title: Phase IB, Open-Label, Multicenter, Dose-Escalation Study Followed by an Extension Phase to Evaluate the Safety, Pharmacokinetics and Activity of RO5479599, a Glycoengineered Antibody Against HER3, Administered in Combination With Pertuzumab and Paclitaxel in Patients With Metastatic Breast Cancer Expressing HER3 & HER2 Protein

summary: This multicenter, open-label dose-escalation study with an extension phase will evaluate the safety and pharmacokinetics of lumretuzumab in combination with pertuzumab and paclitaxel in participants with metastatic breast cancer expressing HER3 and HER2 protein. Cohorts of participants will receive escalating doses of lumretuzumab intravenously (IV) every three weeks (Q3W) in combination with pertuzumab 840 milligrams (mg) IV initial dose followed by 420 mg IV Q3W and paclitaxel 80 milligrams per square meter (mg/m^2) IV weekly. After completion of dose-limiting toxicity period (21 days), the study will be conducted in two extension phase cohorts: Cohort 1 and Cohort 2. Enrollment in Extension Phase Cohort 2 will occur only upon completion of Extension Phase Cohort 1. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

ReferenceCitation: Schneeweiss A, Park-Simon TW, Albanell J, Lassen U, Cortés J, Dieras V, May M, Schindler C, Marmé F, Cejalvo JM, Martinez-Garcia M, Gonzalez I, Lopez-Martin J, Welt A, Levy C, Joly F, Michielin F, Jacob W, Adessi C, Moisan A, Meneses-Lorente G, Racek T, James I, Ceppi M, Hasmann M, Weisser M, Cervantes A. Phase Ib study evaluating safety and clinical activity of the anti-HER3 antibody lumretuzumab combined with the anti-HER2 antibody pertuzumab and paclitaxel in HER3-positive, HER2-low metastatic breast cancer. Invest New Drugs. 2018 Oct;36(5):848-859. doi: 10.1007/s10637-018-0562-4. Epub 2018 Jan 19.

lead_sponsor: Hoffmann-La Roche

location_country: Denmark France Germany Spain

location_facility: Universitaetsklinikum Essen; Westdeutsches Tumorzentrum; Innere Klinik (Tumorforschung)

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

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

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

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg


title: A Controlled, Prospective, Non-Inferiority, Parallel-Group, Randomised, Interventional, Open, Blinded Outcome Assessment (PROBE-Design), Multi-centre Trial, Comparing Efficacy and Safety of Isolation of the PVs With a Cryoballoon Catheter vs a Radiofrequency Ablation With a ThermoCool Catheter in Patients With PAF

summary: Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Fürnkranz A, Brugada J, Albenque JP, Tondo C, Bestehorn K, Wegscheider K, Ouyang F, Kuck KH. Rationale and Design of FIRE AND ICE: A multicenter randomized trial comparing efficacy and safety of pulmonary vein isolation using a cryoballoon versus radiofrequency ablation with 3D-reconstruction. J Cardiovasc Electrophysiol. 2014 Dec;25(12):1314-20. doi: 10.1111/jce.12529. Epub 2014 Nov 12.

ReferenceType: result

ReferenceCitation: Kuck KH, Brugada J, Fürnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.

ReferenceType: derived

ReferenceCitation: Kuck KH, Brugada J, Fürnkranz A, Chun KRJ, Metzner A, Ouyang F, Schlüter M, Elvan A, Braegelmann KM, Kueffer FJ, Arentz T, Albenque JP, Kühne M, Sticherling C, Tondo C; FIRE AND ICE Investigators. Impact of Female Sex on Clinical Outcomes in the FIRE AND ICE Trial of Catheter Ablation for Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2018 May;11(5):e006204. doi: 10.1161/CIRCEP.118.006204.

ReferenceCitation: Chun KRJ, Brugada J, Elvan A, Gellér L, Busch M, Barrera A, Schilling RJ, Reynolds MR, Hokanson RB, Holbrook R, Brown B, Schlüter M, Kuck KH; FIRE AND ICE Investigators. The Impact of Cryoballoon Versus Radiofrequency Ablation for Paroxysmal Atrial Fibrillation on Healthcare Utilization and Costs: An Economic Analysis From the FIRE AND ICE Trial. J Am Heart Assoc. 2017 Jul 27;6(8). pii: e006043. doi: 10.1161/JAHA.117.006043. Erratum in: J Am Heart Assoc. 2017 Sep 15;6(9):.

ReferenceCitation: Kuck KH, Fürnkranz A, Chun KR, Metzner A, Ouyang F, Schlüter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kühne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016 Oct 7;37(38):2858-2865. Epub 2016 Jul 5.

ReferenceCitation: Luik A, Radzewitz A, Kieser M, Walter M, Bramlage P, Hörmann P, Schmidt K, Horn N, Brinkmeier-Theofanopoulou M, Kunzmann K, Riexinger T, Schymik G, Merkel M, Schmitt C. Cryoballoon Versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: The Prospective, Randomized, Controlled, Noninferiority FreezeAF Study. Circulation. 2015 Oct 6;132(14):1311-9. doi: 10.1161/CIRCULATIONAHA.115.016871. Epub 2015 Aug 17.

lead_sponsor: Medtronic Atrial Fibrillation Solutions

location_country: Spain Italy Netherlands Switzerland Hungary France Germany Czechia

location_facility: La Clinique Pasteur, 45 Avenue de Lombez

location_facility: Cardiac Arrhythmia Research Centre Department of Cardiovascular Medicine Centro Cardiologico Monzino University of Milan

location_facility: CHU Lyon, Départment de Rythmologie, Hospital Cardiologique Pradel

location_facility: Hospital Henri Mondor CHU, Service de Cardiologie

location_facility: Universitätsspital Basel, Elektrophysiologie/ Kardiologie

location_facility: Hospital Universitario Virgen de la Victoria, Department of Cardiology, Campus Teatinos sn

location_facility: Cardioangiologisches Centrum Bethanien - CCB

location_facility: Semmelweis University of Medicine, Kardiovaskuläres Zentrum

location_facility: Hospital Clinico Universtitario, Cardiology Department Arrhythmia Unit

location_facility: Arrhythmia Unit Hospital Clinico San Carlos

location_facility: Hospital Clinic, University of Barcelona

location_facility: Isala Klinieken loc. Weezenlanden Diagram Clinical Resarch

location_facility: Klinik für Kardiologie II mit interventioneller Elektrophysiologie

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Completed


intervention_type: Biological

title: An Open-label, Multicenter, Dose-Escalation Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B

lead_sponsor: CSL Behring

type: Other Identifier

type: EudraCT Number

source: euctr

design_allocation: Non-Randomized

ReferenceCitation: Santagostino E, Negrier C, Klamroth R, Tiede A, Pabinger-Fasching I, Voigt C, Jacobs I, Morfini M. Safety and pharmacokinetics of a novel recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in hemophilia B patients. Blood. 2012 Sep 20;120(12):2405-11. Epub 2012 Aug 2.

location_country: Spain Italy Austria France Israel Germany

location_facility:
Study site
Study Site

summary: The primary objective of the study is to assess the safety of IV administration of rIX-FP. Safety will be evaluated by adverse events and laboratory changes over time. The secondary objective of the study is to evaluate the pharmacokinetics parameters, following a single intravenous dose of rIX-FP.


title: PERCEVAL Pivotal Trial

summary: The clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients. This study will be conducted at Investigational Centres in the European Community. A minimum number of 8 European Centres will be involved in the clinical investigation. A minimum of 15 patients will be enrolled at each Investigational Centre. The clinical follow-up requires evaluations at discharge (or 30 days if the patient is still hospitalized), 3-6 and 12 months following the procedure.The primary objective of this clinical investigation is to assess the performance of the Perceval S valve at 3-6 months after implantation in high surgical risk patients, who require a surgical intervention to replace the aortic valve.

lead_sponsor: Corcym S.r.l

location_country: Germany France Switzerland Belgium

location_facility:
Hôpital Cardiologique du Haut-Lévêque
Inselspital Bern
Medizinische Hochschule Hannover
Ruhr Universität Bochum
UZ Leuven
Hopital Guillaume et René Laennec
Westdeutsches Herzzentrum
CHRU de Lille
Institut Mutualiste Montsouris

intervention_type: Device


title: Transfemoral Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (EUROPE)

summary: A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), its transfemoral delivery system, and crimper accessories. The trial includes a premarket confirmatory cohort to evaluate the system performance as well as a Post Market Clinical Follow-up phase involving expanded enrollment and long-term follow-up of all patients to evaluate valve performance out to 5 years.

study_start_date_type: Actual

ipd_sharing: No

lead_sponsor: Edwards Lifesciences

location_country:
Germany
France
United Kingdom
Belgium

location_facility: Hamburg University Cardiovascular Center

location_facility: Ornze Lieve Vrouwziekenhuis (OLVZ) Aalst


title: Multi-Center, Open Label Study to Assess Early Response to Abatacept With Background Methotrexate Using Power Doppler Ultrasonography in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

summary: The purpose of the study is to assess early signs of response to abatacept+methotrexate in metacarpophalangeal joints in both hands using power Doppler ultrasonography in patients with active rheumatoid arthritis.

primary_purpose: Prevention

ReferenceCitation: D'Agostino MA, Boers M, Wakefield RJ, Berner Hammer H, Vittecoq O, Filippou G, Balint P, Möller I, Iagnocco A, Naredo E, Østergaard M, Gaillez C, Le Bars M. Exploring a new ultrasound score as a clinical predictive tool in patients with rheumatoid arthritis starting abatacept: results from the APPRAISE study. RMD Open. 2016 May 5;2(1):e000237. doi: 10.1136/rmdopen-2015-000237. eCollection 2016.

ReferenceCitation: Golinski ML, Vandhuick T, Derambure C, Fréret M, Lecuyer M, Guillou C, Hiron M, Boyer O, Le Loët X, Vittecoq O, Lequerré T. Dysregulation of RasGRP1 in rheumatoid arthritis and modulation of RasGRP3 as a biomarker of TNFα inhibitors. Arthritis Res Ther. 2015 Dec 26;17:382. doi: 10.1186/s13075-015-0894-9.

ReferenceCitation: D'Agostino MA, Wakefield RJ, Berner-Hammer H, Vittecoq O, Filippou G, Balint P, Möller I, Iagnocco A, Naredo E, Østergaard M, Boers M, Gaillez C, Van Holder K, Le Bars M; OMERACT-EULAR-Ultrasound Task Force. Value of ultrasonography as a marker of early response to abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results from the APPRAISE study. Ann Rheum Dis. 2016 Oct;75(10):1763-9. doi: 10.1136/annrheumdis-2015-207709. Epub 2015 Nov 20.

lead_sponsor: Bristol-Myers Squibb

location_country:
Denmark
Spain
Italy
United Kingdom
Hungary
France
Norway
Germany

intervention_type: Drug


title: Vascular-Targeted Photodynamic Therapy Using WST 11 in Patients With Localized Prostate Cancer

summary:
The aim of this clinical study is to determine the optimal treatment conditions to achieve prostate cancer tumor ablation and to assess the effects of WST11 mediated VTP treatment in patients with localized prostate cancer.

The secondary objectives is to evaluate safety and quality of life ; to assess the pharmacokinetic parameters and to model the relationship between concentration and effects; and to assess the effects, the safety and quality of life of a second WST11 VTP treatment in patients with persistent or recurrent localized prostate cancer after a first VTP;

ReferenceCitation: Moore CM, Azzouzi AR, Barret E, Villers A, Muir GH, Barber NJ, Bott S, Trachtenberg J, Arumainayagam N, Gaillac B, Allen C, Schertz A, Emberton M. Determination of optimal drug dose and light dose index to achieve minimally invasive focal ablation of localised prostate cancer using WST11-vascular-targeted photodynamic (VTP) therapy. BJU Int. 2015 Dec;116(6):888-96. doi: 10.1111/bju.12816. Epub 2015 Apr 21.

ReferenceCitation: Azzouzi AR, Lebdai S, Benzaghou F, Stief C. Vascular-targeted photodynamic therapy with TOOKAD® Soluble in localized prostate cancer: standardization of the procedure. World J Urol. 2015 Jul;33(7):937-44. doi: 10.1007/s00345-015-1535-2. Epub 2015 Mar 19.

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.

ReferenceCitation: Colin P, Estevez JP, Betrouni N, Ouzzane A, Puech P, Leroy X, Biserte J, Villers A, Mordon S. [Photodynamic therapy and prostate cancer]. Prog Urol. 2011 Feb;21(2):85-92. doi: 10.1016/j.purol.2010.07.018. Epub 2010 Sep 17. Review. French.

ipd_sharing: Yes

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

lead_sponsor: Steba Biotech S.A.

location_country:
Canada
United Kingdom
France

location_facility: University Health Network-Princess Margaret Hospital


title: Comparison of Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus

summary: This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.

ReferenceCitation: Ligthelm RJ, Mouritzen U, Lynggaard H, Landin-Olsson M, Fox C, le Devehat C, Romero E, Liebl A. Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections: a randomised open-label parallel group four months comparison in patients with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Oct;114(9):511-9.

lead_sponsor: Novo Nordisk A/S

location_country:
Croatia
Poland
Hong Kong
Spain
United Kingdom
Russian Federation
Netherlands
Sweden
France
Singapore
Romania
Malaysia
Germany


acronym: SAKK 56/07 (DaFLiG)

title: Dasatinib First-Line Treatment in Gastrointestinal Stromal Tumors. A Multi Center Phase II Trial

lead_sponsor: Swiss Group for Clinical Cancer Research

location_country: Germany Finland Switzerland France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hopital Cantonal Universitaire de Geneve

summary:
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works as first-line therapy in treating patients with gastrointestinal stromal tumors.


title: An Evaluation of a Doppler-Guided Uterine Artery Occlusion Device as Treatment for the Reduction of Fibroid-Associated Bleeding

summary: The primary objective of this study is to evaluate the safety and effectiveness of Doppler guided Uterine Artery Occlusion (D-UAO) as treatment for the reduction of fibroid-associated symptoms.

status: Terminated

lead_sponsor: Ethicon, Inc.

location_country:
Denmark
United Kingdom
Netherlands
Switzerland
France
Norway
Germany

location_facility: CHRU de Lille, Hopital Jeanne de Flandre

location_facility: Service de Gynecologie Obsterique, Hopital Antoine Beclere

location_facility: Queen Elizabeth the Queen Mother Hospital

location_facility: Hull and East Yorkshire Women & Children Hospital

status_simplified: Unknown


title: Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in HCV Positive in Liver Transplantation

acronym: CHASE

summary: This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.

lead_sponsor: Astellas Pharma Inc

location_country:
Poland
Spain
Italy
United Kingdom
Czech Republic
Sweden
France
Germany


title: A Multicenter, Open, Phase II Study to Estimate the Activity and Safety of Caspofungin (CASP) in the First-Line Treatment of Probable and Proven Invasive Aspergillosis (IA) in Patients With Hematological Malignancies (HM) or Recipients of Autologous Haematopoietic Stem Cell Transplantation and Those With Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)

summary:
RATIONALE: Antifungals, such as caspofungin acetate, may be effective in treating fungal infections caused by chemotherapy or stem cell transplant.

PURPOSE: This phase II trial is studying how well caspofungin acetate works as first-line treatment for aspergillosis in patients with hematologic cancer or in patients who have undergone a stem cell transplant.

primary_purpose: Supportive Care

ReferenceCitation: Viscoli C, Herbrecht R, Akan H, Baila L, Sonet A, Gallamini A, Giagounidis A, Marchetti O, Martino R, Meert L, Paesmans M, Ameye L, Shivaprakash M, Ullmann AJ, Maertens J; Infectious Disease Group of the EORTC. An EORTC Phase II study of caspofungin as first-line therapy of invasive aspergillosis in haematological patients. J Antimicrob Chemother. 2009 Dec;64(6):1274-81. doi: 10.1093/jac/dkp355. Epub 2009 Oct 19.

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

location_country: Italy Switzerland France Turkey Belgium Germany Slovakia

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

location_facility: Hacettepe University - Faculty of Medicine

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Medizinische Poliklinik, Universitaet Wuerzburg

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman


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/Metastatic Urothelial Tract Tumors

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 metastatic cancer of the urinary tract.

location_country: Spain Italy Switzerland France Israel Belgium Netherlands

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


title: A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of liposomal doxorubicin is more effective for metastatic breast cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of liposomal doxorubicin in treating women who have metastatic breast cancer.

ReferenceCitation: Biganzoli L, Coleman R, Minisini A, Hamilton A, Aapro M, Therasse P, Mottino G, Bogaerts J, Piccart M. A joined analysis of two European Organization for the Research and Treatment of Cancer (EORTC) studies to evaluate the role of pegylated liposomal doxorubicin (Caelyx) in the treatment of elderly patients with metastatic breast cancer. Crit Rev Oncol Hematol. 2007 Jan;61(1):84-9. Epub 2006 Nov 20.

ReferenceCitation: Coleman RE, Biganzoli L, Canney P, Dirix L, Mauriac L, Chollet P, Batter V, Ngalula-Kabanga E, Dittrich C, Piccart M. A randomised phase II study of two different schedules of pegylated liposomal doxorubicin in metastatic breast cancer (EORTC-10993). Eur J Cancer. 2006 May;42(7):882-7. Epub 2006 Mar 7.

location_country:
Spain
Italy
Austria
Greece
United Kingdom
Switzerland
France
Israel
Netherlands

location_facility: Mario Negri Institute for Pharmacological Research

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Ludwig Boltzmann - Institute for Applied Cancer Research


title: Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Pancreatic Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hydration with a saline solution may protect kidney cells from the side effects of chemotherapy.

PURPOSE: Randomized phase II trial to compare the effectiveness of glufosfamide with or without hydration in treating patients who have pancreatic cancer that is metastatic or cannot be removed by surgery.

ReferenceCitation: Briasoulis E, Pavlidis N, Terret C, Bauer J, Fiedler W, Schöffski P, Raoul JL, Hess D, Selvais R, Lacombe D, Bachmann P, Fumoleau P. Glufosfamide administered using a 1-hour infusion given as first-line treatment for advanced pancreatic cancer. A phase II trial of the EORTC-new drug development group. Eur J Cancer. 2003 Nov;39(16):2334-40.

location_country: Denmark Greece Netherlands Switzerland France Israel Germany

location_facility: Herlev Hospital - University Hospital of Copenhagen

location_facility: Haemato-Onkologische Praxis und Tagesklinik

location_facility: Academisch Ziekenhuis der Vrije Universiteit


title: Patterns of Care and Clinical Outcomes of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

acronym: EXTRACT

summary: The main aim is to see how treatment patterns and drugs might improve care for adults with advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon-20 driven mutations. Past medical records will be reviewed. No clinic visits or procedures will be required.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country:
Canada
Hong Kong
France

location_facility: Centre Hospitalier de la Region d'Annecy

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: University Health Network Princess Margaret Cancer Research Tower (PMCRT) The MaRS Centre, East Tower

location_facility: Centre Hospitalier Regional de la Reunion

location_facility: Centre Hospitalier Intercommunal de Creteil

status_simplified: Ongoing


title: A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies

acronym: PLATYPUS

summary:
The purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies [NCT03422328, NCT03904693 and NCT04565990]), to continue to benefit from the intervention after closure of the parent study in case they have no alternative means of access to the study intervention. This study will allow assessment of the long-term safety of each study intervention.

.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Actelion

location_country:
Poland
Taiwan
Romania
Belarus
Russian Federation
Ukraine
Korea, Republic of
India
France
South Africa
Turkey
Belgium
Bulgaria

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: CHU de Montpellier - Arnaud de Villeneuve

location_facility: Centre Hospitalier Universitaire - de Nice - Hopital Pasteur

location_facility: Samara Regional Clinical Cardiological Dispensary

location_facility: The Republican Scientific-Practical Center ''Cardiology''

location_facility: State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

location_facility: Health Care Municipal Institution City Clinical Hospital #13

location_facility: Federal State Budget Scientific Institution

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

location_facility: Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii

location_facility: Wojewodzki Szpital Specjalist, Osrodek Badawczo-Rozwojowy

location_facility: Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Municipal Inst. Of Dnipropetrovsk Region. Council

location_facility: Scientific and Research Institution of Cardiovascular Diseases Complex Problems

location_facility: Klinika Kardiologii z Oddzialem Intensywnego Nadzoru Kardiologicznego, UM w Białymstoku

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

location_facility: Hopital Bicêtre - Aphp Hôpitaux Universitaires Paris-Sud

location_facility: University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

location_facility: Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im. W.Bieganskiego

location_facility: Wojewodzki Szpital Specjalistyczny, Oddzial Kardiologiczny

location_facility: SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im. Prof. Leszka Gieca

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

location_facility: Institutul de pneumoftiziologie Marius Nasta

location_facility: GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel

location_facility: ECZ Otwock Klinika Kardiologii, Klinika Krążenia Płucnego Chorób Zakrzepowo-Zatorowych i Kardiologii


title: A Phase II Open-label Study Evaluating Valemetostat Tosylate as a Single Agent in Patients With Relapse/Refractory B-cell Lymphoma

summary: This is a multicenter, prospective, single arm, non-randomized, open-label, phase 2 clinical study to evaluate safety and efficacy of valemetostat tosylate (DS-3201b) in patients with relapsed or refractory B cell lymphoma with 6 cohorts of patients including 2 biology-driven cohorts. Up to 141 patients will be enrolled in 6 different cohorts (40 patients with aggressive B-cell lymphoma, 41 with follicular lymphoma (FL), 20 with Mantle Cell Lymphoma (MCL) and 20 with other indolent lymphomas, and 20 patients with Hodgkin lymphoma (HL)). FL patients with EZH2 mutant (gain of function mutations) will be enrolled in the cohort 2bis. At least 8 aggressive B-cell lymphoma patients with EZH2 mutant will be enrolled in the cohort 1. The primary endpoint is the overall response rate (ORR) determined by investigator assessment.

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: France Belgium

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: Service des Maladies du Sang - CHRU de Lille


title: Phase III Postneoadjuvant Study Evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in Primary HER2-negative Breast Cancer Patients With High Relapse Risk After Standard Neoadjuvant Treatment - SASCIA

acronym: SASCIA

summary:
Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to:

Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles);
Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation.

Treatment in either arm will be given for eight cycles.

In patients with HR-positive breast cancer, endocrine-based therapy will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents.

lead_sponsor: German Breast Group

location_country: Spain Italy Ireland Switzerland France Belgium Germany

location_facility: Institut de Cancérologie Strasbourg Europe-ICANS

location_facility: Praxisklinik für Hämatologie und Onkologie

location_facility: Centro di Riferimento Oncologico (CRO) - IRCCS

location_facility: Consorci Hospital General Universitari de Valencia

location_facility: Hospital Universitario Quirónsalud Madrid

location_facility: Ico de Badalona (Hospital Universitari Germans Trias I Pujol)

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Klinikum Kassel GmbH, Gynäkologische Ambulanz

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

location_facility: Consorcio Hospitalario Provincial de Castellón

location_facility: MVZ Nordhausen gGmbH im Südharz Krankenhaus

location_facility: Onkologische Schwerpunktpraxis, Studiengesellschaft Onkologie Bielefeld GbR

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: Hospital Clínico Universitario Virgen de La Arrixaca

location_facility: Sozialstiftung Bamberg, Klinik am Bruderwald

location_facility: St. Elisabeth-Krankenhaus, Brustzentrum Köln-Hohenlind

location_facility: Centrum für Hämatologie und Onkologie am Bethanien-Krankenhaus

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Complejo Hospitalario Universitario de Santiago (Chus)

location_facility: Uniklinikum, Klinik für Geburtshilfe und Gynäkologie

location_facility: Gemeinschaftspraxis Dr. U. Kronawitter/ Dr. C. Jung

location_facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung/Knappschaft GmbH

location_facility: Hospital Universitario Virgen de La Macarena

location_facility: Hospital General Universitario de Alicante

location_facility: Gemeinschaftspraxis Dres. Heinrich / Bangerter

location_facility: SRH Wald-Klinikum Gera gGmbH, Brustzentrum Ostthüringen

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Institut de cancérologie de l'ouest (Angers)

location_facility: Charité Universitätsmedizin Campus Charité Mitte

location_facility: Hôpital Privé Des Côtes d'Armor- Centre CARIO-HPCA

location_facility: Complejo Hospitalario Universitario de Albacete

location_facility: Hospital Universitario Ntra.Sra. de Candelaria

location_facility: COMPLEJO HOSPITALARIO UNIVERSITARIO A CORUÑA-Hospital Teresa Herrera (CHUAC)

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Hochwaldkrankenhaus, Gesundheitszentrum Wetterau gGmbH

location_facility: Istituti Clinici Scientifici Maugeri SpA-SB

location_facility: Schwerpunktpraxis der Gynäkologie und Onkologie

location_facility: Complejo Hospitalario Universitario de Orense-Hospital Santa Maria Nai

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Hospital Universitario Fundación Alcorcón


title: Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury

acronym: Epis-AKI

summary:
The evaluation of an accurate occurrence rate for AKI is of great importance for health policy, quality initiatives as well as for designing clinical trials.

The primary objective is to prospectively evaluate the incidence of AKI within 72 h after extended surgical procedures that require admission to an observation unit.

time_perspective: Prospective

ReferenceCitation: Weiss R, Saadat-Gilani K, Kerschke L, Wempe C, Meersch M, Zarbock A; EPIS-AKI Investigators. EPIdemiology of Surgery-Associated Acute Kidney Injury (EPIS-AKI): study protocol for a multicentre, observational trial. BMJ Open. 2021 Dec 30;11(12):e055705. doi: 10.1136/bmjopen-2021-055705.

lead_sponsor: University Hospital Muenster

location_country:
Saudi Arabia
Italy
Russian Federation
Slovenia
Spain
Palestinian Territory, occupied
North Macedonia
United States
France
Libyan Arab Jamahiriya
Malta
Turkey
Germany
Egypt

location_facility: Izmir Democracy University School of Medicine

location_facility: Hospital Universitario Funcacion Alcorcón

location_facility: Suleyman Demirel University School of Medicine

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Health Sciences University Medical School

location_facility: Hospital Cliínico Universitario Virgen de las Nieves

location_facility: Centre de Lutte contre le Cancer Francois Baclesse

location_facility: Cardioanestesia - Azienda Ospedaliera San Carlo di Potenza

location_facility: Bakulev Scientific Center for Cardiovascular Surgery

lead_sponsor_type: academique


title: A Multicenter Open Label Phase II Study of Daratumumab in Combination With Dexamethasone in Multiple Myeloma Resistant or Refractory to Bortezomib and Lenalidomide and Pomalidomide - an IFM 2014-04 Study

lead_sponsor: University Hospital, Lille

location_facility: Onco-hématologie CHRU Hôpital Bretonneau

location_facility: Service Hématologie Centre Hospitalier Yves le Foll

location_facility: Hôpital du Haut Lévêque Centre François Magendie

location_facility: service hématologie CH Bretagne Atlantique

location_facility: Service d'Hématologie Clinique Institut de Cancérologie Lucien Neuwirth

location_facility: Clinique - ICH CHU de Brest Hôpital Morvan

location_facility: Sce Hématologie Thérapie Cellulaire CHU Limoges

location_facility: Unité de Recherche Clinique - CH Périgueux

location_facility: Département d'Hématologie et Oncologie Hôpitaux Universitaires de Strasbourg

location_facility: Médecine interne Centre hospitalier départemental

summary:
This study is a Multicentre, Open-label, Phase II study of Daratumumab and Dexamethasone in MM patients. Eligible patients must have a symptomatic RRMM with a measurable disease, resistant or refractory to Bortezomib and Lenalidomide and Pomalidomide.

There is no dose escalation phase, as the MAxiamal Tolerated Dose (MTD) and drug scheduling have already been determined in previous phase 1-2 dose escalation studies. There is no randomization.


title: A Prospective Phase II Study of Bendamustine in Patients Aged Over 60 Years With Classical Hodgkin Lymphoma Treated by Prednisone, Vinblastine and Doxorubicin

acronym: PVAB

summary: This study evaluates bendamustine in patients aged over 60 years with classical Hodgkin Lymphoma treated by prednisone, vinblastine and doxorubicin. 90 patients will be enrolled in this study.

location_facility: Centre Hospitalier Annecy-Genevois - Site d'Annecy

location_facility: CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie

location_facility: CHR de Metz-Thionville - Hôpital de Mercy

location_facility: CHU de Grenoble - Hôpital Albert Michallon


acronym: CIRCUS

title: Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients

lead_sponsor: Hospices Civils de Lyon

ReferenceCitation: Cung TT, Morel O, Cayla G, Rioufol G, Garcia-Dorado D, Angoulvant D, Bonnefoy-Cudraz E, Guérin P, Elbaz M, Delarche N, Coste P, Vanzetto G, Metge M, Aupetit JF, Jouve B, Motreff P, Tron C, Labeque JN, Steg PG, Cottin Y, Range G, Clerc J, Claeys MJ, Coussement P, Prunier F, Moulin F, Roth O, Belle L, Dubois P, Barragan P, Gilard M, Piot C, Colin P, De Poli F, Morice MC, Ider O, Dubois-Randé JL, Unterseeh T, Le Breton H, Béard T, Blanchard D, Grollier G, Malquarti V, Staat P, Sudre A, Elmer E, Hansson MJ, Bergerot C, Boussaha I, Jossan C, Derumeaux G, Mewton N, Ovize M. Cyclosporine before PCI in Patients with Acute Myocardial Infarction. N Engl J Med. 2015 Sep 10;373(11):1021-31. doi: 10.1056/NEJMoa1505489. Epub 2015 Aug 30.

ReferenceCitation: Bochaton T, Claeys MJ, Garcia-Dorado D, Mewton N, Bergerot C, Jossan C, Amaz C, Boussaha I, Thibault H, Ovize M. Importance of infarct size versus other variables for clinical outcomes after PPCI in STEMI patients. Basic Res Cardiol. 2019 Dec 12;115(1):4. doi: 10.1007/s00395-019-0764-8.

ReferenceCitation: Mewton N, Cung TT, Morel O, Cayla G, Bonnefoy-Cudraz E, Rioufol G, Angoulvant D, Guerin P, Elbaz M, Delarche N, Coste P, Vanzetto G, Metge M, Aupetit JF, Jouve B, Motreff P, Tron C, Labeque JN, Steg PG, Cottin Y, Range G, Clerc J, Coussement P, Prunier F, Moulin F, Roth O, Belle L, Dubois P, Barragan P, Gilard M, Piot C, Colin P, Morice MC, Monassier JP, Ider O, Dubois-Randé JL, Unterseeh T, Lebreton H, Beard T, Blanchard D, Grollier G, Malquarti V, Staat P, Sudre A, Hansson MJ, Elmer E, Boussaha I, Jossan C, Torner A, Claeys M, Garcia-Dorado D, Ovize M; CIRCUS Study Investigators. Rationale and design of the Cyclosporine to ImpRove Clinical oUtcome in ST-elevation myocardial infarction patients (the CIRCUS trial). Am Heart J. 2015 Jun;169(6):758-766.e6. doi: 10.1016/j.ahj.2015.02.020. Epub 2015 Mar 13.

location_country: France Spain Belgium

location_facility: Hôpitaux Universitaires, Nouvel Hôpital Civil

location_facility: Hopital Louis Pradel, Hospices Civils de Lyon

location_facility: Centre Hospitalier Universitaire d'Angers

summary: Infarct size is a major determinant of prognosis after Acute Myocardial Infarction (AMI). The investigators recently reported that cyclosporine A, when administered immediately prior to percutaneous coronary intervention (PCI), can significantly reduce infarct size in STEMI (ST Elevation acute Myocardial Infarction) patients. The objective of the present study is to determine whether cyclosporine can improve STEMI patient clinical outcome. Nine-hundred and seventy two patients with ST elevation MI will be entered into a multicentre, randomized, placebo-controlled, double-blinded study. They will receive one single injection of cyclosporine A (CicloMulsion, verum) or an equivalent volume of placebo prior to reperfusion therapy by PCI. The incidence of the combined endpoint (mortality, hospitalization for heart failure, left ventricular (LV) remodeling) will be assessed at one year and three years after treatment.


type: Registry Identifier

title: A 3 Month Observational Prospective Patient Cohort Study of the Treatment of Breakthrough Pain in Cancer Patients With Instanyl®

acronym: INIS

summary: The aim of this study is to describe the use of Instanyl® (Intranasal fentanyl spray) in the treatment of breakthrough pain (BTP) in cancer patients by success of dose titration and distribution of dose strength. Data will be collected at three different time points over a 3 month period.

location_country:
Denmark
United Kingdom
Ireland
Greece
France
Norway
Sweden


title: Kuvan® Adult Maternal Pediatric European Registry

acronym: KAMPER

summary:
Kuvan® is a synthetic copy of a body's own substance called tetrahydrobiopterin (BH4). BH4 is required by the body to use an amino acid called phenylalanine in order to build another substance called tyrosine.

Kuvan® received marketed authorisation in Europe in December 2008 and is now available in several European countries for the treatment of Hyperphenylalaninemia (HPA).

The primary objective is to assess the long-term safety in subjects treated with Kuvan®.

Secondary objectives are to provide additional information regarding:

Safety in specific subject groups (elderly, pediatric, pregnant women and subjects with renal or hepatic insufficiency).
Growth and neurocognitive outcomes for subjects with hyperphenylalaninemia (HPA) who are receiving treatment with Kuvan®.
Progress and outcome of pregnancy for women with HPA who become pregnant while receiving treatment with Kuvan® (these women will be enrolled in a dedicated sub-registry).
Assessment of adherence to diet and to Kuvan®.
Assessment of long-term sensitivity to Kuvan®treatment.

lead_sponsor: BioMarin Pharmaceutical

location_country: Portugal Spain Italy Austria Netherlands Sweden France Germany Slovakia

location_facility:
Research Site - Policlinico Federico
Research Site - Armand Trousseau
Research Site - Necker
Research Site
Research Site - Ospedale Annunziata


acronym: BIBF 1120 vs Bevacizumab in  CRC

title: A Phase I-II Study of BIBF 1120 and FOLFOX Compared to Bevacizumab and FOLFOX in First Line Metastatic Colorectal Cancer Patients

lead_sponsor: Boehringer Ingelheim

location_country: Spain Italy France Belgium Germany

location_facility: 1199.51.3307B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3306B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.39005 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3306C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34003 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3308E Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3301B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.39001 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.39004 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.39002 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3305A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3306D Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3302A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49008 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3306A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3301D Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49002 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34005 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3302C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3302E Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3301C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3305B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3305E Boehringer Ingelheim Investigational Site

location_facility: 1199.51.39003 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34001 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34006 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3307C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3308A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34004 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49004 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.32006 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3308C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49001 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49003 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.32002 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34007 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3301A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3307A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49006 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3308D Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3308B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.32001 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3302D Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3305D Boehringer Ingelheim Investigational Site

location_facility: 1199.51.32005 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3305C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3302B Boehringer Ingelheim Investigational Site

summary: The primary objective of this study is to evaluate PFS rate at 9 months of BIBF 1120 in combination with mFolfox6 compared with mFolfox6 combined to bevacizumab in first line patients with metastatic colorectal cancer.


title: An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

lead_sponsor: Ferring Pharmaceuticals

ReferenceCitation: Abrahamsson PA, Boccon-Gibod L, Morote J, de Jong IJ, Malmberg A, Neijber A, Albers P. Factors Predicting the Off-treatment Duration in Patients with Prostate Cancer Receiving Degarelix as Intermittent Androgen Deprivation Therapy. Eur Urol Focus. 2017 Oct;3(4-5):470-479. doi: 10.1016/j.euf.2015.12.008. Epub 2016 Jan 22.

ReferenceCitation: Boccon-Gibod L, Albers P, Morote J, van Poppel H, de la Rosette J, Villers A, Malmberg A, Neijber A, Montorsi F. Degarelix as an intermittent androgen deprivation therapy for one or more treatment cycles in patients with prostate cancer. Eur Urol. 2014 Oct;66(4):655-63. doi: 10.1016/j.eururo.2014.05.037. Epub 2014 Jun 18.

location_country: Spain Italy Netherlands France Belgium Germany

location_facility: Complexo Hospitalario Universitario A Coruña (CHUAC)

location_facility: Praxisgemeinschaft f. Onkologie & Urologie

location_facility: Hospital Universitario Principe de Asturias

location_facility: Erasme Hospital, University Clinics of Brussels

location_facility: Gemeinschaftspraxis Dres. Rudolph, Wörner

location_facility: Azienda Policlinico Universitario G. Martino

location_facility: Gemeinschaftspraxis - Tagesklinik Dres. Rulf, Langhorst

summary: The purpose of this uncontrolled, multi-center, open-label trial was to investigate the feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the treatment of prostate cancer.


title: Biventricular Tachycardias Outcome Trial

acronym: BITAC

summary:
This clinical investigation is a device-based open, prospective, multicenter two-arm randomized trial, comparing patients who are treated in the slow VT zone versus patients who are not treated in that zone.

The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and health authorities will be informed prior to any use of a newer device if applicable.

All patients will have a 3-zone detection configuration programmed. The slow VT zone will be defined by programming the detection parameters as follows:

Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we recommend to adjust this parameter to: resting rate + 30 bpm)
VT detection rate: 150 bpm

PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones.

The Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF are also left to the investigator's judgment.

Patients will be randomized at implant to have the slow VT zone programmed as a monitoring zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm). The randomization table will be generated by Sorin Group/ELA Medical.

lead_sponsor: LivaNova

location_country:
Portugal
Spain
Italy
United Kingdom
Canada
Sweden
France
Belgium
Germany

location_facility: Universitatsklinik Med. Klinik Heidelberg


title: Phase III, Multicentre, Randomised, Double-blind, Comparative Study to Assess the Efficacy and Safety of Lanreotide 30 mg Versus Placebo as a Palliative Treatment of Clinical Symptoms Associated With Intestinal Obstruction Due to Peritoneal Carcinomatosis in Inoperable Patients.

summary: The purpose of this study is to determine whether lanreotide 30mg microparticles are effective in the relief of clinical symptoms due to small bowel obstruction in inoperable patients with peritoneal carcinomatosis.

ReferenceCitation: Mariani P, Blumberg J, Landau A, Lebrun-Jezekova D, Botton E, Beatrix O, Mayeur D, Herve R, Maisonobe P, Chauvenet L. Symptomatic treatment with lanreotide microparticles in inoperable bowel obstruction resulting from peritoneal carcinomatosis: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol. 2012 Dec 10;30(35):4337-43. doi: 10.1200/JCO.2011.40.5712. Epub 2012 Oct 29.

lead_sponsor: Ipsen

location_country: Netherlands France Belgium

location_facility: Centre de Radiothérapie et Oncologie Médicale

intervention_type: Other


title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter, Proof of Concept and Dose-Finding Phase II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of ADRECIZUMAB in Patients With Septic Shock and Elevated Adrenomedullin

summary: This is a double-blind, placebo-controlled, randomized, multicenter proof of concept and dose-finding phase II study using two doses of ADRECIZUMAB in patients with early septic shock and a bio-ADM plasma concentration at admission of > 70 pg/ml.

ReferenceCitation: Laterre PF, Pickkers P, Marx G, Wittebole X, Meziani F, Dugernier T, Huberlant V, Schuerholz T, François B, Lascarrou JB, Beishuizen A, Oueslati H, Contou D, Hoiting O, Lacherade JC, Chousterman B, Pottecher J, Bauer M, Godet T, Karakas M, Helms J, Bergmann A, Zimmermann J, Richter K, Hartmann O, Pars M, Mebazaa A; AdrenOSS-2 study participants. Safety and tolerability of non-neutralizing adrenomedullin antibody adrecizumab (HAM8101) in septic shock patients: the AdrenOSS-2 phase 2a biomarker-guided trial. Intensive Care Med. 2021 Nov;47(11):1284-1294. doi: 10.1007/s00134-021-06537-5. Epub 2021 Oct 4.

ReferenceCitation: Geven C, Blet A, Kox M, Hartmann O, Scigalla P, Zimmermann J, Marx G, Laterre PF, Mebazaa A, Pickkers P. A double-blind, placebo-controlled, randomised, multicentre, proof-of-concept and dose-finding phase II clinical trial to investigate the safety, tolerability and efficacy of adrecizumab in patients with septic shock and elevated adrenomedullin concentration (AdrenOSS-2). BMJ Open. 2019 Feb 19;9(2):e024475. doi: 10.1136/bmjopen-2018-024475.

lead_sponsor: Adrenomed AG

location_country: Germany France Netherlands Belgium

location_facility: Universitätsmedizin Rostock Klinik und Poliklinik für Anästhesiologie und Intensivtherapie

location_facility: Universitätsklinikum Hamburg-Eppendorf Klinik für Intensivmedizin

location_facility: CHU de Nantes; Medicine Intensive Reanimation

location_facility: University Hospital of Clermont-Ferrand, Dept. of Perioperative Medicine

location_facility: Groupe Jolimont, Hospitalier de Jolimont

location_facility: CHRU Bretonneau, Medecine Intensive Réanimation

location_facility: Clinique Universitaire Saint-Luc (UCL Bruxelles)

location_facility: Universitätsklinikum Münster Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie

location_facility: Hôpital Lariboisière, Dept. d'Anesthesie

location_facility: Universitätsklinikum Aachen, Klinik für Operative Intensivmedizin

location_facility: Hôpital Lariboisière, Réanimation Médicale et Traumatologique

location_facility: Universitätsklinikum Jena Klinik für Anästhesiologie und Intensivmedizin

location_facility: Canisius-Wilhelmina-Ziekenhuis (CWZ), Intensive Care

location_facility: Zuyderland Medical Center, Department of Intensive Care

location_facility: Hôpital de Hautepierre , Hôpitaux Universitaires de Strasbourg, Unité de Réanimation Chirurgicale, Service d'Anesthésie-Réanimation Chirurgicale

location_facility: Gelderse Vallei Hospital, Department of Intensive Care

location_facility: Medisch Spectrum Twente, Department of Intensive Care

location_facility: AP-HP, Hopital Louis Mourier, Réanimation Médicale

location_facility: Hôpital Européen Georges Pompidou, Service d'Anesthésie-Réanimation Chirurgicale, Université Paris Descartes

location_facility: Medical Intensive Care Medicine, Centre hospital - universitaire

location_facility: Hôpital de Bicêtre, Service d'anesthésie-réanimation chirurgicale

location_facility: Antwerp University Hospital (UZA), Critical Care Medicine

location_facility: Hôpital Saint-Louis, Service d'Anesthésie-Réanimation


acronym: BI 6727 randomised phase II trial in ovarian cancer

title: Phase II Randomized Trial of the Polo-like Kinase 1 Inhibitor BI 6727 Monotherapy Versus Investigator´s Choice Chemotherapy in Ovarian Cancer Patients Resistant or Refractory to Platinum-based Cytotoxic Therapy

ReferenceCitation: Pujade-Lauraine E, Selle F, Weber B, Ray-Coquard IL, Vergote I, Sufliarsky J, Del Campo JM, Lortholary A, Lesoin A, Follana P, Freyer G, Pardo B, Vidal L, Tholander B, Gladieff L, Sassi M, Garin-Chesa P, Nazabadioko S, Marzin K, Pilz K, Joly F. Volasertib Versus Chemotherapy in Platinum-Resistant or -Refractory Ovarian Cancer: A Randomized Phase II Groupe des Investigateurs Nationaux pour l'Etude des Cancers de l'Ovaire Study. J Clin Oncol. 2016 Mar 1;34(7):706-13. doi: 10.1200/JCO.2015.62.1474. Epub 2016 Jan 11.

location_country: Spain France Belgium Sweden Slovakia

location_facility: 1230.18.46001 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34007 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3314A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.32002 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34003 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3305A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34006 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3310A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34004 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3313A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3322A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.42101 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3321A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3315A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3311A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.42103 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3320A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.32001 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.32003 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.46003 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34001 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3312A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.32004 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.46005 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3308A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34005 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3301A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34002 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3302A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3307A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3309A Boehringer Ingelheim Investigational Site

summary:
This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer.

100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50 patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be continued until disease progression or unacceptable toxicity. Primary endpoint: disease control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1.

Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour response, biological progression free survival assessed by serum CA 125 according to Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms questionnaires, pharmacokinetics of BI 6727.

Others endpoints: biomarkers and pharmacogenetics analysis (optional)


title: Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)

acronym: TRacKING

summary:
This registry will make it possible to describe real life management of patients with rare actionable fusions and to better understand these cancers. In addition of clinical data from the medical files, a quality of life questionnaire (QLQ-C30) will be complete at inclusion, at each new treatment and then every 6 months. The patients will be followed for a period of at least 2 years after the inclusion.

This TRacKING registry is a European collaborative tool to improve the management of patients with actionable fusions, by sharing of data from rare tumor indications.

lead_sponsor: Centre Leon Berard

location_country:
Denmark
Poland
Slovenia
Italy
Austria
Netherlands
Spain
United Kingdom
France
Germany
Czechia

location_facility: "Medizinische Klinik 1- Gastroenterologie, Hepatologie, Pneumologie Universitätsklinikum Frankfurt"

location_facility: "Hämato-Onkologischer Studienkreis MVZ am Klinikum Aschaffenburg / Onkologie"

location_facility: Azienda Ospedaliera - Universitaria - Policlinico S Orsola-Malpighi Univertsita di Bologna

location_facility: Complejo Hospitalario regional Virgen del Rocio

location_facility: University Hospital Würzburg (UniversitätsKlinikum Würzburg)

location_facility: "Klinik für Innere Medizin III, Hämatologie, Onkologie Südharzklinikum"

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: "Hämatologisch-onkologische Ambulanz Universitätsklinikum Halle"

location_facility: "Medizinische Klinik und Poliklinik III LMU - Klinikum der Universität München"

location_facility: "Klinik für Innere Medizin III, Hämatologie, Onkologie Klinikum Chemnitz"

location_facility: Universitätsklinikum Tübingen Medizinische Universitätsklinik;

location_facility: Maria Sklodowska Curie National Research Institute of Oncology

location_facility: "Klinik für Gastroenterologie, Hepatologie und Infekt Universitätsklinikum Magdeburg"

location_facility: Azienda Ospedaliero - Universitaria Cita della Salute e della Scienza di Torino

location_facility: Mannheim University Medical Center (UniversitatsMedizin Mannheim)

location_facility: Masaryk Memorial Cancer Institute (Masarykuv Onkologicky Ustav)

location_facility: University College London NHS Foundation Trust

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Assistance Publique Hopitaux de Marseille (AP-HM)


acronym: POLAR

title: A Phase III Open-label, Multicenter, Randomized Trial of Adjuvant Palbociclib in Combination With Endocrine Therapy Versus Endocrine Therapy Alone for Patients With Hormone Receptor Positive / HER2-negative Resected Isolated Locoregional Recurrence of Breast Cancer

lead_sponsor: ETOP IBCSG Partners Foundation

ReferenceCitation: Anderson SJ, Wapnir I, Dignam JJ, Fisher B, Mamounas EP, Jeong JH, Geyer CE Jr, Wickerham DL, Costantino JP, Wolmark N. Prognosis after ipsilateral breast tumor recurrence and locoregional recurrences in patients treated by breast-conserving therapy in five National Surgical Adjuvant Breast and Bowel Project protocols of node-negative breast cancer. J Clin Oncol. 2009 May 20;27(15):2466-73. doi: 10.1200/JCO.2008.19.8424. Epub 2009 Apr 6.

ReferenceCitation: Wapnir IL, Aebi S, Geyer CE, Zahrieh D, Gelber RD, Anderson SJ, Robidoux A, Bernhard J, Maibach R, Castiglione-Gertsch M, Coates AS, Piccart MJ, Clemons MJ, Costantino JP, Wolmark N; IBCSG; BIG; NSABP. A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse of breast cancer: IBCSG 27-02, BIG 1-02, and NSABP B-37. Clin Breast Cancer. 2008 Jun;8(3):287-92. doi: 10.3816/CBC.2008.n.035.

ReferenceCitation: Borner M, Bacchi M, Goldhirsch A, Greiner R, Harder F, Castiglione M, Jungi WF, Thürlimann B, Cavalli F, Obrecht JP, et al. First isolated locoregional recurrence following mastectomy for breast cancer: results of a phase III multicenter study comparing systemic treatment with observation after excision and radiation. Swiss Group for Clinical Cancer Research. J Clin Oncol. 1994 Oct;12(10):2071-7.

ReferenceCitation: Aebi S, Gelber S, Anderson SJ, Láng I, Robidoux A, Martín M, Nortier JW, Paterson AH, Rimawi MF, Cañada JM, Thürlimann B, Murray E, Mamounas EP, Geyer CE Jr, Price KN, Coates AS, Gelber RD, Rastogi P, Wolmark N, Wapnir IL; CALOR investigators. Chemotherapy for isolated locoregional recurrence of breast cancer (CALOR): a randomised trial. Lancet Oncol. 2014 Feb;15(2):156-63. doi: 10.1016/S1470-2045(13)70589-8. Epub 2014 Jan 16.

ReferenceCitation: Wapnir IL, Price KN, Anderson SJ, Robidoux A, Martín M, Nortier JWR, Paterson AHG, Rimawi MF, Láng I, Baena-Cañada JM, Thürlimann B, Mamounas EP, Geyer CE Jr, Gelber S, Coates AS, Gelber RD, Rastogi P, Regan MM, Wolmark N, Aebi S; International Breast Cancer Study Group; NRG Oncology, GEICAM Spanish Breast Cancer Group, BOOG Dutch Breast Cancer Trialists' Group; Breast International Group. Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial. J Clin Oncol. 2018 Apr 10;36(11):1073-1079. doi: 10.1200/JCO.2017.76.5719. Epub 2018 Feb 14.

ReferenceCitation: Migliaccio I, Di Leo A, Malorni L. Cyclin-dependent kinase 4/6 inhibitors in breast cancer therapy. Curr Opin Oncol. 2014 Nov;26(6):568-75. doi: 10.1097/CCO.0000000000000129. Review.

ReferenceCitation: Wardell SE, Ellis MJ, Alley HM, Eisele K, VanArsdale T, Dann SG, Arndt KT, Primeau T, Griffin E, Shao J, Crowder R, Lai JP, Norris JD, McDonnell DP, Li S. Efficacy of SERD/SERM Hybrid-CDK4/6 Inhibitor Combinations in Models of Endocrine Therapy-Resistant Breast Cancer. Clin Cancer Res. 2015 Nov 15;21(22):5121-5130. doi: 10.1158/1078-0432.CCR-15-0360. Epub 2015 May 19.

ReferenceCitation: Finn RS, Crown JP, Lang I, Boer K, Bondarenko IM, Kulyk SO, Ettl J, Patel R, Pinter T, Schmidt M, Shparyk Y, Thummala AR, Voytko NL, Fowst C, Huang X, Kim ST, Randolph S, Slamon DJ. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015 Jan;16(1):25-35. doi: 10.1016/S1470-2045(14)71159-3. Epub 2014 Dec 16.

ReferenceCitation: Turner NC, Huang Bartlett C, Cristofanilli M. Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2015 Oct 22;373(17):1672-3. doi: 10.1056/NEJMc1510345.

location_country: Spain Italy Austria Switzerland Hungary France

location_facility: Instituto Catalan de Oncologia L´Hospitalet

location_facility: Groupe hospitalier de Bretagne Sud, Hôpital du Scorff

location_facility: Istituto scientifico Romagnolo per lo studio e la cura

location_facility: Hospital General Universitario de Alicante

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: MUW - Universitätsklinik für Innere Medizin

location_facility: Medizinische Universität Innsbruck - Univ.-Klinik f. Frauenheilkunde

location_facility: AOU Maggiore Della Carita, University of Eastern Piedmont

location_facility: Centre Hospitalier Universitaire de Limoges

summary:
POLAR is a phase III clinical trial, which will test the safety and efficacy of an investigational combination of drugs to learn whether the combination of drugs works for a specific cancer. Palbociclib (Ibrance®) is the name of the investigational agent, which is assessed together with standard anti-hormone therapy in this study. Palbociclib is used to treat patients with hormone receptor-positive / HER2-negative breast cancer which has spread beyond the original tumor and/or to other organs.

During this study, anti-hormone therapy will consist of either a selective estrogen receptor modulator (such as tamoxifen) or an aromatase inhibitor (anastrozole, letrozole, exemestane) or fulvestrant (Faslodex®). Premenopausal women and men may also receive a drug called an LHRH (luteinizing hormone-releasing hormone) agonist by injection.

It is standard of care for people with hormone receptor positive breast cancer to take anti-hormone therapy. The study doctor will determine the type of standard anti-hormone therapy that will be given during this trial.

The purpose of the POLAR study is to compare the effect of using 3 years of palbociclib in combination with standard anti-hormone therapy with standard anti-hormone therapy alone and to evaluate the time until the breast cancer returns, if it does return.


title: Optimising Outpatient Care in Mild to Moderate Psoriasis by a Newly Developed 'Topical Treatment Optimising Programme' - an International Study Using Daivobet®/Dovobet® Gel

acronym: PSO-TOP

summary: A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board to overcome non-adherence problems.

ReferenceCitation: Reich K, Zschocke I, Bachelez H, de Jong EM, Gisondi P, Puig L, Warren RB, Mrowietz U; TTOP study group. Efficacy of a fixed combination of calcipotriol/betamethasone dipropionate topical gel in adult patients with mild to moderate psoriasis: blinded interim analysis of a phase IV, multicenter, randomized, controlled, prospective study. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1156-63. doi: 10.1111/jdv.12774. Epub 2014 Oct 26.

ReferenceCitation: Reich K, Mrowietz U, Karakasili E, Zschocke I. Development of an adherence-enhancing intervention in topical treatment termed the topical treatment optimization program (TTOP). Arch Dermatol Res. 2014 Sep;306(7):667-76. doi: 10.1007/s00403-014-1475-5. Epub 2014 Jun 4.

ReferenceCitation: Zschocke I, Mrowietz U, Lotzin A, Karakasili E, Reich K. Assessing adherence factors in patients under topical treatment: development of the Topical Therapy Adherence Questionnaire (TTAQ). Arch Dermatol Res. 2014 Apr;306(3):287-97. doi: 10.1007/s00403-014-1446-x. Epub 2014 Feb 8.

ReferenceCitation: Reich K, Zschocke I, Bachelez H, de Jong EMGJ, Gisondi P, Puig L, Warren RB, Ortland C, Mrowietz U; PSO-TOP study group. A Topical Treatment Optimization Programme (TTOP) improves clinical outcome for calcipotriol/betamethasone gel in psoriasis: results of a 64-week multinational randomized phase IV study in 1790 patients (PSO-TOP). Br J Dermatol. 2017 Jul;177(1):197-205. doi: 10.1111/bjd.15466. Epub 2017 Jun 6.

lead_sponsor: Kristian Reich, MD

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
Sweden
France
Germany


title: Exploratory Evaluation of Imiquimod 5% Cream in the Treatment of External Genital or Perianal Warts in HIV+ Patients Treated With HAART (CD4+ ≥ 200 Cells mm3): An Open Labeled, Non-comparative Study

summary: Imiquimod 5% cream in the treatment of external genital or perianal warts in HIV+ patients

ReferenceCitation: Saiag P, Bauhofer A, Bouscarat F, Aquilina C, Ortonne JP, Dupin N, Mougin C. Imiquimod 5% cream for external genital or perianal warts in human immunodeficiency virus-positive patients treated with highly active antiretroviral therapy: an open-label, noncomparative study. Br J Dermatol. 2009 Oct;161(4):904-9. doi: 10.1111/j.1365-2133.2009.09210.x. Epub 2009 May 15.

lead_sponsor: MEDA Pharma GmbH & Co. KG

location_facility: Service de Dermatologie Groupe Hospitalier Bichat Claude Bernard

location_facility: Service de Dermatologie Hôpital de l'Archet II

location_facility: Départment de Gynécologie-Obstétrique CHU Saint-Pierre

location_facility: Service de Dermatologie Centre Hospitalier de Valence

location_facility: Service de Dermatologie, Hôpital Ambroise Paré

location_facility: Service Dermatologie C.H. François Rabelais (César de Paepe)

location_facility: Service Dermatologie Hopital COCHIN - Pavillon Tarnier

location_facility: Service de Dermatologie Groupe Hospitalier La Grave

location_facility: Service de Maladies Infectieuses Hôpital de la Conception

location_facility: Service de Dermatologie et Vénéréologie Hôpital Saint Jacques

location_facility: Service de Dermatologie CHU Saint-Pierre


acronym: IROCAS

title: A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for High-risk Stage III Colon Cancer in Adjuvant Setting

lead_sponsor: UNICANCER

ReferenceCitation: Bennouna J, André T, Campion L, Hiret S, Miglianico L, Mineur L, Touchefeu Y, Artru P, Asmis T, Bouché O, Borde F, Kavan P, Lam YH, Rajpar LS, Emile JF, Jouffroy C, Gill S, Taïeb J. Rationale and Design of the IROCAS Study: Multicenter, International, Randomized Phase 3 Trial Comparing Adjuvant Modified (m) FOLFIRINOX to mFOLFOX6 in Patients With High-Risk Stage III (pT4 and/or N2) Colon Cancer-A UNICANCER GI-PRODIGE Trial. Clin Colorectal Cancer. 2019 Mar;18(1):e69-e73. doi: 10.1016/j.clcc.2018.09.011. Epub 2018 Oct 19.

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

location_country: Canada France

location_facility: Centre hospitalier de l'Université de Montréal

location_facility: Hospices civils de Lyon - Hôpital Edouard Herriot

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

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

location_facility: The PEI Cancer Treatment Centre Queen Elizabeth Hospital

summary: The trial is a phase III, multicenter, open-labeled randomized trial comparing the association 5-fluorouracil (5-FU), folinic acid, irinotecan and oxaliplatin (mFOLFIRINOX) versus oxaliplatin, folinic acid, 5-FU (mFOLFOX 6) chemotherapy protocols in patients with high-risk stage III colon cancer in the adjuvant setting.


title: A Prospective Observational Study Cohort to Assess the Rate of Castration Resistance, Disease Progression and Overall Survival Over a 3-year Period Post-androgen Deprivation Therapy Induction in Patients With Advanced Prostate Cancer Who Have Previously Participated in the Triptocare Study (Http://Clinicaltrials.Gov/ct2/Show/Study/NCT01020448)

acronym: TRIPTOCARE LT

summary: The purpose of the protocol is to assess the rate of castration resistance, disease progression and overall survival over a 3-year period post-androgen deprivation therapy (ADT) induction in a study cohort of patients with advanced disease.

location_country:
Denmark
United Kingdom
Latvia
Lithuania
France
Romania
Netherlands

location_facility:
Bristol Royal Infirmary
Oncomed
Sc E-Uro Srl
CHU Henri Mondor
Hôpital Val de Grâce
Hôpital Nord
University Hospital Wales
P.Stradins Clinical University Hospital
Hôpital Pellegrin
Clinique Beau Soleil
Leicester General Hospital
Institut Mutualiste Monsouris
Ulster hospital
Fredericia Sygehus
Hôpital Henry Gabrielle
Diaconessenhuis
Odense Universitets Hospital
University Hospital
CHU Pasteur
Private practice
University Hospital Coventry
Chru Lille
CHU Nantes
Frederiksbergs Hospital
Addenbrookes Hospital
Hôpital Foch
Herlev University Hospital
University Oncological Institute
Lister Hospital
Academisch Medisch Centrum
Medical Center
Center of Oncology
Nottingham City Hospital
Clinique Rhône Durance
Medical University Clinics


title: A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.

acronym: MUSIC

summary: The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.

ReferenceCitation: Colombel JF, Sandborn WJ, Allez M, Dupas JL, Dewit O, D'Haens G, Bouhnik Y, Parker G, Pierre-Louis B, Hébuterne X. Association between plasma concentrations of certolizumab pegol and endoscopic outcomes of patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Mar;12(3):423-31.e1. doi: 10.1016/j.cgh.2013.10.025. Epub 2013 Nov 1.

ReferenceCitation: Hébuterne X, Lémann M, Bouhnik Y, Dewit O, Dupas JL, Mross M, D'Haens G, Mitchev K, Ernault É, Vermeire S, Brixi-Benmansour H, Moreels TG, Mary JY, Marteau P, Colombel JF. Endoscopic improvement of mucosal lesions in patients with moderate to severe ileocolonic Crohn's disease following treatment with certolizumab pegol. Gut. 2013 Feb;62(2):201-8. doi: 10.1136/gutjnl-2012-302262. Epub 2012 Apr 23.

lead_sponsor: UCB Pharma

location_country: Germany France Belgium


title: Prospective Registry for Patients Undergoing Artificial Urinary Sphincter (AUS) Surgery for Female Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency (ISD)

acronym: VENUS

summary: Prospective collection of pre-defined parameters of AUS Surgery for Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency

ipd_sharing: Undecided

ipd_sharing_description: Investigators may share pseudonymised individual data with residents/urologist interested to analyze and publish the results of the registry

lead_sponsor: European Association of Urology Research Foundation

location_country:
Spain
United Kingdom
France
Belgium
Germany
Czechia

location_facility: University of Rennes, Department of Urology


acronym: SEPCELL

title: A Phase Ib/IIa, Randomised, Double Blind, Parallel Group, Placebo Controlled, Multicentre Study to Assess the Safety and Efficacy of Expanded Cx611 Allogeneic Adipose-derived Stem Cells (eASCs) for the Intravenous Treatment of Adult Patients With Severe Community-acquired Bacterial Pneumonia and Admitted to the Intensive Care Unit

lead_sponsor: Tigenix S.A.U.

ReferenceCitation: Laterre PF, Sanchez-Garcia M, van der Poll T, de la Rosa O, Cadogan KA, Lombardo E, Francois B. A phase Ib/IIa, randomised, double-blind, multicentre trial to assess the safety and efficacy of expanded Cx611 allogeneic adipose-derived stem cells (eASCs) for the treatment of patients with community-acquired bacterial pneumonia admitted to the intensive care unit. BMC Pulm Med. 2020 Nov 25;20(1):309. doi: 10.1186/s12890-020-01324-2.

location_country: Spain Italy Lithuania France Belgium Norway

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: St. Olavs Hospital, Department of Intensive care Clinical Immunology and Infectious Disease

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: Centre Hospitalier Universitaire de Limoges - CHU Dupuytren

location_facility: Azienda Ospedaliera San'Andrea. UOC Anestesia e Terapia Intensiva

location_facility: Klaipėda Republican Hospital, The Pulmonology and Allergology Department

location_facility: Centre Hospitalier Départemental les Oudairies

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Departemental les Ouidairies

location_facility: Hospital Clínic I Provincial de Barcelona

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

summary:
The purpose of this randomised, multicentre, double-blind, placebo-controlled, phase Ib/IIa study is to assess the safety, tolerability and efficacy of eASCs (Cx611) administered intravenously as adjunctive therapy, therefore in addition to standard of care (SoC) therapy, to patients with severe community-acquired bacterial pneumonia (sCABP).

The completion of this study will contribute to the basic knowledge on stem cells and their mode-of-action, and has a large translational character, i.e. to document the safety and explore the efficacy of Cx611 in patients with sCABP.


title: A Phase III Study of the Efficacy and Safety of 3APS as Add-on Therapy in Mild to Moderate Alzheimer's Disease

summary: The purpose of this Phase 3 study is to evaluate the efficacy and safety of 3APS as an add-on therapy to most standard medication for Alzheimer's disease compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimer's disease.

status: Unknown status

lead_sponsor: Bellus Health Inc

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

location_facility: Memory Clinic - Neuropsychology Center - University Hospital

location_facility: Memory Assessment Centre - Moorgreen Hospital

location_facility: Fundaciò ACE- Institut Català de Neurociències Aplicades

location_facility: IRCCS Centro San Giovanni di Dio- Fatebenefratelli

location_facility: Johann-Wolfgang Goethe-Universität - Klinik für Psychiatrie und Psychotherapie

location_facility: Hospital Universitario Ramón y Cajal - Unidad de Geriatria

location_facility: Hospital del Mar- Servicio de Neurologia

location_facility: Memory Clinic -Geriatric Centre - Academic Hospital

location_facility: Hôpital Sainte Marguerite Service de neuro-geriatrie

location_facility: Enheten för klinisk Läkemedelsforskning - Minnesmottagningen - Karolinska Universitetssjukhuset - Huddinge

location_facility: Hôpital Gui de Chauliac - Service de Neurologie du Pr J. Touchon

location_facility: Wales College of Medicine - Llandough Hospital

location_facility: University Hospital Antwerp - Neurology - Prof. Dr. Patrick Cras, MD, PhD

location_facility: Neuropsychiatric Clinic - University Hospital MAS

location_facility: Memory Clinic University Hospital Gasthuisberg, Neurology Department

location_facility: Psychiatrische Universitätsklinik Heidelberg - Sektion für Gerontopsychiatrie - Gedächtnisambulanz

location_facility: Hôpital Hôtel Dieu - Consultation de Gérontologie

location_facility: Glasgow Memory Clinic - Golden Jubilee National Hospital

location_facility: Klinik für Psychiatrie und Psychotherapie - University Hospital Hamburg-Eppendorf - Dept. of Psychiatry and Psychotherapy

location_facility: Charité Campus Benjamin Franklin - Universitätsmedizin Berlin - Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie

location_facility: Centre Mémoire de Ressources et de Recherche Hôpital Pasteur

location_facility: Research Institute for Care of Elderly - St Martin's Hospital

location_facility: San Martino Hospital - Padiglione Specialita' Fondi

location_facility: Dept. of Neurology and Alzheimer Center - Vrije Universiteit Medical Center

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Abteilung für Geriatrische Psychiatrie - Zentralinstitut für seelische Gesundheit - Universität Heidelberg

location_facility: Memory Centre, Polycliniques Brull, CHU de Liège

location_facility: Unitat de Valoració de la Memòria i les Demències - Hospital Santa Caterina - Institut d'Assistència Sanitària

location_facility: Memory Clinic UMC St Radboud - Alzheimer Centre

location_facility: CHU Reims- Hôpital Sébastopol-Service de médecine interne et Gérontologie Clinique

location_facility: Dept. of Neurosciences TCR - University of Modena and Reggio Emilia

location_facility: Hospital Santa Creu i Sant Pau, Servicio de Neurología, Unitad de Memoria

location_facility: Department of Neuroscience - Section of Neurology - University of Pisa

location_facility: Kingshill Research Centre - Victoria Hospital


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of the Efficacy and Safety of 2 Doses of Lenalidomide Versus Placebo in Red Blood Cell (RBC) Transfusion-Dependent Subjects With Low- or Intermediate-1-Risk Myelodysplastic Syndromes Associated With a Deletion (Del) 5q[31] Cytogenetic Abnormality

summary: The purpose of this study was to compare 2 doses (10 mg and 5 mg) of lenalidomide to that of placebo in subjects with red blood cell (RBC) transfusion-dependent low- or intermediate-1-risk IPSS MDS associated with a deletion (del) 5q[31] cytogenetic abnormality. Study participants were randomized to one of the two treatment groups or to placebo and took the study drug for 16 weeks. At this timepoint, participants were evaluated for erythroid response. If participants did not achieve at least a minor erythroid response, they were discontinued from the Double-Blind phase and entered into the Open-Label phase. All erythroid responders at Week 16 were to continue in the Double-Blind phase for up to 52 weeks. For participants that were still responding at the end of Double-Blind phase, they could then rollover into the Open-Label phase for an additional two years. Participants could remain on study for up to a total of 3 years. All participants who discontinued from the study were followed every 4 months for overall survival and progression to acute myeloid leukemia (AML).

ReferenceCitation: Fenaux, Pierre, Giagounidis, Aristotle, Selleslag, Dominik, Beyne-Rauzy, Odile, Mufti, Ghulam J, Mittelman, Moshe, Muus, Petra, te Boekhorst, Peter, Sanz, Guillermo, del Canizo, Consuelo, Guerci-Bresler, Agnes, Schlegelberger, Brigitte, Aul, Carlo, Kreipe, Hans, Goehring, Gudrun, Knight, Robert, Francis, John, Fu, Tommy, Hellstrom-Lindberg, Eva. RBC Transfusion Independence and Safety Profile of Lenalidomide 5 or 10 mg in Pts with Low- or Int-1-Risk MDS with Del5q: Results From a Randomized Phase III Trial (MDS-004). ASH Annual Meeting Abstracts 2009 114: 944.

ReferenceCitation: Fenaux, P., Giagounidis, A., Selleslag, D. L., Beyne-Rauzy, O., Mittelman, M., Muus, P., Knight, R. D., Fu, T., Hellstrom-Lindberg, E., The MDS-004 Len del(5q) Study Group. Safety of lenalidomide (LEN) from a randomized phase III trial (MDS-004) in low-/int-1-risk myelodysplastic syndromes (MDS) with a del(5q) abnormality. J Clin Oncol (Meeting Abstracts) 2010 28: 6598

ReferenceCitation: Fenaux, P., Giagounidis, A., Selleslag, D., Knight, R., Fu, T., Hellström-Lindberg, E. Effect of baseline EPO and prior erythropoiesis stimulating agents on RBC transfusion independence in Low-/Int-1-Risk MDS with del 5q treated with lenalidomide: A randomized phase 3 study (MDS-004). Haematologica 2010; 95[suppl.2]:125, abs. 0311.

ReferenceCitation: Brandenburg, N., Fu, T., Revicki, D., Knight, R., Muus, P., Fenaux, P. Impact of lenalidomide on health-related quality of life in patients with RBC transfusion-dependent low- or int-1-risk myelodysplastic syndromes with del 5q: a randomized Phase 3 study (MDS-004). Haematologica 2010; 95[suppl.2]:127, abs. 0316

ReferenceCitation: Fenaux, P., Giagounidis, A., Beyne-Rauzy, O., Mufti, G., Mittelman, M., Muus, P., te Boekhorst, P., Sanz, G., Cazzola, M., Backstrom, J., Fu, T., Hellström-Lindberg, E. Prognostic Factors of Long-Term Outcomes In Low- or Int-1-Risk MDS with del5q Treated with Lenalidomide (LEN): Results From a Randomized Phase 3 Trial (MDS-004). Blood ASH Annual Meeting Abstracts 2010 116:21 abs. 4027.

ReferenceCitation: Brandenburg, N., Yu, R., Revicki, D. Reliability and Validity of the FACT-AN In Patients with Low or Int-1-Risk Myelodysplastic Syndromes with Deletion 5q. Blood ASH Annual Meeting Abstracts 2010 116:21 abs. 3827.

ReferenceCitation: Fenaux P, Giagounidis A, Selleslag D, Beyne-Rauzy O, Mittelman M, Muus P, Nimer SD, Hellström-Lindberg E, Powell BL, Guerci-Bresler A, Sekeres MA, Deeg HJ, Del Cañizo C, Greenberg PL, Shammo JM, Skikne B, Yu X, List AF. Clinical characteristics and outcomes according to age in lenalidomide-treated patients with RBC transfusion-dependent lower-risk MDS and del(5q). J Hematol Oncol. 2017 Jun 26;10(1):131. doi: 10.1186/s13045-017-0491-2.

ReferenceCitation: Saft L, Karimi M, Ghaderi M, Matolcsy A, Mufti GJ, Kulasekararaj A, Göhring G, Giagounidis A, Selleslag D, Muus P, Sanz G, Mittelman M, Bowen D, Porwit A, Fu T, Backstrom J, Fenaux P, MacBeth KJ, Hellström-Lindberg E. p53 protein expression independently predicts outcome in patients with lower-risk myelodysplastic syndromes with del(5q). Haematologica. 2014 Jun;99(6):1041-9. doi: 10.3324/haematol.2013.098103. Epub 2014 Mar 28.

ReferenceCitation: Fenaux P, Giagounidis A, Selleslag D, Beyne-Rauzy O, Mufti G, Mittelman M, Muus P, Te Boekhorst P, Sanz G, Del Cañizo C, Guerci-Bresler A, Nilsson L, Platzbecker U, Lübbert M, Quesnel B, Cazzola M, Ganser A, Bowen D, Schlegelberger B, Aul C, Knight R, Francis J, Fu T, Hellström-Lindberg E; MDS-004 Lenalidomide del5q Study Group. A randomized phase 3 study of lenalidomide versus placebo in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with del5q. Blood. 2011 Oct 6;118(14):3765-76. doi: 10.1182/blood-2011-01-330126. Epub 2011 Jul 13.

ReferenceCitation: Göhring G, Giagounidis A, Büsche G, Hofmann W, Kreipe HH, Fenaux P, Hellström-Lindberg E, Schlegelberger B. Cytogenetic follow-up by karyotyping and fluorescence in situ hybridization: implications for monitoring patients with myelodysplastic syndrome and deletion 5q treated with lenalidomide. Haematologica. 2011 Feb;96(2):319-22. doi: 10.3324/haematol.2010.026658. Epub 2010 Nov 25.

lead_sponsor: Celgene Corporation

location_country:
Spain
Italy
United Kingdom
Netherlands
Sweden
France
Israel
Belgium
Germany

location_facility: Central Manchester and Manchester Children's University Hospitals NHS Trust

location_facility: Centre Jean Bernhard Service Onco-Hematologie

location_facility: SU/Sahlgrenska Section of Hematology & Coagulation

location_facility: John Radcliffe Hospital and the Weatherall Institute of Molecular Medicine

location_facility: CHU Purpan, Place du Dr Baylac, Pavillon des Médecines

location_facility: CHU Purpan, Place du Dr. Baylac, Pavillion des Medecines

location_facility: University of Pavia Division of Hematology

location_facility: CHU d'Angers Service des Maladies du Sang

location_facility: University Hospital of Wales, Dept of Haematology

location_facility: Centre Henri Becquerel Service d'Hematologie Clinique

location_facility: Korolinska Institutet Department of Hematology

location_facility: CHU Nancy Hematologie et Medecine interne

location_facility: Department of Medicine University Hospital

location_facility: CHU Nantes Hematologie et Medicine interne


title: Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure

summary: Study to examine the safety and effectiveness of implanted skeletal muscle cells (cells removed from the thigh muscle) into scarred areas of heart muscle after heart attack.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
United Kingdom
Italy
Switzerland
France
Belgium
Germany


title: Safety and Performance Evaluation of the AccuCinch® Ventricular Restoration System for the Treatment of Heart Failure With or Without Functional Mitral Regurgitation Due to Dilated Ischemic or Non-Ischemic Cardiomyopathy - The CorCinch-EU Study

summary: This is prospective, non-randomized, single-arm, international, multicenter, clinical safety and performance clinical investigation to evaluate the AccuCinch® Ventricular Repair System for the treatment of heart failure, with or without functional mitral regurgitation due to dilated ischemic or non-ischemic cardiomyopathy

status: Active, not recruiting

lead_sponsor: Ancora Heart, Inc.

location_country:
Poland
Belarus
United Kingdom
Italy
Lithuania
Switzerland
France
Belgium
Netherlands
Czechia

location_facility: Republican Scientific and Practical Centre of Cardiology

location_facility: Vilnius University Hospital Santaros Klinikos


title: Prospective, Multicenter, Randomized, Controlled Study Evaluating SIR-Spheres Y-90 Resin Microspheres Preceding Cisplatin-gemcitabine (CIS-GEM) Chemotherapy Versus CIS-GEM Chemotherapy Alone as First-line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma

acronym: SIRCCA

summary: The study will evaluate the benefit of applying Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment (cisplatin-gemcitabine, or CIS-GEM) in patients with unresectable intrahepatic cholangiocarcinoma. Half of the patients will be randomized to CIS-GEM chemotherapy plus SIRT, and half of the patients will be randomized to CIS-GEM alone.

lead_sponsor: Sirtex Medical

location_country:
Spain
Italy
United Kingdom
Australia
United States
France
Belgium
Netherlands

location_facility: Hammersmith Hospital Imperial College Healthcare NHS Trust

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust


title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy, Safety and Tolerability of AQW051 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Moderate to Severe L-dopa Induced Dyskinesias

summary: This study will assess the safety, tolerability and efficacy of AQW051 in treating moderate to severe L-dopa induced dyskinesias (movement disorders) in patients with Parkinson's disease.

ReferenceCitation: Trenkwalder C, Berg D, Rascol O, Eggert K, Ceballos-Baumann A, Corvol JC, Storch A, Zhang L, Azulay JP, Broussolle E, Defebvre L, Geny C, Gostkowski M, Stocchi F, Tranchant C, Derkinderen P, Durif F, Espay AJ, Feigin A, Houeto JL, Schwarz J, Di Paolo T, Feuerbach D, Hockey HU, Jaeger J, Jakab A, Johns D, Linazasoro G, Maruff P, Rozenberg I, Sovago J, Weiss M, Gomez-Mancilla B. A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia. Mov Disord. 2016 Jul;31(7):1049-54. doi: 10.1002/mds.26569. Epub 2016 Mar 15.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
United States
Italy
France


title: A Phase 3 Evaluation of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 4

summary: The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).

ReferenceCitation: Hézode C, Alric L, Brown A, Hassanein T, Rizzetto M, Buti M, Bourlière M, Thabut D, Molina E, Rustgi V, Samuel D, McPhee F, Liu Z, Yin PD, Hughes E, Treitel M; COMMAND-4 study team. Randomized controlled trial of the NS5A inhibitor daclatasvir plus pegylated interferon and ribavirin for HCV genotype-4 (COMMAND-4). Antivir Ther. 2015 Aug 27;21(3):195-205. doi: 10.3851/IMP2985. [Epub ahead of print]

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
Greece
United Kingdom
Puerto Rico
United States
France

location_facility:
University Gastroenterology
Scti Research Foundation
Metropolitan Research
Umass Memorial Medical Center
Local Institution


title: A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis

acronym: REFINE

summary: The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting Multiple Sclerosis (RRMS).

lead_sponsor: Biogen

location_country: Spain Italy France Belgium Germany


title: Is the Endoscopic Remission Evaluation, Using the CREDO 1 Index / Score in CD Patients in Clinical Remission at Baseline, Predictive of Sustained Clinical Remission Using a 2-year Follow up: a Multicenter Prospective Cohort Study

summary:
The CREDO 2 study follows CREDO 1 study, which aims to construct an objective evaluation of endoscopic remission in Crohn's Disease (CD). In addition to reproducibility and validation, the predictive value of this remission evaluation needs to be tested in different settings to valorise its usefulness in clinical practice and in clinical trials.

CREDO 2 aims to investigate whether the evaluation of endoscopic remission, as defined in CREDO 1, in patients in clinical remission is predictive of sustained clinical remission at 2 years.

The design of CREDO2 is a multicentre longitudinal prospective cohort study. The screening period to include a patient is two weeks. Patients will be followed up to week 104.

primary_purpose: Other

ipd_sharing_description: ND

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_country: France Belgium

location_facility:
CHU Montpellier - Hôpital Saint Eloi
CHU Estaing - Clermont Ferrand
CHU Besançon - Hôpital Jean Minjoz
CHU de Nice - Hôpital de l'Archet 2
Hôpital Saint Antoine
Leuven University Hospital
CHU Liège
UZ Leuven
APHP- Hopital BEAUJON
CHU Nancy - Hôpital Barbois
AZ Sint Lucas Gent
CHU Bordeaux - Hôpital Haut Lévêque
CHU Nantes - Hôtel Dieu
CHRU de Lille - Hôpital C. Huriez

intervention_type: Diagnostic Test


title: Treat to Target Trial in Axial Spondylo Arthritis : The TICOSPA (Tight Control in Spondyloarthritis)

acronym: TICOSPA

summary: This is a not interventional, pragmatic, prospective, randomized (cluster) study to evaluate the potential benefit of a Treat to Target approach in comparison to routine treatment (i.e. usual care) in patients with axial spondyloarthritis.

ReferenceCitation: Molto A, López-Medina C, Van den Bosch FE, Boonen A, Webers C, Dernis E, van Gaalen FA, Soubrier M, Claudepierre P, Baillet A, Starmans-Kool M, Spoorenberg A, Jacques P, Carron P, Joos R, Lenaerts J, Gossec L, Pouplin S, Ruyssen-Witrand A, Sparsa L, van Tubergen A, van der Heijde D, Dougados M. Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial. Ann Rheum Dis. 2021 Nov;80(11):1436-1444. doi: 10.1136/annrheumdis-2020-219585. Epub 2021 May 6.

lead_sponsor: Association de Recherche Clinique en Rhumatologie

location_country: Netherlands France Belgium

location_facility:
Reumatologie Medizorg
Hopital Lapeyronnie
Chu Grenoble
Jessa Ziekenhuis
Chu Gabriel Montpied
Ch Mulhouse
Hopital Cochin
Hopital Henri Mondor
LUMC
Maastricht UMC
UMCG
Hopital de La Pitie Salpetriere
Chu Rouen
AZ Alma
Chu Toulouse
UZ GENT
Zuyderland MC
Chu Le Mans