, Aix Marseille University


title: Nanostim Study for a Leadless Cardiac Pacemaker System

summary: The objective of the study is to confirm clinical performance and safety of the Nanostim leadless cardiac pacemaker system within its intended use and according to its instructions for use.

ReferenceCitation: Reddy VY, Miller MA, Knops RE, Neuzil P, Defaye P, Jung W, Doshi R, Castellani M, Strickberger A, Mead RH, Doppalapudi H, Lakkireddy D, Bennett M, Sperzel J. Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience. Circ Arrhythm Electrophysiol. 2016 Dec;9(12). pii: e004626.

lead_sponsor: Abbott Medical Devices

location_country:
Spain
Italy
United Kingdom
Netherlands
France
Germany
Czechia

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: Universitätsmedizin Berlin - Campus Benjamin Franklin

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Manchester Heart Center, Manchester Royal Infirmary

intervention_type: Device


title: WEB Clinical Assessment of IntraSaccular Aneurysm Therapy

acronym: WEBCAST

summary: The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms

ReferenceCitation: Pierot L, Szikora I, Barreau X, Holtmannspoetter M, Spelle L, Klisch J, Herbreteau D, Costalat V, Fiehler J, Januel AC, Liebig T, Stockx L, Weber W, Berkefeld J, Moret J, Molyneux A, Byrne J. Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up. J Neurointerv Surg. 2022 Jul 8. pii: neurintsurg-2021-018414. doi: 10.1136/neurintsurg-2021-018414. [Epub ahead of print]

ReferenceCitation: Pierot L, Szikora I, Barreau X, Holtmannspoetter M, Spelle L, Herbreteau D, Fiehler J, Costalat V, Klisch J, Januel AC, Weber W, Liebig T, Stockx L, Berkefeld J, Moret J, Molyneux A, Byrne J. Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up. J Neurointerv Surg. 2021 Apr;13(4):363-368. doi: 10.1136/neurintsurg-2020-016151. Epub 2020 Jun 12.

ReferenceCitation: Pierot L, Spelle L, Molyneux A, Byrne J; WEBCAST and French Observatory Investigators. Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device: 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory). Neurosurgery. 2016 Jan;78(1):133-41. doi: 10.1227/NEU.0000000000001106.

location_country: Hungary Denmark France Germany

location_facility: Klinikum der Johann Wolfgang Goethe Universität

intervention_type: Procedure


title: Open-Label, Multi-Center, Phase 2 Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) in Subjects With Previously Treated Peripheral T-cell Lymphoma (PTCL)

summary: The primary objective of this study is to determine the overall response rate of KW-0761 for the treatment of patients with relapsed or refractory PTCL. KW-0761 targets CCR4. CCR4 is the receptor for macrophage derived chemokines MDC/CCL22 and TARC/CCL17. Chemokines are considered to play a role both in the recruitment of immune and inflammatory cells for anti-tumor response and in the selective homing of neoplastic B and T cells.

ReferenceCitation: Zinzani PL, Karlin L, Radford J, Caballero D, Fields P, Chamuleau ME, d'Amore F, Haioun C, Thieblemont C, González-Barca E, García CG, Johnson PW, van Imhoff GW, Ng T, Dwyer K, Morschhauser F. European phase II study of mogamulizumab, an anti-CCR4 monoclonal antibody, in relapsed/refractory peripheral T-cell lymphoma. Haematologica. 2016 Oct;101(10):e407-e410. Epub 2016 Jul 14.

lead_sponsor: Kyowa Hakko Kirin Pharma, Inc.

location_country:
Denmark
Spain
Italy
United Kingdom
France
Netherlands

location_facility: Universitair Medisch Centrum Groningen (UMCG)

location_facility: Cancer Research UK Centre/Southhampton General Hospital

location_facility: Institut Catalá D'Oncologia, Hospital Duran y Reynals

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

intervention_type: Biological


title: DOVIGIST: Phase II Trial to Evaluate the Efficacy and Safety of Dovitinib (TKI258) in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib

summary: The purpose of this study is to evaluate the efficacy and safety of Dovitinib in patients with gastrointestinal stromal tumors refractory and/or intolerant to Imatinib

lead_sponsor: Novartis Pharmaceuticals

location_country: Spain Italy Finland France Germany


acronym: REASON

title: (REASON) Double-blind, Randomized Phase II Study to Evaluate the Safety and Efficacy of Acetyl-l-carnitine in the Prevention of Sagopilone-induced Peripheral Neuropathy.

lead_sponsor: Bayer

design_allocation: Randomized

ReferenceCitation: Campone M, Berton-Rigaud D, Joly-Lobbedez F, Baurain JF, Rolland F, Stenzl A, Fabbro M, van Dijk M, Pinkert J, Schmelter T, de Bont N, Pautier P. A double-blind, randomized phase II study to evaluate the safety and efficacy of acetyl-L-carnitine in the prevention of sagopilone-induced peripheral neuropathy. Oncologist. 2013;18(11):1190-1. doi: 10.1634/theoncologist.2013-0061. Epub 2013 Oct 8.

location_country:
United Kingdom
Italy
Netherlands
France
Belgium
Germany

summary: This study investigates the safety and efficacy of Acetyl-L-Carnitine and compares it to the safety and efficacy of a placebo (inactive) tablet in the prevention of Sagopilone-induced peripheral neuropathy. Patients will receive intravenous infusion of sagopilone for 3 hours on day 1 of a 3-weeks cycle. Treatment with Sagopilone will be given as long as the patient is benefitting. In addition patients will receive ALC or placebo, starting 1 week before first sagopilone infusion and ending 30-33 days after the last infusion with sagopilone. Safety will be determined by laboratory and other evaluations. Efficacy of ALC will be determined by the incidence of all grades of peripheral neuropathy with the results of a patient questionnaire. Efficacy of the combination of ALC and Sagopilone will be determined by the tumor response.


title: Prospective, Open-Label, Non-Comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) With Voriconazole in Patients With Allogeneic Stem Cell Transplants (SCT).

acronym: VOSIFI

summary: To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants

design_allocation: Non-Randomized

primary_purpose: Prevention

lead_sponsor: Pfizer

location_country:
Portugal
Spain
United Kingdom
Switzerland
Sweden
France
Belgium
Germany


title: Randomized Phase II of TARCEVA™ (Erlotinib) Versus Temozolomide Or BCNU in Patients With Recurrent Glioblastoma Multiforme

summary:
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide and carmustine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether erlotinib is more effective than temozolomide or carmustine in treating recurrent glioblastoma multiforme.

PURPOSE: This randomized phase II trial is studying erlotinib to see how well it works compared to temozolomide or carmustine in treating patients with recurrent glioblastoma multiforme.

ReferenceType: result

ReferenceCitation: van den Bent MJ, Brandes AA, Rampling R, Kouwenhoven MC, Kros JM, Carpentier AF, Clement PM, Frenay M, Campone M, Baurain JF, Armand JP, Taphoorn MJ, Tosoni A, Kletzl H, Klughammer B, Lacombe D, Gorlia T. Randomized phase II trial of erlotinib versus temozolomide or carmustine in recurrent glioblastoma: EORTC brain tumor group study 26034. J Clin Oncol. 2009 Mar 10;27(8):1268-74. doi: 10.1200/JCO.2008.17.5984. Epub 2009 Feb 9.

location_country:
United Kingdom
Italy
France
Belgium
Netherlands

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc


title: Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of MEN-10755 in treating patients who have progressive prostate cancer that has not responded to hormone therapy.

ReferenceCitation: Fiedler W, Tchen N, Bloch J, Fargeot P, Sorio R, Vermorken JB, Collette L, Lacombe D, Twelves C; EORTC new drug development group. A study from the EORTC new drug development group: open label phase II study of sabarubicin (MEN-10755) in patients with progressive hormone refractory prostate cancer. Eur J Cancer. 2006 Jan;42(2):200-4. Epub 2005 Dec 7.

location_country: Spain Switzerland France Israel Belgium Germany

location_facility: Centre de Lutte Contre le Cancer, Georges-Francois Leclerc


title: Open Label Phase II Study on RFS 2000 (9-Nitro-camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Advanced Ovarian Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced ovarian cancer.

location_country:
Spain
Italy
United Kingdom
Switzerland
France
Israel
Belgium


title: European Multicentre Registry of Percutaneous Paravalvular Leak Closure - EuroPVL Study

acronym: EuroPVL

summary:
Paraprosthetic cardiac valve leaks are a progressive complication after after surgical or percutaneous heart valve replacement. These leaks can lead to heart failure and/or life-threatening hemolysis.

Percutaneous closure of para-prosthetic leaks has been developed as an alternative to surgery in high-risk patients. These procedures remain technically challenging with a significant risk of failure and complications, but this risk is improved since the development of dedicated prostheses and the increased experience of the operators. The data in the literature concerning percutaneous leak closure remain limited and disparate and mostly retrospective.The impact of the procedures on the quality of life of patients is not known. Beyond the technical aspects and the follow-up of major cardiovascular events, investigators also wonder what is the impact of these procedures on the quality of life of patients. Investigators hypothesize that even a partial reduction in paraprosthetic leakage may be associated with an improvement in quality of life through reduction of transfusion needs and/or reduction of dyspnea. A prospective study is warranted to assess the technical and clinical and clinical results of these procedures, together with the evaluation of the the possible benefit on the quality of life of the patients.

status: Recruiting

lead_sponsor: Centre Chirurgical Marie Lannelongue

location_country:
Poland
Spain
Italy
Greece
Latvia
Mexico
Lithuania
United Kingdom
France
Turkey
Belgium
Czechia

location_facility: National and kapodistrian university of athens

location_facility: hospital infantil de Mexico Frederico Gomez

location_facility: Pauls Stradins Clinical University Hospital

status_simplified: Ongoing


title: HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With Confirmed or Probable SARS-CoV-2 Infection. A Before and After Implementation of a Consensus Help-decision Making Rule Study

acronym: HOME-CoV

summary:
COVID-19 pandemic has developed worldwide in less than 4 months. The clinical presentations are variable widely, ranging from simple rhinitis to major lung damage that can lead to death.

In many countries involved in the ongoing health disaster due to SARS-CoV-2 infection, hospital are overloaded. In this context, the decision to hospitalize or to manage COVID-19 patients at home is crucial and defining reliable and consensual criteria is a major issue.

HOME-CoV study is a multicentre quasi-experimental interventional study, before and after implementation of a help-decision making rule (HOME-CoV rule), developed via the Delphi method.

Our main hypothesis is that a strategy based on the consensual HOME-CoV rule compared to current practice is at least as safe as regards the 7-day-rate of adverse events (safety criterion) and more effective as regards the rate of patients eventually managed as outpatients (efficacy criterion).

ReferenceCitation: Douillet D, Penaloza A, Mahieu R, Morin F, Chauvin A, Gennai S, Schotte T, Montassier E, Thiebaud PC, Ghuysen François A, Dall'acqua D, Benhammouda K, Bissokele P, Violeau M, Joly LM, Andrianjafy H, Soulie C, Savary D, Riou J, Roy PM; Hospitalization or Outpatient Management of Patients With SARS-CoV-2 Infection Study Group. Outpatient Management of Patients With COVID-19: Multicenter Prospective Validation of the Hospitalization or Outpatient Management of Patients With SARS-CoV-2 Infection Rule to Discharge Patients Safely. Chest. 2021 Oct;160(4):1222-1231. doi: 10.1016/j.chest.2021.05.008. Epub 2021 May 15.

ReferenceCitation: Douillet D, Mahieu R, Boiveau V, Vandamme YM, Armand A, Morin F, Savary D, Dubée V, Annweiler C, Roy PM; HOME-CoV expert group. Outpatient management or hospitalization of patients with proven or suspected SARS-CoV-2 infection: the HOME-CoV rule. Intern Emerg Med. 2020 Nov;15(8):1525-1531. doi: 10.1007/s11739-020-02483-0. Epub 2020 Sep 4.

lead_sponsor: University Hospital, Angers

location_country: France Monaco Belgium

location_facility: Centre Hospitalier Universitaire de Nantes


acronym: ALBAN

title: An Open Label, Randomized, Phase III Trial, Evaluating Efficacy of Atezolizumab in Addition to One Year BCG (Bacillus CaLmette-Guerin) Bladder Instillation in BCG-naive Patients With High-risk Non-muscle Invasive Bladder cANcer

lead_sponsor: UNICANCER

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

location_country: France Spain Belgium

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Centre Hospitalier Universitaire Marseille

location_facility: Hôpital privé Toulon - Sainte Marguerite

location_facility: Centre Hospitalier Universitaire Bordeaux

location_facility: Hospital Universitario de Jerez de la Frontera

location_facility: Centre Hospitalier Universitaire Lyon Sud

summary:
This is an open-label, randomized, multicentric study in patients with high-risk non-muscle invasive bladder cancer who had never received BCG for this disease.

The objective is to evaluate the efficacy of atezolizumab as measured by recurrence-free survival.


title: A Randomized Phase III Trial of Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab Versus Platinum Chemotherapy Plus Paclitaxel and Bevacizumab in Metastatic (Stage IVB), Persistent, or Recurrent Carcinoma of the Cervix

acronym: BEATcc

summary:
The study will integrate the efficacy of combining the anti programmed death-ligand 1 (anti-PD-L1) agent atezolizumab with the current standard of care in Stage IVB , persistent or recurrent carcinoma of the cervix, namely cisplatin or carboplatin/paclitaxel/bevacizumab. It will be explored the combination of bevacizumab plus atezolizumab, with no patient selection based on PD-L1 expression, allowing an all-comer assessment of atezolizumab activity.

The study is a randomized open label phase III trial to investigate the impact of atezolizumab in combination with bevacizumab and cisplatin or carboplatin /paclitaxel chemotherapy on overall survival and will employ the intent to treat principle, and random assignment to one of the 2 arms will be balanced according to disease histology (squamous cell carcinoma vs adenocarcinoma), prior platinum therapy as a radiation sensitizer (no prior cis-Radiotherapy (RT) versus prior cis-RT) and chemotherapy backbone (cisplatin vs carboplatin).

This trial will be run in an open label design due to the following considerations: the control arm is the standard of care for women diagnosed with metastatic, persistant or recurrent cervical cancer because of its impact on overall survival and the primary endpoint of the study is overall survival (OS), so blinding is not needed to ensure a robust assessment.

status: Active, not recruiting

ReferenceCitation: Grau JF, Farinas-Madrid L, Oaknin A. A randomized phase III trial of platinum chemotherapy plus paclitaxel with bevacizumab and atezolizumab versus platinum chemotherapy plus paclitaxel and bevacizumab in metastatic (stage IVB), persistent, or recurrent carcinoma of the cervix: the BEATcc study (ENGOT-Cx10/GEICO 68-C/JGOG1084/GOG-3030). Int J Gynecol Cancer. 2020 Jan;30(1):139-143. doi: 10.1136/ijgc-2019-000880. Epub 2019 Oct 23.

lead_sponsor: Grupo Español de Investigación en Cáncer de Ovario

location_country:
Spain
Italy
Sweden
United States
France
Norway
Japan
Germany

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: AOU Città della Salute e della Scienza di Torino, Presidio Sant'Anna

location_facility: Intitut Català d' Oncolgia L' Hospitalet

location_facility: Complejo Hospitalario Regional de Málaga

location_facility: Hospital Universitario Donostia- Donostia Unibertsitate Ospitalea

location_facility: AUSL Romagna - P.O. di Ravenna, Lugo, Faenza, Rimini e Cattolica

location_facility: Hosptial Clinico Universitario de Santiago de Compostela

location_facility: Istituto Nazionale Tumori Di Napoli Irccs Pascale

location_facility: Niigata University Medical & Dental Hospital

location_facility: Hospital Clinico Universitario Virgen Arrixaca

location_facility: Groupe Hospitalier Diaconesses-Croix Saint-Simon

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Azienda Ospedaliero-Universitaria Di Ferrara

location_facility: Saitama medical university international medical center

location_facility: Azienda Sanitaria Universitaria Integrata Di Udine


status: Enrolling by invitation

acronym: UMBRELLA

title: mUlticenter, Single-arM, Open-laBel, Long-teRm Safety Study With macitEntan in Patients With puLmonary Arterial Hypertension previousLy Treated With mAcitentan in Clinical Studies

lead_sponsor: Actelion

location_country:
Poland
Belarus
Russian Federation
Ukraine
France
Turkey
Belgium

location_facility: Cardiovascular Pathology Research Institute of Siberian Branch of RAMS

location_facility: Federal North-West Medical Research Centre

location_facility: CHU de Montpellier - Arnaud de Villeneuve

location_facility: Centre Hospitalier Universitaire - de Nice - Hopital Pasteur

location_facility: Federal State Budgetary Institution Of Ministry Of Health Of Russian Federation

location_facility: Federal State Budget Scientific Institution

location_facility: National Medical Research Center of Cardiology of MoH of Russian Federation

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'

location_facility: Minsk Regional Clinical Hospital Of The Red Banner Of Labor

location_facility: Hopital Bicêtre - Aphp Hôpitaux Universitaires Paris-Sud

location_facility: Wojewodzki Szpital Specjalistyczny, Oddzial Kardiologiczny

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

location_facility: GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel

summary: The aim of the trial is to study the long-term safety of macitentan and to provide continued treatment with macitentan to patients with pulmonary arterial hypertension (PAH) and Chronic thromboembolic pulmonary hypertension (CTEPH) who were previously treated with macitentan in clinical studies.


title: Combination of Targeted Therapy (Encorafenib and Binimetinib) Followed by Combination of Immunotherapy (Ipilimumab and Nivolumab) vs Immediate Combination of Immunotherapy in Patients With Unresectable or Metastatic Melanoma With BRAF V600 Mutation : an EORTC Randomized Phase II Study (EBIN)

acronym: EBIN

summary: This is a multicenter, 2-arm open-label, randomized comparative phase II study. The objective of this trial is to prospectively evaluate whether a sequential approach with an induction period of 12 weeks with encorafenib + binimetinib followed by combination immunotherapy with nivolumab + ipilimumab improves progression free survival compared to combination immunotherapy nivolumab + ipilimumab alone in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

ipd_sharing_description: All publications must comply with the terms specified in the EORTC Policy 009 "Release of Results and Publication Policy".

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Poland
Spain
Italy
United Kingdom
Netherlands
France
Belgium
Germany

location_facility: Univ. Mainz - Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center

location_facility: CHU de Dijon - Centre Georges-François-Leclerc

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon

location_facility: Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (APHM)

location_facility: Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: East & North Hertfordshire NHS Trust - East and North Hertfordshire NHS Trust - Mount Vernon Hospital

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)


title: An Open Label Phase II Study to Evaluate the Efficacy and Safety of Induction and Consolidation Therapy With Dasatinib in Combination With Chemotherapy in Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL).

summary:
The use of imatinib in combination or in association with chemotherapy is now considered as the gold standard for the treatment of Ph+ ALL. The complete remission (CR) rate is 90% versus 20% to 40% with chemotherapy alone. The combination of imatinib, vincristine and dexamethasone is a well tolerated regimen in aged patients and is also associated with a high CR rate of 80% to 90% in patient aged 55 years and over.
However, despite high CR rates, the progression free survival rate at 12 months of patients treated with the combination of imatinib and chemotherapy is 30% to 50%. Relapses remain frequent and only patients intensified with allogenic haematopoietic stem cell transplantation are in long term remission. This strategy is not fully applicable to most patients aged 55 years and over.
Relapses after or during imatinib therapy in patients with Ph+ ALL are associated with BCR-ABL tyrosine kinase domain mutation in 80% of cases, predominantly of the p-loop. The exact incidence of the T315I mutation is controversial and can be estimated to be near 50%. Conversely, the detection of the T315I or F317 mutation in a patient is a very strong predictor of relapse.
Dasatinib is a potent SCR and BCR-ABL tyrosine kinase inhibitor with preserved in vitro activity in most of the BCR-ABL mutated cell lines, except for the T315I and F317 mutations. This is also the case in vivo, with patients harbouring BCR-ABL TK domain mutations remaining sensitive to dasatinib. The CHR rate in Ph+ ALL resistant to imatinib is 33% and the median progression-free survival is 3.7 months. Progression free survival (PFS) rate at 12 months is 22%.

The goal of this trial is to evaluate the efficacy and the tolerance of the combination of dasatinib with chemotherapy in the front-line setting as induction and consolidation therapy in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be used in this trial with the addition of dasatinib as concomitant therapy during induction and alternating with chemotherapy during consolidation and maintenance. A CR rate of 90% and a progression free survival of 60% at 12 months are expected. The patients will be prospectively monitored for minimal residual disease and mutation.

lead_sponsor: Versailles Hospital

location_country: Germany France Italy Belgium

location_facility: Centre Hospitalier Départemental FELIX GUYON


title: Phase I/II Feasibility Study of Brentuximab Vedotin in Refractory / Relapsed Hodgkin Lymphoma Patients Who Are Treated by Chemotherapy (ICE) in Second Line and Eligible for Autologous Transplantation

acronym: BV-ICE

summary:
This study is designed as a phase Ib/II trial. The first part (phase Ib) is a dose escalation design to explore the safety and assess the recommended phase 2 dose of Brentuximab Vedotin in Hodgkin lymphoma patients treated with ICE regimen.

The second part, depending on the selected dose after the completion of phase Ib part of the study, will further explore safety in addition to efficacy of the recommended dose of Brentuximab Vedotin in a selected population of patients treated with ICE with Hodgkin lymphoma.

ReferenceCitation: Stamatoullas A, Ghesquières H, Feugier P, André M, Le Bras F, Gac AC, Borel C, Gastinne T, Quittet P, Morschhauser F, Ribrag V, Guidez S, Nicolas-Virelizier E, Berriolo-Riedinger A, Vander Borght T, Edeline V, Brice P. Final results of brentuximab vedotin combined with ifosfamide-carboplatin-etoposide in first refractory/relapsed Hodgkin lymphoma: a lymphoma study association phase I/II study. Leuk Lymphoma. 2022 Aug 17:1-9. doi: 10.1080/10428194.2022.2107204. [Epub ahead of print]

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: France Belgium

location_facility: CHU de Poitiers - Hôpital de La Milétrie

location_facility: Institut d'Hématologie de Basse Normandie - CHU Côte de Nacre


title: Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis- In-TARGET

acronym: In-TARGET

summary:
PHASE: IV

TYPE OF STUDY: With direct benefit

DESCRIPTIVE: multicenter, open-label, uncontrolled trial

INCLUSION CRITERIA: Adults with moderate to severe ulcerative colitis who failed corticosteroids and immunosupressive therapy, or are intolerant to immunosuppressors. All included patients will be naïve to anti-TNF therapy. Active disease at golimumab treatment initiation defined as a MAYO score ≥6 and with an endoscopic sub score ≥2.

OBJECTIVE: To determine the proportion of patients with Continuous Clinical Response (CCR) and endoscopic remission after one year of golumimab at week 54.

STUDY DESIGN:

Induction Phase :

Week 0: golimumab 200mg- Week 2: golimumab 100 mg- Week 6: golimumab 50 mg

Maintenance Phase I : Week 10-Week 54 Week 10-Week 54 • Patients with primary clinical response*: Standard regimen with golimumab 50 mg Q4W (or 100 mg Q4W if > 80 kg)

Patients without primary clinical response at week 10 or with flare between week 10-week 54*: Optimization to 100 mg Q4W (or combination therapy with azathioprine if > 80 kg or switch from azathioprine to methotrexate if already on azathioprine at golimumab initiation or patient with known intolerance to thiopurines)

Early escape at Week 18: Primary non-responders who are still not responding at week 18 to dose optimization at Weeks 10 and 14 will be considered treatment failures and will be followed up (call or visit) at week 54 for safety.

Clinical response is defined as a decrease from baseline in the Mayo score ≥30% and ≥3 points, accompanied by either a rectal bleeding sub score of 0 or 1 or a decrease from baseline in the rectal bleeding sub score ≥1

Intermittent Phase II : Week 54-Week 108

• Patients with CCR and MH at week 54 and on golimumab 50 mg every 4 weeks: Stop golimumab and continuation of thiopurines or methotrexate if on combination therapy

• Patients with CCR and MH at week 54 and on golimumab 100 mg every 4 weeks: De-escalation to 50 mg every 4 weeks and continuation of thiopurines or methotrexate if on combination therapy

• Restart/Escalate golimumab on flare (defined in section 4 of the protocol) to the phase I dose; 50 mg q4wk or 100mg q4wk (similar to the phase I regimen)

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility: CHU de Colmar- Hopital Trousseau Medecine A


title: Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients

acronym: S-ICD Brugada

summary:
Brugada syndrome is an inherited arrhythmia syndrome with an increased risk of syncope and sudden death resulting from episodes of polymorphic ventricular tachychardia and fibrillation. Currently, there is no medical therapy for the Brugada syndrome and the only treatment available is the implantation of an ICD. There is no discussion on the interest of the ICD implantation in secondary prevention and in patients who experienced syncope but the best therapeutic is more difficult to draw in asymptomatic patients. Recently we demonstrated that in asymptomatic patients with a spontaneous type 1 aspect of Brugada syndrome, (i) there was a significant risk of ventricular arrhythmia, (ii) the problem of inappropriate shocks can be solve with a good ICD programming and (iii) the problem of lead failure remains the main problem in this young population very active and represent the main limitation to larger indication of ICD implantation in this population with a very long life expectancy as these patients had a normal life expectancy except the risk of ventricular arrhythmia.

In this context the S-ICD System (Boston Scientific Inc.) which is an implantable defibrillator technology that treats ventricular tachyarrhythmias using a subcutaneous pulse generator and electrode system rather than a transvenous lead system, represents a very attractive opportunity as it gives the possibility to protect the patients of the risk of ventricular arrhythmia with no risk of lead failure. However, as this is a new technology and as Brugada syndrome patients are a very specific population (very active patients, specific and changing over time ECG aspect that is at risk of T wave over sensing and high risk of SVT), it seems important to evaluate the effectiveness and the safety of S-ICD in this specific context.

lead_sponsor: Nantes University Hospital

location_country: Denmark Spain Italy France Germany

location_facility: Paris University Hospital - La pitié-Salpétrière


title: Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury

acronym: EPURE

summary:
Limited prospective data is available to compare morbidity and mortality between renal replacement modalities in pediatric acute renal failure.

In the absence of clear standard of care, the choice of the extra renal replacement therapy modality is subject to clinical judgement, practical aspects, and costs.

This study will supply important data about usual modalities of pediatric acute extra renal replacement therapy and their impact on patient outcome and renal recovery. An obvious next step will be to conduct a randomized controlled trial comparing the different strategies.

lead_sponsor: Rennes University Hospital

location_country: Canada Réunion France

location_facility: Réanimation et Surveillance - Robert Debre Hospital

location_facility: Pediatry - Cote De Nacre University Hospital

location_facility: Anesthesy-Pediatric reanimation - Nord University Hospital

location_facility: Pediatric reanimation - Hôpital mère-enfant

location_facility: Pediatric nephrology - Hôpital Couple-enfants

location_facility: Pediatry - Hopital de la Mère et de l'Enfant

location_facility: Nephrology - Pediatric emergency - Clocheville University Hospital

location_facility: Pediatric intensive care - Centre mère enfants

location_facility: Pediatric Nephrology and dianetology - Arnaud de Villeneuve Hospital

location_facility: Pediatric reanimation - Brabois Hospital


title: Phase 2/3 Study Evaluating Efficacy and Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA)Versus Reference L-asparaginase Treatment in Combination With Standard Polychemotherapy in Patient With First Recurrence of Philadelphia Negative Acute Lymphoblastic Leukemia

acronym: GRASPIVOTALL

summary:
Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by toxicities including hypersensitivity. Clinical allergy is associated with inactivation of asparaginase by antibodies (A-Abs), which can also neutralize asparaginase without any clinical signs of hypersensitivity (silent inactivation). GRASPA improves pharmacokinetics, tolerability and maintain circulating asparaginase activity due to the protective barrier of the erythrocyte membrane.

This study is run to confirm the benefit/risk profile of GRASPA at 150 IU/kg in combination with the COOPRALL regimen in adults and children patients with relapsed ALL, with or without known hypersensitivity to L-asparaginase.

lead_sponsor: ERYtech Pharma

location_facility: Institut Hematologie Oncologie Pediatrique


title: A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance

summary:
The aims of this study are:

to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and
to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B).

ReferenceCitation: Azzouzi AR, Vincendeau S, Barret E, Cicco A, Kleinclauss F, van der Poel HG, Stief CG, Rassweiler J, Salomon G, Solsona E, Alcaraz A, Tammela TT, Rosario DJ, Gomez-Veiga F, Ahlgren G, Benzaghou F, Gaillac B, Amzal B, Debruyne FM, Fromont G, Gratzke C, Emberton M; PCM301 Study Group. Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase 3, randomised controlled trial. Lancet Oncol. 2017 Feb;18(2):181-191. doi: 10.1016/S1470-2045(16)30661-1. Epub 2016 Dec 20.

ReferenceCitation: Azzouzi AR, Barret E, Bennet J, Moore C, Taneja S, Muir G, Villers A, Coleman J, Allen C, Scherz A, Emberton M. TOOKAD® Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer. World J Urol. 2015 Jul;33(7):945-53. doi: 10.1007/s00345-015-1505-8. Epub 2015 Feb 25.

ReferenceCitation: Lebdai S, Villers A, Barret E, Nedelcu C, Bigot P, Azzouzi AR. Feasibility, safety, and efficacy of salvage radical prostatectomy after Tookad® Soluble focal treatment for localized prostate cancer. World J Urol. 2015 Jul;33(7):965-71. doi: 10.1007/s00345-015-1493-8. Epub 2015 Jan 23.

ipd_sharing_description: The data are available in case report form for each patient

lead_sponsor: Steba Biotech S.A.

location_country:
Spain
Italy
United Kingdom
Netherlands
Finland
Switzerland
Sweden
France
Belgium
Germany

location_facility: Unità di Chirurgia Urologica Mininvasiva

location_facility: ATURO-Gemeinschaftspraxis für Urologie und Andrologie

location_facility: Vinzenz Krankenhaus - Department of Urology

location_facility: Hospital 12 de Octubre - Departmento de Urologia

location_facility: Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia

location_facility: Clinique d'Urologie et de Transplantation Rénale CHU Grenoble

location_facility: Department of Urology-Tampere University Hospital-

location_facility: Unità Operativa Urologia Lucca - c/o Azienda USL 2 - Ospedale Campo di Marte

location_facility: Dept. of Urology-University Hospitals Leuven

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität

location_facility: Martini-Klinik am UKE Hamburg-Eppendorf Prostate Cancer Center

location_facility: Centre Hospitalier Universitaire de Rangueil

location_facility: Unità Operativa Urologica di Savona, Ospedale San Paolo di Savona

location_facility: Department of Urology-Hospital Clinic, University of Barcelona

location_facility: Complejo Hospitalario Regional Virgen Del Rocio-Department Urology

location_facility: Hospital Universitari de Bellbitge-Servico de Urologia

location_facility: Centre Hospitalier Universitaire Lyon Sud

location_facility: Service d'Urologie - Centre Hospitalier Universitaire d'Angers


acronym: RiBECCA

title: A Randomized Study to Assess the Effect on Response Rate of MabThera (Rituximab) Added to a Standard Chemotherapy, Bendamustine or Chlorambucil, in Patients With Chronic Lymphocytic Leukemia

lead_sponsor: Hoffmann-La Roche

location_country:
Portugal
Spain
United Kingdom
Finland
Tunisia
France
Turkey
Sweden

summary: This randomized, open-label, parallel group study will assess the effect on response rate and the safety of MabThera added to either bendamustine or chlorambucil in patients with chronic lymphocytic leukemia. Patients will be randomized to receive six 4-week cycles of either A) MabThera (375mg/m2 iv day 1 of cycle 1, 500mg/m2 iv cycles 2-6) plus bendamustine (90mg/m2 as first-line or 70mg/m2 as second-line therapy, iv on days 1 and 2, cycles 1-6), or B)MabThera plus chlorambucil (10mg/m2 po daily, days 1-7, cycles 1-6). Patients in group B can receive up to 6 further cycles of chlorambucil as monotherapy. Anticipated time on study treatment is 6-12 months, and target sample size is 600-700 individuals.


title: A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer

summary: Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.

lead_sponsor: Ferring Pharmaceuticals

location_country: Portugal Spain Italy France Turkey Belgium Sweden

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: Azienda Ospedaliero Universitaria Ospedali riuniti

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo

location_facility: Centro Hospitalar Lisboa Norte, Hospital Santa Maria

location_facility: Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau

location_facility: Hospital Universitario Principe de Asturias

location_facility: Istanbul University Faculty of Medicine - ÇAPA

location_facility: Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna

location_facility: Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma

location_facility: Hospital Clinico Universitario S. Carlos

location_facility: S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: CRLC Val d' Aurelle - Oncology Radiotherapy

location_facility: Ankara University Faculty of Medicine - Sıhhıye

location_facility: Hôpital Saint Louis - Radiotherapy Departement

location_facility: Hospital Universitario Central de Asturias

location_facility: Cerrahpasa Faculty of Medicine - Kocamustafapasa

location_facility: Clinica Urologica - Azienda Ospedaliera di Perugia

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

location_facility: Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette

location_facility: Marmara University Faculty of Medicine - Altunizade


acronym: OCTAVIA

title: A Single-arm Phase II Clinical Study Investigating the Addition of Bevacizumab to Carboplatin and Weekly Paclitaxel as First-line Treatment in Patients With Epithelial Ovarian Cancer

ReferenceCitation: Gonzalez-Martin A, Gladieff L, Tholander B, Stroyakovsky D, Gore M, Scambia G, Kovalenko N, Oaknin A, Ronco JP, Freudensprung U, Pignata S; OCTAVIA Investigators. Efficacy and safety results from OCTAVIA, a single-arm phase II study evaluating front-line bevacizumab, carboplatin and weekly paclitaxel for ovarian cancer. Eur J Cancer. 2013 Dec;49(18):3831-8. doi: 10.1016/j.ejca.2013.08.002. Epub 2013 Sep 2.

location_country:
Brazil
Spain
Italy
Russian Federation
United Kingdom
Sweden
France
Norway
Netherlands

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

location_facility: The Norvegian Radium Hospital Montebello; Dept of Oncology

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: Academisch Medisch Centrum; Inwendige Geneeskunde

location_facility: Hopital Antoine Beclere; Service de Medecine Interne

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Uni Hospital Linkoeping; Dept. of Oncology

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B

location_facility: Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Medisch Spectrum Twente Enschede; Internal Medicine

location_facility: Centre Hospitalier Henri Duffaut; Hematologie

location_facility: St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde

location_facility: Sint Elizabeth Ziekenhuis; Inwendige Geneeskunde

location_facility: A.O. Universitaria Policlinico Di Modena; Oncologia

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

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Hospital das Clinicas - FMUSP, Oncologia

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Örebro University Hospital; Department of Gynecologic Oncology

location_facility: Institut de Cancerologie de La Loire; Radiotherapie

summary: This single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8 3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy, bevacizumab could be continued to be given as a monotherapy.


title: Observational Cohort Study to Evaluate Safety and Efficacy of Pradaxa (Dabigatran Etexilate) in Patients With Moderate Renal Impairment (Creatinine Clearance 30-50 ml/Min) Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery

summary: An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment

lead_sponsor: Boehringer Ingelheim

location_country:
Spain
Italy
Austria
United Kingdom
Sweden
France
Germany

location_facility: 1160.84.03909 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04938 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3311 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3305 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3403 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3402 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3314 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3323 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3412 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4604 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04948 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04913 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3306 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4301 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3303 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3332 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04401 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3334 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04929 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3313 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3322 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.03908 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3312 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04405 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4601 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04408 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3404 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3316 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04407 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3326 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3410 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04903 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04902 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04403 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4603 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04914 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3310 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04946 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04947 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3405 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4922 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3320 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3409 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04927 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3401 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4310 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3335 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.03904 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3302 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3319 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.03902 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3324 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3307 Boehringer Ingelheim Investigational Site


title: Multicenter, Randomized Study Comparing the Efficacy and Safety of Two Doses of Thalidomide (100 mg/Day Versus 400 mg/Day) in the Treatment of Subjects With Refractory or Relapsed Multiple Myeloma.

summary: The objective of this study is to show that thalidomide at a dose of 100 mg/d (with remedial treatment with dexamethasone if a progression occurs) is equivalent in terms of efficacy with thalidomide at 400 mg/d (with remedial treatment with dexamethasone if a progression occurs) in the treatment of refractory or relapsed multiple myeloma after at least two courses of treatment. The use of thalidomide at 100 mg/d should reduce the side effects and improve the safety of the treatment.

ReferenceCitation: Yakoub-Agha I, Mary JY, Hulin C, Doyen C, Marit G, Benboubker L, Voillat L, Moreau P, Berthou C, Stoppa AM, Maloisel F, Rodon P, Dib M, Pegourie B, Casassus P, Slama B, Damaj G, Zerbib R, Harousseau JL, Mohty M, Facon T; Intergroupe Francophone du Myélome (IFM). Low-dose vs. high-dose thalidomide for advanced multiple myeloma: a prospective trial from the Intergroupe Francophone du Myélome. Eur J Haematol. 2012 Mar;88(3):249-59. doi: 10.1111/j.1600-0609.2011.01729.x. Epub 2012 Jan 4.

lead_sponsor: Celgene

location_facility: Centre Hospitalier Laennec - Service de Médecine A

location_facility: Centre Hospitalier - Service Hematologie

location_facility: CENTRE HOSPITALIER DEPARTEMENTAL - Sce Médecine A

location_facility: Centre Hospitalier Du Dr Duschene - Hematologie

location_facility: CHU Hôpital Brabois - Médecine interne-Hématologie

location_facility: Centre Hospitalier H. Duffaut - Hematologie

location_facility: CHR Hôp N.D. de Bon Secours - Service de Médecine A

location_facility: HOPITAL JEAN MINJOZ - Médecine interne/Hématologie

location_facility: Centre Hospitalier - Service de Médecine 7

location_facility: Centre Hospitalier Général - Service d'Hématologie

location_facility: C.H.U. de Saint Etienne - Hôpital Bellevue - Sce Rhumatologie

location_facility: Centre Hospitalier Chubert - Médecine Interne

location_facility: Centre Hospitalier D'Annecy - Service d'oncohématologie

location_facility: Centre Hospitalier La Rochelle - Unité d'Oncologie Médicale

location_facility: Hopital Avicenne - Medecine Interne/Hematologie

location_facility: Centre Hospitalier de Blois - Unité d'Onco-Hématologie

location_facility: CHRU Hôtel Dieu, Service des Maladies du Sang

location_facility: HOPITAL HAUTEPIERRE - Service Rhumatologie

location_facility: Centre Hospitalier - Service de Rhumatologie

location_facility: Centre Henri Becquerel - Service Hématologie

location_facility: INSTITUT PAOLI CALMETTE - Unité transplantation

location_facility: Centre Hospitalier General - Medecine Interne


title: Prospective Study of Predictive Factors of Sustained Remission of Crohn's Disease After Stopping Infliximab

acronym: STORI

summary:
1 Project summary 1.1 Rational. Accent 1 study has demonstrated the superiority of Infliximab over placebo in a systematic treatment strategy of Crohn 's disease every 8 weeks during one year. However the optimal strategy beyond one year of treatment is not established. Particularly, the need for carrying on systematic treatment with infliximab in all the patients has not been demonstrated.

1.2 Primary objective. Determine factors associated with a low risk of clinical relapse after stopping infliximab in CD patients in remission (CDAI<150) and regularly treated with infliximab for at least one year.

1.3 Main objective and main judgement criteria. Determine predictive factors for relapse within one year after stopping infliximab. Main judgement criteria is the clinical relapse after stopping infliximab. Clinical relapse is defined either by a CDAI>250 or by a CDAI between 150 and 250 if this CDAI is confirmed over two consecutive weeks with an increase of at least 70 points over baseline for the two consecutive measures.

1.4 Secondary objectives and judgement criteria. Determine the time to-relapse Determine predictive factors for short-term relapse (<2 months)after stopping infliximab.

Determine response to infliximab retreatment in these patients. Determine tolerance to infliximab retreatment in these patients. Determine predictive factors for an absence of response to retreatment. Determine predictive factors for infliximab retreatment intolerance. Determine sustained response in the retreated patients.

1.5 Type of study Open-label prospective study of stopping regular treatment. Inclusion period: minimum one year, possibly prolonged to reach 100 patients. Patients will be followed up every two months for at least 18 months after stopping infliximab.

1.6 Justification of the number of patients Number of patients to include is at least 100. This recruitment should be reached within one year. This number should allow to disclose predictive factors associated with a relative risk of at least 2 if this factor is equilibrated (50% at risk patients) or 3 is this factor is disequilibrated (90% at risk patients).

ReferenceCitation: Vermeire S, Louis E, Carbonez A, Van Assche G, Noman M, Belaiche J, De Vos M, Van Gossum A, Pescatore P, Fiasse R, Pelckmans P, Reynaert H, D'Haens G, Rutgeerts P; Belgian Group of Infliximab Expanded Access Program in Crohn's Disease. Demographic and clinical parameters influencing the short-term outcome of anti-tumor necrosis factor (infliximab) treatment in Crohn's disease. Am J Gastroenterol. 2002 Sep;97(9):2357-63.

ReferenceCitation: Parsi MA, Achkar JP, Richardson S, Katz J, Hammel JP, Lashner BA, Brzezinski A. Predictors of response to infliximab in patients with Crohn's disease. Gastroenterology. 2002 Sep;123(3):707-13.

ReferenceCitation: Farrell RJ, Alsahli M, Jeen YT, Falchuk KR, Peppercorn MA, Michetti P. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease: a randomized controlled trial. Gastroenterology. 2003 Apr;124(4):917-24.

ReferenceCitation: Baert F, Noman M, Vermeire S, Van Assche G, D' Haens G, Carbonez A, Rutgeerts P. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med. 2003 Feb 13;348(7):601-8.

ReferenceCitation: Tampo Y, Yonaha M. Antioxidant mechanism of Mn(II) in phospholipid peroxidation. Free Radic Biol Med. 1992;13(2):115-20.

ReferenceCitation: Parsi MA, Lashner BA. Safety of infliximab: primum non nocere. The safety profile of infliximab in patients with Crohn's disease: the Mayo Clinic experience in 500 patients. Inflamm Bowel Dis. 2004 Jul;10(4):486-7.

ReferenceCitation: Keane J, Gershon S, Wise RP, Mirabile-Levens E, Kasznica J, Schwieterman WD, Siegel JN, Braun MM. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med. 2001 Oct 11;345(15):1098-104.

ReferenceCitation: Louis E, Mary JY, Vernier-Massouille G, Grimaud JC, Bouhnik Y, Laharie D, Dupas JL, Pillant H, Picon L, Veyrac M, Flamant M, Savoye G, Jian R, Devos M, Porcher R, Paintaud G, Piver E, Colombel JF, Lemann M; Groupe D'etudes Thérapeutiques Des Affections Inflammatoires Digestives. Maintenance of remission among patients with Crohn's disease on antimetabolite therapy after infliximab therapy is stopped. Gastroenterology. 2012 Jan;142(1):63-70.e5; quiz e31. doi: 10.1053/j.gastro.2011.09.034. Epub 2011 Sep 22.

location_facility:
Hopital Lariboisiere
CHU LYON
Hopital Saint Louis
Hopital Saint Andre
Chu Amiens
Chu Strasbourg
Hopital Haut Leveque
CHU CAEN
Chu Nantes
CHRU Lille
Chu Besancon
Chu Marseille - Hopital Nord
CHU LIEGE - Sart Tilman
Chu Montpellier
Hopital Georges Pompidou
Chu Toulouse
Gent University Hospital
Hopital Henri Mondor
Ch Le Raincy Montfermeil
Hopital Louis Mourier
Hopital Beaujon
Chu Rouen
Chu Tours


title: A Controlled, Randomized, Double-blind, Multicenter Study, Comparing Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis

acronym: METEOR

summary:
PHASE: II
TYPE OF STUDY : With direct benefit
DESCRIPTIVE: Multicenter, randomized, double-blind study
INCLUSION CRITERIA: Steroid-dependent ulcerative colitis
OBJECTIVES: To show superiority of methotrexate vs placebo in inducing steroid-free remission in steroid-dependent ulcerative colitis
STUDY TREATMENTS: Methotrexate 1 intramuscular injection (25 mg) per week Placebo 1 intramuscular injection per week
NUMBERS OF PATIENTS: 55 patients in each group, i.e. a total of 110 patients
INCLUSION PERIOD: 24 months
STUDY DURATION: 36 months
EVALUATION CRITERIA: Remission without steroids, immunosuppressives and without colectomy at 16 weeks of treatment.

ReferenceCitation: Carbonnel F, Colombel JF, Filippi J, Katsanos KH, Peyrin-Biroulet L, Allez M, Nachury M, Novacek G, Danese S, Abitbol V, Bossa F, Moreau J, Bommelaer G, Bourreille A, Fumery M, Roblin X, Reinisch W, Bouhnik Y, Brixi H, Seksik P, Malamut G, Färkkilä M, Coulibaly B, Dewit O, Louis E, Deplanque D, Michetti P, Sarter H, Laharie D; European Crohn's and Colitis Organisation; Groupe d'Étude Thérapeutique des Affections Inflammatoires Digestives. Methotrexate Is Not Superior to Placebo for Inducing Steroid-Free Remission, but Induces Steroid-Free Clinical Remission in a Larger Proportion of Patients With Ulcerative Colitis. Gastroenterology. 2016 Feb;150(2):380-8.e4. doi: 10.1053/j.gastro.2015.10.050. Epub 2015 Nov 26.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_country: Italy Austria France Israel Belgium Netherlands

location_facility: CHU Clermont-Ferrand - Hôpital Hotel Dieu

location_facility: Centre Hospitalier Universitaire de Besançon


title: Intermediate and High Risk Localized, Completely Resected, Gastrointestinal Stromal Tumors (GIST) Expressing KIT Receptor: A Controlled Randomized Trial on Adjuvant Imatinib Mesylate (Glivec) Versus No Further Therapy After Complete Surgery

summary:
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after surgery may kill any remaining tumor cells. It is not yet known whether imatinib mesylate is more effective than observation only in treating gastrointestinal stromal tumor.

PURPOSE: This randomized phase III trial is studying imatinib mesylate to see how well it works compared to observation only in treating patients who have undergone surgery for localized gastrointestinal stromal tumor.

ReferenceCitation: Gronchi A, Bonvalot S, Poveda Velasco A, Kotasek D, Rutkowski P, Hohenberger P, Fumagalli E, Judson IR, Italiano A, Gelderblom HJ, van Coevorden F, Penel N, Kopp HG, Duffaud F, Goldstein D, Broto JM, Wardelmann E, Marréaud S, Smithers M, Le Cesne A, Zaffaroni F, Litière S, Blay JY, Casali PG. Quality of Surgery and Outcome in Localized Gastrointestinal Stromal Tumors Treated Within an International Intergroup Randomized Clinical Trial of Adjuvant Imatinib. JAMA Surg. 2020 Jun 1;155(6):e200397. doi: 10.1001/jamasurg.2020.0397. Epub 2020 Jun 17.

ReferenceCitation: Casali PG, Le Cesne A, Poveda Velasco A, Kotasek D, Rutkowski P, Hohenberger P, Fumagalli E, Judson IR, Italiano A, Gelderblom H, Adenis A, Hartmann JT, Duffaud F, Goldstein D, Broto JM, Gronchi A, Dei Tos AP, Marréaud S, van der Graaf WT, Zalcberg JR, Litière S, Blay JY. Time to Definitive Failure to the First Tyrosine Kinase Inhibitor in Localized GI Stromal Tumors Treated With Imatinib As an Adjuvant: A European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Intergroup Randomized Trial in Collaboration With the Australasian Gastro-Intestinal Trials Group, UNICANCER, French Sarcoma Group, Italian Sarcoma Group, and Spanish Group for Research on Sarcomas. J Clin Oncol. 2015 Dec 20;33(36):4276-83. doi: 10.1200/JCO.2015.62.4304. Epub 2015 Nov 16.

location_country:
Denmark
Spain
United Kingdom
Australia
France
Germany

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Grupo Espanol de Investigacion del Cancer de Mama

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Southwest German Cancer Center at Eberhard-Karls-University


title: A 24 Week, Randomised, Double Blind, Parallel Study to Compare the Change in HbA1c With AVANDAMET® (8.0mg / 2.0g) Plus Insulin to Placebo Plus Insulin, in Subjects With Type 2 Diabetes Starting Insulin Therapy

summary: This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in combination with insulin in improving the control of blood sugar when compared with taking insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both AVANDIA and metformin are medicines which are individually licensed for the treatment of type II diabetes mellitus. Because they act in different ways, it is thought that combining them may give an increased benefit of treating diabetes and reducing blood sugar.

ReferenceCitation: Home PD, Bailey CJ, Donaldson J, Chen H, Stewart MW. A double-blind randomized study comparing the effects of continuing or not continuing rosiglitazone + metformin therapy when starting insulin therapy in people with Type 2 diabetes. Diabet Med. 2007 Jun;24(6):618-25. Epub 2007 Apr 2. Erratum in: Diabet Med. 2010 May;27(5):611.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country: Spain Italy Austria France Germany


title: Efficacy and Safety Study Exploring Nangibotide Treatment in COVID-19 pAtients With ventiLatory Support (ESSENTIAL) A Randomized, Double-blind, Placebo-controlled Study With Adaptive Features

acronym: ESSENTIAL

summary:
This is a randomized, double-blind, placebo-controlled, in which one dose of nangibotide will be tested versus placebo.

All patients with a diagnosis of COVID-19, and a requirement for respiratory support will be considered for study participation. The applicable local requirements for informed consent will be followed. Where permissible, an emergency consent procedure will be followed for patients unable to provide consent by themselves. All potential study patients will receive standard of care treatment throughout the study. Patients will receive a continuous intravenous (i.v.) infusion of nangibotide at 1.0 mg/kg/h or a matching placebo. Treatment with study drug must be initiated as early as possible but no later than 48 hours after the initiation of ventilatory support (Patients will be treated for 5 days or until discharge from critical care, whichever is sooner). Follow-up visits will be performed on days 8 and 14. The end of study visit is at day 28. A further follow up visit will be undertaken on day 60.

lead_sponsor: Inotrem

location_facility: CHU Dijon - Bourgogne - Hôpital François Mitterrand

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: CHD Site la Roche sur Yon, les Oudairies


title: A Prospective, Multi-center Phase II Study of Subcutaneous Alemtuzumab Combined With Oral Dexamethasone, Followed by Alemtuzumab Maintenance or Allogeneic Stem-cell Transplantation, in Chronic Lymphocytic Leukemia Which is Associated With 17p Deletion or is Refractory to Fludarabine

lead_sponsor: University of Ulm

ReferenceCitation: Edelmann J, Holzmann K, Tausch E, Saunderson EA, Jebaraj BMC, Steinbrecher D, Dolnik A, Blätte TJ, Landau DA, Saub J, Estenfelder S, Ibach S, Cymbalista F, Leblond V, Delmer A, Bahlo J, Robrecht S, Fischer K, Goede V, Bullinger L, Wu CJ, Mertens D, Ficz G, Gribben JG, Hallek M, Döhner H, Stilgenbauer S. Genomic alterations in high-risk chronic lymphocytic leukemia frequently affect cell cycle key regulators and NOTCH1-regulated transcription. Haematologica. 2020 May;105(5):1379-1390. doi: 10.3324/haematol.2019.217307. Epub 2019 Aug 29.

ReferenceCitation: Steinbrecher D, Jebaraj BMC, Schneider C, Edelmann J, Cymbalista F, Leblond V, Delmer A, Ibach S, Tausch E, Scheffold A, Bloehdorn J, Hallek M, Dreger P, Döhner H, Stilgenbauer S. Telomere length in poor-risk chronic lymphocytic leukemia: associations with disease characteristics and outcome. Leuk Lymphoma. 2018 Jul;59(7):1614-1623. doi: 10.1080/10428194.2017.1390236. Epub 2017 Oct 24.

location_country: Austria Germany France

location_facility: Centre Hospitalier Marechal Joffre Hôpital Saint-Jean Perpignan

summary:
Aims and objectives

Assessment of the efficacy of the study treatment in the study population in terms of response rate, progression-free survival, failure-free survival and overall survival.
Acquisition of further data to expand the data base on the toxicity of the study treatment.
Assessment of the efficacy of the study treatment in biological risk groups.
Assessment of response in terms of minimal residual disease. Number of patients and estimated duration Total no. of patients: 122 (~29 with 17p deletion for first-line therapy, ~29 with 17p deletion for second- or higher-line treatment, ~65 fludarabine-refractory irrespective of 17p status).

Duration for each patient: Max. 12 weeks of treatment in three 4-week cycles, then up to two years maintenance treatment.


title: A Single Arm Open-label, Phase II Study of Bevacizumab in Combination With Trastuzumab and Capecitabine as First-line Treatment of Patients With HER2-positive Locally Recurrent or Metastatic Breast Cancer

ReferenceCitation: Martín M, Makhson A, Gligorov J, Lichinitser M, Lluch A, Semiglazov V, Scotto N, Mitchell L, Tjulandin S. Phase II study of bevacizumab in combination with trastuzumab and capecitabine as first-line treatment for HER-2-positive locally recurrent or metastatic breast cancer. Oncologist. 2012;17(4):469-75. doi: 10.1634/theoncologist.2011-0344. Epub 2012 Mar 30.

location_country:
Denmark
Spain
Russian Federation
France
Sweden
Slovakia

summary: This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.


title: A Randomized, Double Blind, Placebo-controlled Phase II, Multi-Centre Study to Assess the Efficacy and Safety of Vandetanib (ZD6474) in Patients With Locally Advanced or Metastatic Papillary or Follicular Thyroid Carcinoma Failing or Unsuitable for Radioiodine Therapy

lead_sponsor: Genzyme, a Sanofi Company

ReferenceCitation: Leboulleux S, Bastholt L, Krause T, de la Fouchardiere C, Tennvall J, Awada A, Gómez JM, Bonichon F, Leenhardt L, Soufflet C, Licour M, Schlumberger MJ. Vandetanib in locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 2 trial. Lancet Oncol. 2012 Sep;13(9):897-905. doi: 10.1016/S1470-2045(12)70335-2. Epub 2012 Aug 14.

location_country: Denmark Spain Switzerland France Belgium Norway Sweden

summary:
This is a parallel group, randomized, double blind, placebo controlled, multicentre study designed to assess whether vandetanib (ZD6474) confers an improvement in PFS as compared to placebo in subject with locally advanced or metastatic papillary or follicular thyroid carcinoma failing or unsuitable for radioiodine therapy. The trial should be of a sufficient size so that if vandetanib (ZD6474) is truly active there is a high probability that it will demonstrate an effect sufficiently promising to warrant a follow-up assessment.

Subjects will be seen weekly for the first 2 weeks, then again at Week 4, Week 8, and Week 12 after randomization, and every 12 weeks thereafter. Upon disease progression, all subjects (both active and placebo) will be unblinded and given the option to discontinue blinded study treatment and enter follow up and survival, or begin open label vandetanib (ZD6474) 300 mg treatment. All subjects will be followed to collect survival data until ≥50% of subjects have died. Subjects who are taking vandetanib (ZD6474) at the time of study closure and wish to remain on therapy will be allowed to continue for as long as the Investigator feels that they are obtaining clinical benefit, or until they are given another anti-cancer therapy. The safety data from all subjects will be assessed on an ongoing basis, including discontinuation and follow up.
Radiologic evaluation using RECIST criteria will be performed every 12 weeks (± 2 weeks). All medical images will be centralized assessed at the site and centrally reviewed. Subjects will be evaluated until progression, and will then be followed up for survival, regardless of whether they continue randomized treatment, unless they withdraw consent. Post progression open-label vandetanib (ZD6474) will be offered at the investigators discretion.
All subjects must submit a suitable archived tumor sample prior to randomization. In the event that a suitable archived sample is not available within 2 weeks prior to randomization, a fresh tumor sample must be obtained in its place prior to randomization. If a subject undergoes the fresh tumor biopsy procedure, this specimen will satisfy the first optional tumor biopsy submission should they consent to the exploratory part of the study.


title: Infusional 5-Fluorouracil With or Without Cisplatin and With or Without Chronomodulation Against Locally-Advanced or Metastatic Pancreatic Cancer. A Multicenter Randomized Phase III Trial.

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether fluorouracil plus cisplatin are more effective than fluorouracil alone in treating patients with metastatic cancer of the pancreas.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil with or without cisplatin in treating patients who have advanced or metastatic cancer of the pancreas.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Portugal Italy France Israel Belgium

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Centre de Lutte Contre le Cancer, Georges-Francois Leclerc


title: A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults.

acronym: EliSA

summary: The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio™ system, used according to its instructions for use, in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 3 years post-surgery.

lead_sponsor: Nyxoah S.A.

location_country: Netherlands Switzerland France Belgium Germany

location_facility: Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie

location_facility: Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde Universitätsklinikum Regensburg

location_facility: Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn

location_facility: HNO-Klinik des Universitätsklinikums Jena

location_facility: CEREVES Paris Jean Jaurès - Centre du sommeil

location_facility: Klinik für Hals-, Nasen-, Ohrenheilkunde der Charité am Standort CCM Charité - Universitätsmedizin Berlin

location_facility: Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches Zentrum

location_facility: Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie

location_facility: Hôpital Bichat, Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Asklepios Klinikum Harburg, Abt. für HNO-Heilkunde, Kopf- und Halschirurgie


title: Prospective Observational Study on the Use of Inhaled NO (iNO) Administered Through an Integrated deliVEry and Monitoring Device EZ-KINOX

acronym: POSITIVE

summary:
This is a prospective, observational, multicenter study conducted during 1 year in adult and paediatric intensive care units equipped with the EZ-KINOX™ system.

A maximum of 250 patients (newborns to adults, suffering from Pulmonary Arterial Hypertension (PAH) associated with cardiac surgery or Persistent Pulmonary Hypertension in the Newborn (PPHN) receiving iNO through the integrated delivery and monitoring EZ-KINOX™ system was planned to be included.

The study is strictly non-interventional with the aim of describing current practices and therefore did not affect the patient usual management.

ReferenceCitation: Pepke-Zaba J, Higenbottam TW, Dinh-Xuan AT, Stone D, Wallwork J. Inhaled nitric oxide as a cause of selective pulmonary vasodilatation in pulmonary hypertension. Lancet. 1991 Nov 9;338(8776):1173-4.

ReferenceCitation: Gaudard P, Barbanti C, Rozec B, Mauriat P, M'rini M, Cambonie G, Liet JM, Girard C, Leger PL, Assaf Z, Damas P, Loron G, Lecourt L, Amour J, Pouard P. New Modalities for the Administration of Inhaled Nitric Oxide in Intensive Care Units After Cardiac Surgery or for Neonatal Indications: A Prospective Observational Study. Anesth Analg. 2018 Apr;126(4):1234-1240. doi: 10.1213/ANE.0000000000002813.

lead_sponsor: Air Liquide Santé International

location_facility: CHU Montpellier - Hôpital Arnaud de Villeneuve


title: European Multicenter Validation of an ADNEXMR SCORING System for Characterizing Adnexal Masses: "EURAD-MR Classification"

acronym: EURAD

summary:
An adnexal mass is the most common indication for gynaecological surgery . Pre operative characterization is crucial and a scoring system would be useful to standardize the imaging report and thus, improve patient management. Recently, our center developed the first MR scoring system named ADNEXMR SCORING system in a retrospective study which is accurate and reproducible (1). Our objectives are to perform an external prospective validation of this scoring system, to evaluate its potential impact on therapeutic strategy and to test its reproducibility.

This is a prospective large multicenter study. All patients with a sonographically indeterminate adnexal mass referred for MR imaging will be consecutively included in each center. Then, patients will undergo a routine pelvic MR imaging. Prospectively, one senior and one junior radiologists independently analyze the different MR criteria to characterize adnexal masses. The MR report will be issued as standard and the patient will be managed accordingly. Then, the reader will classify the mass using ADNEXMR SCORING system. The classification will be compared to the reference standard as defined below. The reproducibility of the classification will be tested between the junior and the senior radiologist. After anonymisation, images will be analyzed by another senior radiologist of another center blinded from any clinical or ultrasonographical data and correlated with the reference standard.

Reference standard: Reference standard will be surgical procedure with histology or standard clinical follow-up depending on most appropriate routine practice.

Sample size: The sample size was computed to ensure a power of at least 90% (with a two-sided type I error rate of 5%) to conclude that SCORE 2 and 3 and SCORE 4 and 5 would have a different PPV. It would thus be necessary to have at least 569 patients classified as SCORE 2, 259 as SCORE 3, 52 as SCORE 4 and 51 as SCORE 5 (18). Given the prevalences, and assuming 6% of patients would be classified, as SCORE 1 and 10% would be lost to follow-up, 1340 patients will be included in this study to insure a probability of at least 95% to obtain the aforementioned number of patients in each score category. The inclusion period will last 18 months (extension for a period of 12 months) and monitoring will continue for 2 years.

Thomassin Naggara I., et al. Development and preliminary validation of an MRI Scoring system for Adnexal Masses. Radiology 2013, May;267(2):432-43.

ReferenceCitation: Wengert GJ, Dabi Y, Kermarrec E, Jalaguier-Coudray A, Poncelet E, Porcher R, Thomassin-Naggara I, Rockall AG; EURAD Study Group. O-RADS MRI Classification of Indeterminate Adnexal Lesions: Time-Intensity Curve Analysis Is Better Than Visual Assessment. Radiology. 2022 Jun;303(3):566-575. doi: 10.1148/radiol.210342. Epub 2022 Mar 1. Erratum in: Radiology. 2022 May;303(2):E28.

lead_sponsor: Société d'Imagerie de la Femme

location_country:
Croatia
Portugal
Serbia
United Kingdom
Italy
Austria
Switzerland
France

location_facility: Instituto Portuges de Oncologia de Lisboa Francisco Gentil


acronym: CONCERT

title: A Phase II, Randomized, Open-label, Multicenter, Study Evaluating the Efficacy of Sorafenib Alone and Sorafenib in Combination With Low Dose Interferon Alpha-2a as Second-line Treatment of Sunitinib Failure in Patients With Metastatic Renal Cell Carcinoma

lead_sponsor: Bayer

location_country:
Poland
Spain
Italy
Austria
Ireland
United Kingdom
France

summary: This study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. This study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose interferon (3 million international unit (MIU) five times a week) can treat kidney cancer more effectively than the current approved dose alone and if it is safe. In addition, for patients that respond to treatment with sorafenib alone or in combination with interferon before progressing, patients may receive sorafenib alone at an increased dose of 300mg twice-daily, provided that toxicities are acceptable and at the discretion of the investigator.


title: An Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of Triptorelin 6-month Formulation Administered Subcutaneously in Participants With Locally Advanced and/or Metastatic Prostate Cancer Previously Treated and Castrated With a GnRH Analogue

acronym: TriptoSwitch

summary: The aim of the study is to determine if triptorelin formulated for use every 6 months (given twice during the study) is effective and safe for when given by injection under the skin for the treatment of adult males with cancer in the prostate.

ipd_sharing_description: Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.

lead_sponsor: Ipsen

location_country: Spain Netherlands Lithuania France Belgium Germany Czechia

location_facility: Saint Jean Languedoc and La Croix du Sud Hospital

location_facility: Hospital Universitario Virgen del Rocio- Urología Pediátrica

location_facility: Hospital Universitario Central de Asturias (HUCA)

location_facility: Hospital de La Santa Creu i Sant Pau - Oncología Médica

location_facility: Hopital Privé Métropole Lille - Polyclinique Du Bois

location_facility: POLUSA - Policlínico Lucense - Oncología

location_facility: Hopital Foch - Urologie et Transplantation Ré

location_facility: Polyclinique de Blois - Service oncologie

location_facility: Vilniaus Universiteto Ligonines Santtariskiu Klinikos

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: CHU Brest-Hopital Morvan Institut de Cancerologie et d'Hemat

location_facility: Centre Hospitalier Universitaire D'Angers - Urologie

location_facility: Hospital Universitario 12 de Octubre- Urology

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas


title: Open Label, Multicentre Study, Evaluating the Safety, Tolerability, Efficacy, Compliance and Acceptability of Alkalising Treatments at Long-term in Patients With Cystinuria

summary: This is an open label, multicentre study, evaluating the safety, tolerability, efficacy, compliance and acceptability of alkalising treatments at long-term in patients with cystinuria.

lead_sponsor: Advicenne Pharma

location_country: France Belgium

location_facility: Hôpital Ténon - Explorations fonctionnelles Mutlidisciplinaires et INSERM UMR S 1155

location_facility: Centre Hospitalier Universitaire de Lyon


title: Treatment of Cerebral Arteriovenous Malformations With SQUID Liquid Embolic Agent - The CHOICE Study A Non-interventional, Prospective, Single-arm, International, Multicenter Study

acronym: CHOICE

summary: The objective of this study is to further establish that SQUID, an alternative liquid embolic agent with specific properties, is a safe and effective alternative in bAVM endovascular treatment strategy available to date. Therefore, the performance of SQUID will be documented and its safety of use will be confirmed in current practice.

lead_sponsor: Embo-Flüssigkeiten A.G.

location_country: Denmark Italy France Belgium Germany

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Klinikum der Ruhr-Universität Bochum, Knappschaftskrankenhaus