title: TIGER-2: A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral CO-1686 as 2nd Line EGFR-directed TKI in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC)

acronym: NSCLC

summary: The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The trial is open-ended, which means patients will continue to take rociletinib until the study doctor determines it is no longer beneficial for them.

status: Terminated

lead_sponsor: Clovis Oncology, Inc.

location_country:
Germany
United Kingdom
Hong Kong
Australia
Netherlands
Switzerland
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Centre Hospitalier Universitaire Hôpital Nord

location_facility: Universitaetsklinikum Bonn - Zentrum fuer Innere Medizin - Medizinische Klinik und Poliklink III

location_facility: University of California Davis Medical Center

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hospitalier Universitaire Vaudoise

location_facility: University of California San Diego Moores Cancer Center

location_facility: Yakima Valley Memorial Hospital, North Star Lodge

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Washington University School of Medicine

location_facility: Guy's and Saint Thomas NHS Foundation Trust

location_facility: Centre Hospitalier Regional Universitaire (CHRU) de Besancon - L'Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire Côte de Nacre

status_simplified: Unknown


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: AbbVie

summary: This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3).

location_facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 227623

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 206209

location_facility: Norton Cancer Institute - St Matthews /ID# 203284

location_facility: Arkhangelsk Clinical Oncology Dispensary /ID# 216418

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 230595

location_facility: St John Of God Subiaco Hospital /ID# 226943

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 205528

location_facility: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti /ID# 227216

location_facility: L'Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità San Giuseppe Mos /ID# 204707

location_facility: St. Petersburg scientific center for specialized medical care (oncological) /ID# 206405

location_facility: St Vincent's University Hospital /ID# 205102

location_facility: Regional Children's Clinical Hospital of Volgograd /ID# 206520

location_facility: Mater Misericordiae Univ Hospital /ID# 231466

location_facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 204878

location_facility: Washington University-School of Medicine /ID# 203217

location_facility: Hirosaki University Hospital /ID# 245023

location_facility: The First People's Hospital of Changzhou /ID# 210787

location_facility: The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 227244

location_facility: Hospital Universitario Vall d'Hebron /ID# 206997

location_facility: Kobe Minimally Invasive Cancer Center /ID# 248590

location_facility: Hospital Universitario Ramon y Cajal /ID# 203922

location_facility: Sutter Medical Center Sacramen /ID# 203299

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 204367

location_facility: CHU Strasbourg - Hopital Civil /ID# 208080

location_facility: VA Caribbean Healthcare System /ID# 206336

location_facility: The University of Chicago Medical Center /ID# 203216

location_facility: Trakya University Medical Facu /ID# 205242

location_facility: LA Hematology-Oncology Med Group /ID# 203338

location_facility: The First Affiliated Hospital of Guangzhou Medical University /ID# 232261

location_facility: IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 227011

location_facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 231948

location_facility: Dana-Farber Cancer Institute /ID# 203248

location_facility: Hospital Universitario Virgen Macarena /ID# 230998

location_facility: KSW Kantonsspital Winterthur /ID# 231284

location_facility: Fujieda Municipal General Hospital /ID# 248589

location_facility: Central Maine Medical Center /ID# 216583

location_facility: Rocky Mountain Cancer Centers /ID# 215789

location_facility: CHU Insular-Materno Infantil /ID# 232362

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 205601

location_facility: St. Vincent Frontier Cancer Center /ID# 203292

location_facility: Evangelisches Krankenhaus Hamm /ID# 208043

location_facility: Gazi University Medical Faculty /ID# 239816

location_facility: Kinki-Chuo Chest Medical Center /ID# 216461

location_facility: CHU UCL Namur - Sainte Elisabeth /ID# 234048

location_facility: National Cancer Center Hospital /ID# 205066

location_facility: National Hospital Organization Shikoku Cancer Center /ID# 232252

location_facility: Fudan University Shanghai Cancer Center /Id# 210084

location_facility: Univ of Colorado Cancer Center /ID# 203212

location_facility: CHU Lille - Hôpital Albert Calmette /ID# 205105

location_facility: The Catholic University of Korea, ST. Vincent's Hospital /ID# 229647

location_facility: Kostroma region oncology center /ID# 231317

location_facility: Pusan National University Yangsan Hospital /ID# 233871

location_facility: Hospital Universitario HM Sanchinarro /ID# 203913

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 211154

location_facility: Hospital Regional Universitario de Malaga /ID# 216081

location_facility: Center of Palliative Medicine De Vita /ID# 212900

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 205243

location_facility: Institutul Oncologic Prof Dr I Chiricuta /ID# 206320

location_facility: Harbin Medical University Cancer Hospital /ID# 231573

location_facility: Medical College of Wisconsin /ID# 210062

location_facility: Goshen Center for Cancer Care /ID# 215584

location_facility: Baylor Scott & White Medical Center- Temple /ID# 216578

location_facility: Republican Clinical Oncology Dispensary /ID# 206463

location_facility: Koo Foundation Sun Yat-Sen Cancer Center /ID# 227336

location_facility: Advanced Cancer Treatment Center /ID# 239565

location_facility: Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 215082

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 229797

location_facility: Joliet Oncology-Hematology Associates, LTD /ID# 203238

location_facility: Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 203301

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 205163

location_facility: UMHAT Dr Georgi Stranski EAD /ID# 232024

location_facility: Univercity Headache Clynic,LTD /ID# 212080

location_facility: Mercy Research Mercy Clinic Oklahoma Communities, Inc. / OKC OK /ID# 230154

location_facility: Universitair Ziekenhuis Antwerpen /ID# 217430

location_facility: Affiliated Hospital of Hebei University /ID# 227262

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 205831

location_facility: National Medical Research Radiological Centre /ID# 231263

location_facility: Clinical Oncology Dispensary of Omsk /ID# 239313

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 205530

location_facility: National Hospital Organization Kyushu Cancer Center /ID# 206061

location_facility: AdventHealth Cancer Institute - Orlando /ID# 239960

location_facility: Taichung Veterans General Hospital /ID# 205308

location_facility: Henry Ford Hospital - West Bloomfield /ID# 203220

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 205890

location_facility: Universitatsklinikum Mannheim /ID# 228798

location_facility: Puerto Rico Hematology Oncolog /ID# 206337

location_facility: Anhui Provincial Cancer Hospital /ID# 239058

location_facility: University of California, Los Angeles /ID# 203219

location_facility: Penn State University and Milton S. Hershey Medical Center /ID# 221844

location_facility: Soroka University Medical Center /ID# 204898

location_facility: Instituto Catalan de Oncologia (ICO) Badalona /ID# 216106

location_facility: Nottingham University Hospitals NHS Trust /ID# 231224

location_facility: Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 215918

location_facility: Beth Israel Deaconess Medical Center /ID# 208124

location_facility: Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej /ID# 231476

location_facility: Gabrail Cancer Center Research /ID# 216056

location_facility: Vanderbilt Ingram Cancer Center /ID# 203281

location_facility: Houston Methodist Hospital - Scurlock Tower /ID# 213268

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio /ID# 231960

location_facility: West China Hospital, Sichuan University /ID# 210022

location_facility: Universitaetsklinikum Giessen /ID# 231856

location_facility: Thompson Cancer Survival Ctr /ID# 228874

location_facility: Fujian Provincial Cancer Hospital /ID# 210808

location_facility: Yamaguchi - Ube Medical Center /ID# 227778

location_facility: Hospital Nuestra Senora de Sonsoles /ID# 232367

location_facility: Krankenhaus Martha-Maria Halle-Doelau /ID# 205442

location_facility: Hospital Universitario y Politecnico La Fe /ID# 203862

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211119

location_facility: Ottawa Hospital Research Institute /ID# 205579

location_facility: Capital Health Medical Center /ID# 203403

location_facility: Torokbalinti Tudogyogyintezet /ID# 204883

location_facility: Northwestern University Feinberg School of Medicine /ID# 203239

location_facility: Azienda Ospedaliero-Universitaria di Parma /ID# 204983

location_facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 232010

location_facility: Princess Margaret Cancer Centre /ID# 204423

location_facility: Aichi Cancer Center Hospital /ID# 207790

location_facility: Chonnam National University Hwasun Hospital /ID# 206951

location_facility: National Taiwan University Hospital /ID# 205100

location_facility: Linkou Chang Gung Memorial Hospital /ID# 205424

location_facility: Hospital Universitario Dexeus - Grupo Quironsalud /ID# 232368

location_facility: Highlands Oncology Group, PA /ID# 215600

location_facility: Osaka International Cancer Institute /ID# 210735

location_facility: Seoul National University Bundang Hospital /ID# 204237

location_facility: Krasnoyarsk Regional Clinical Oncology Dispensary n.a. A.I. Kryzhanovsky /ID# 232065

location_facility: Asklepios Fachkliniken Muenchen-Gauting /ID# 207789

location_facility: Niigata Cancer Center Hospital /ID# 216462

location_facility: Centre Hosp Intercommunal de Creteil /ID# 227108

location_facility: The Cancer Institute Hospital Of JFCR /ID# 216463

location_facility: Adana Sehir Egitim ve Arastirma Hastanesi /ID# 206000

location_facility: Massachusetts General Hospital /ID# 203215

location_facility: Akdeniz Universitesi Tip Fakul /ID# 205238

location_facility: Yokohama Municipal Citizen's Hospital /ID# 248374

location_facility: University College London Hospitals NHS Foundation Trust /ID# 231467

location_facility: Dartmouth-Hitchcock Medical Center /ID# 203350

location_facility: Taipei Medical University Shuang Ho Hospital /ID# 215356

location_facility: Hospital Universitario Fundacion Alcorcon /ID# 232361

location_facility: Hospital Universitario Virgen del Rocio /ID# 216058

location_facility: NorthShore University HealthSystem /ID# 215583

location_facility: Guangxi Medical University Cancer Center /ID# 231560

location_facility: The Chaim Sheba Medical Center /ID# 204254

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 216153

location_facility: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 205309

location_facility: Matsusaka Municipal Hospital /ID# 230219

location_facility: Haematologisch-Onkologische Praxis im Zentrum Augsburg /ID# 232052

location_facility: Duplicate_Veszprem Megyei Tudogyogyintez /ID# 213950

location_facility: Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 228868

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 205423

location_facility: National Cheng Kung University Hospital /ID# 205307

location_facility: Virginia Cancer Specialists - Fairfax /ID# 203224

status: Active, not recruiting

title: Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

study_completion_date_type: Anticipated

location_country:
Germany
Ireland
Poland
Australia
Japan
Turkey
Czechia
Canada
France
Hungary
Switzerland
United States
Romania
Belgium
China
Puerto Rico
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU)

acronym: MERU

summary: This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.

study_completion_date_type: Actual

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Tanaka K, Isse K, Fujihira T, Takenoyama M, Saunders L, Bheddah S, Nakanishi Y, Okamoto I. Prevalence of Delta-like protein 3 expression in patients with small cell lung cancer. Lung Cancer. 2018 Jan;115:116-120. doi: 10.1016/j.lungcan.2017.11.018. Epub 2017 Nov 22.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Finland
Germany
Ireland
Poland
Australia
Brazil
Japan
Turkey
Croatia
Czechia
Canada
Serbia
France
Belarus
Lithuania
Portugal
Hungary
Hong Kong
Denmark
Switzerland
United States
Latvia
Ukraine
Belgium
China
Estonia
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159160

location_facility: Unidade Local Saude Matosinhos /ID# 159950

location_facility: China Medical University Hosp /ID# 158981

location_facility: Ashland-Bellefonte Cancer Ctr /ID# 202901

location_facility: 4th Military Medical Universit /ID# 203986

location_facility: Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 159013

location_facility: UMHAT Tsaritsa Joanna - ISUL /ID# 159638

location_facility: Hospital Teresa Herrera - CHUAC /ID# 164368

location_facility: Fujian Provincial Cancer Hospital /ID# 204864

location_facility: Taichung Veterans General Hosp /ID# 159047

location_facility: First Affiliated Hospital of Xi'an Jiaotong University /ID# 203733

location_facility: Hospital Universitario La Paz /ID# 159692

location_facility: British Columbia Cancer Agency /ID# 163721

location_facility: Centro de Investigación Clinica Chapultepec /ID# 160965

location_facility: Cancer Specialists of North Florida - Southpoint /ID# 156595

location_facility: Dr Albert, Bouwer and Jordaan Incorporated /ID# 158873

location_facility: CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159131

location_facility: Tennessee Oncology-Nashville Centennial /ID# 161168

location_facility: Christie NHS Foundation Trust /ID# 159037

location_facility: Hospital Clinico Universitario San Carlos /ID# 159706

location_facility: Klaipeda University Hospital /ID# 160018

location_facility: Odense Universitets Hospital /ID# 158054

location_facility: Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 158783

location_facility: VA Pittsburgh HealthcareSystem /ID# 159284

location_facility: Hospital Evangelico de Cachoei /ID# 159657

location_facility: Akershus universitetssykehus /ID# 201682

location_facility: OOO Centre of Palliative Medicine De Vita /ID# 206855

location_facility: Liga Norte Rio Grandense Cont. /ID# 159011

location_facility: Krankenhaus Nord - Klinik Floridsdorf /ID# 201768

location_facility: Dalin Tzu Chi General Hospital /ID# 158983

location_facility: Municipal institution Multifie /ID# 159130

location_facility: National Medical Research Cntr /ID# 169885

location_facility: Korea University Guro Hospital /ID# 159302

location_facility: Icahn School of Med Mt. Sinai /ID# 159210

location_facility: Windsor Regional Cancer Centre /ID# 170869

location_facility: Kaluga Regional Clinical Oncol /ID# 160180

location_facility: N.N. Petrov Research Inst Onc /ID# 159370

location_facility: Hospital Universitario Vall d'Hebron /ID# 159708

location_facility: Gabrail Cancer Center Research /ID# 156667

location_facility: SMZ Baumgartner Höhe, Otto-Wagner-Spital und Pflegezentrum /ID# 201776

location_facility: Hopitaux Universitaires de Geneve /ID# 160603

location_facility: Tri-Service General Hospital /ID# 158980

location_facility: Cancercare Langenhoven Drive Oncology Centre /ID# 159126

location_facility: Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159661

location_facility: National Hospital Organization Himeji Medical Center /ID# 165899

location_facility: Kanagawa Cardiovascular and Respiratory Center /ID# 165015

location_facility: Aichi Cancer Center Hospital /ID# 164976

location_facility: University Hospital Limerick /ID# 159714

location_facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 158962

location_facility: The Affiliated Cancer Hospital of Xinjiang Medical university /ID# 203641

location_facility: Ordensklinikum Linz GmbH, Elisabethinen /ID# 159564

location_facility: Institut za onkologiju i radio /ID# 160904

location_facility: PE PMC Acinus, Medical and Diagnostic Center /ID# 165543

location_facility: Calvary North Adelaide Hospita /ID# 161701

location_facility: Thompson Cancer Survival Ctr /ID# 202460

location_facility: Southeastern Regional Medical /ID# 163064

location_facility: Ege University Medical Faculty /ID# 159243

location_facility: Northwell Health - Monter Cancer Center /ID# 159252

location_facility: General Oncological Hospital /ID# 159159

location_facility: Asklepios Fachkliniken M. Gaut /ID# 158789

location_facility: Christiana Care Health Service /ID# 159212

location_facility: Szpitale Pomorskie Sp. z o.o /ID# 159605

location_facility: Hacettepe University Medical Faculty /ID# 159242

location_facility: National Cancer Center Hospital East /ID# 165721

location_facility: Klinika za plucne bolesti Jordanovac /ID# 159505

location_facility: Erciyes University Medical Fac /ID# 202269

location_facility: Orszagos Koranyi Pulmonologiai Intezet /ID# 158953

location_facility: Duke University Medical Center /ID# 156706

location_facility: East Tallinn Central Hospital /ID# 160019

location_facility: Policlinico Universitario Campus Bio-Medico /ID# 160874

location_facility: Sparrow Regional Cancer Center, Sparrow Health System /ID# 156590

location_facility: Nebraska Hematology Oncology /ID# 156534

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 159709

location_facility: Stavanger Universitetssykehus /ID# 159575

location_facility: Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 159604

location_facility: Akdeniz Universitesi Tip Fakul /ID# 160791

location_facility: Queen Elizabeth Medical Centre /ID# 162899

location_facility: Health Pharma professional Ser /ID# 160734

location_facility: Arkhangelsk clinical oncology /ID# 159367

location_facility: Soroka University Medical Center /ID# 159762

location_facility: Thoraxklinik Heidelberg gGmbH /ID# 158871

location_facility: National Cancer Center Hospital /ID# 166547

location_facility: University of Florida - Archer /ID# 155799

location_facility: Kanazawa University Hospital /ID# 165127

location_facility: Palo Alto Veterans Institute for Research /ID# 203695

location_facility: Tel Aviv Sourasky Medical Center /ID# 161467

location_facility: St Jude Hospital dba St Joseph /ID# 156526

location_facility: Bobruysk Interdistrict Onco. /ID# 169393

location_facility: The Royal Bournemouth Hospital /ID# 159039

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159012

location_facility: North Estonian Medical Centre /ID# 159779

location_facility: National Cheng Kung University Hospital /ID# 158799

location_facility: CHA Bundang Medical center CHA University /ID# 161281

location_facility: Houston Methodist Hospital - Scurlock Tower /ID# 202323

location_facility: Sarah Cannon Research Institute-Chattanooga /ID# 202933

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 158798

location_facility: Mogilev Reg Clin Oncology Dis /ID# 159384

location_facility: Nemocnice Rudolfa a Stefanie /ID# 159655

location_facility: Assaf Harofeh Medical Center /ID# 201883

location_facility: St. Luke's Mountain States Tumor Institute - Boise /ID# 156691

location_facility: Kyungpook National University Chilgok Hospital /ID# 159301

location_facility: Salzburger Landeskliniken (SALK) /ID# 201779

location_facility: Smolensk Regional Onc Clin Dis /ID# 159372

location_facility: Metropolitan General Hospital /ID# 202422

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 160903

location_facility: Torbay Hospital - So Devon HC /ID# 159041

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 159044

location_facility: University Hospital Waterford /ID# 159713

location_facility: Evangelische Lungenklinik Berl /ID# 158935

location_facility: Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159658

location_facility: Klinicki bolnicki centar Sestre milosrdnice /ID# 159090

location_facility: AUSL 8 Arezzo Ospedale San Don /ID# 160897

location_facility: St Vincent's University Hosp /ID# 161678

location_facility: Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159865

location_facility: State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159383

location_facility: Yokohama City University Hospital /ID# 165746

location_facility: Japanese Red Cross Okayama Hospital /ID# 165157

location_facility: Centro Hospitalar Lisboa Norte, EPE /ID# 159957

location_facility: Taipei Veterans General Hosp /ID# 203699

location_facility: Bezmi alem Vakif Universitesi /ID# 202267

location_facility: R.S. McLaughlin Durham Regional /ID# 170870

location_facility: IFO Istituto Nazionale Tumori /ID# 158912

location_facility: Affinity Clinical Research Ser /ID# 158887

location_facility: Klinicki bolnicki centar Rijeka /ID# 159504

location_facility: University Hospital of Ioannin /ID# 159158

location_facility: Stony Brook University Hospital /ID# 159272

location_facility: Tokushima University Hospital /ID# 166105

location_facility: Istanbul Medeniyet Universites /ID# 200126

location_facility: Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 159864

location_facility: Cancercare Outeniqua Oncology Unit /ID# 200689

location_facility: Centre Hosp Intercommunal de Creteil /ID# 162686

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 160016

location_facility: Wojewodzki Szpital Specjalisty /ID# 159603

location_facility: Chungbuk National University /ID# 159300

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 202409

location_facility: Maastricht Universitair Medisch Centrum /ID# 161669

location_facility: IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 160898

location_facility: MD Anderson Cancer Center at Cooper - Camden /ID# 156681

location_facility: Haukeland University Hospital /ID# 159573

location_facility: Centro Hospitalar do Porto EPE /ID# 203582

location_facility: Ospedale Santa Maria delle Cro /ID# 158911

location_facility: Institute For Pulmonary Diseas /ID# 164250

location_facility: University Hospital Linkoping /ID# 159046

location_facility: Hospital Parc de Salut del Mar /ID# 159690

location_facility: Univ Medical Ctr Brackenridge /ID# 155798

location_facility: UT Southwestern Medical Center /ID# 157848

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159659

location_facility: West Virginia Univ School Med /ID# 156687

location_facility: Csongrad Megyei Mellkasi Beteg /ID# 158952

location_facility: Volyn Regional Medical Oncology Centre /ID# 159133

location_facility: Harbin Medical University Cancer Hospital /Id# 203638

location_facility: Goshen Center for Cancer Care /ID# 156682

location_facility: Kansai Medical University Hospital /ID# 165054

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz - Pulmonologia /ID# 202466

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 159693

location_facility: Universitair Medisch Centrum Utrecht /ID# 158083

location_facility: Riga East Clinical University /ID# 158716

location_facility: NorthShore University HealthSystem - Evanston Hospital /ID# 156664

location_facility: Parkland Health and Hosp Syste /ID# 170933


title: Randomized, Controlled, Open-label, Phase 3, Global Multi - Center Trial to Assess the Efficacy and Safety of Zipalertinib Plus Chemotherapy Versus Chemotherapy Alone, in Patients With Previously Untreated, Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations

summary: The purpose of this study is to will evaluate the safety and efficacy of zipalertinib in combination with standard first-line platinum-based chemotherapy compared to chemotherapy alone, in patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations.

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: Taiho Oncology, Inc.

location_country:
Germany
Italy
Poland
Israel
Singapore
United Kingdom
Japan
Netherlands
Belgium
United States
Korea, Republic of
Spain
Turkey
Canada
Philippines
France

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastanesi

location_facility: Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST

location_facility: Azienda Unità Sanitaria Locale della Romagna

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Algemeen Ziekenhuis Delta - Campus Rumbeke

location_facility: Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve Arastirma Hastanesi

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Azienda Ospedaliero - Universitaria di Modena

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: Catholic University of Korea Saint Vincent's Hospital

location_facility: Hospital Regional Universitario de Málaga - Hospital General

location_facility: T.C. Saglik Bakanligi - Istanbul Il Saglik Mudurlugu - Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: T.C. Saglik Bakanligi Ankara Bilkent Sehi?r Hastanesi?

location_facility: William Osler Health System - Brampton Civic Hospital

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Trakya Üniversitesi Sa?l?k Ara?t?rma ve Uygulama Merkezi

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Universitätsklinikum Gießen und Marburg - Gießen

location_facility: Torbay and South Devon NHS Foundation Trust

location_facility: Bagcilar Medipol Mega Universite Hastanesi


title: Global Multicentre Kidney Transplant Advagraf Conversion Registry. A Non-interventional Post-authorisation Study (PAS)

acronym: CHORUS

summary: A study to evaluate changes over time in renal function from baseline (time of conversion) up until five years post conversion in kidney transplant patients converted from tacrolimus twice daily (BD) formulations to a once daily formulation as Advagraf.

status: Completed

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
Germany
Poland
Australia
Japan
Thailand
Vietnam
Czechia
Canada
Serbia
France
Portugal
Hungary
Hong Kong
Romania
Belgium
Malaysia
Philippines
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan

location_facility:
Site KR8206
Site IT3909
Site SB3803
Site FR3312
Site IT3912
Site TW8863
Site AU6111
Site FR3318
Site KR8210
Site JP8105
Site FR3309
Site PT3511
Site JP8107
Site NL3104
Site DE4902
Site GB4401
Site TH6601
Site SB3804
Site KR8216
Site FR3302
Site IT3910
Site IT3911
Site FR3317
Site IT3901
Site KR8202
Site ES3410
Site IT3908
Site HU3602
Site GB4408
Site GB4405
Site DE4903
Site AU6107
Site FR3311
Site AU6108
Site FR3325
Site KR8219
Site TH6603
Site ES3401
Site JP8110
Site TW8862
Site AT4302
Site RO4001
Site AU6110
Site PL4808
Site AT4301
Site KR8201
Site IT3902
Site RO4002
Site HK8201
Site KR8215
Site VN8402
Site KR8209
Site FR3308
Site KR8203
Site NL3103
Site GB4407
Site KR8204
Site FR3303
Site TW8861
Site RO4004
Site FR3305
Site JP8102
Site KR8212
Site NL3105
Site AT4304
Site KR8205
Site IT3915
Site PL4806
Site ES3403
Site KR8208
Site FR3316
Site IT3916
Site GB4402
Site FR3307
Site FR3324
Site VN8401
Site NL3101
Site FR3322
Site JP8109
Site RO4003
Site IT3905
Site JP8106
Site KR8213
Site AU6106
Site IT3914
Site IT39013
Site JP8108
Site JP8104
Site FR3315
Site PL4801
Site FR3319
Site AU6105
Site IT3904
Site JP8101
Site GR3002
Site SB3801
Site IT3903
Site FR3323
Site PL4807
Site AU6104
Site SB3802
Site TH6602
Site CA1001
Site KR8214
Site FR3301
Site FR3306
Site PH6303
Site KR8211
Site FR3321
Site FR3313
Site HU3601
Site JP8111
Site AU6103
Site IT3913
Site IT3906
Site AT4303
Site KR8218
Site IT3907
Site MY6001
Site GR3004
Site FR3310
Site CZ4202
Site DE4901
Site HK8521
Site FR3314
Site GB4403
Site KR8207
Site BE3201
Site GB4406

status_simplified: Completed


type: Registry Identifier

title: A Phase 2, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy

summary: This study enrolled participants with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A participants received BGB-290; in Arm B participants received placebo. The purpose of this study is to show that BGB-290 (pamiparib) (versus placebo) will improve progression-free survival (PFS) in participants with advanced or inoperable gastric cancer.

lead_sponsor: BeiGene

location_country:
Poland
Hungary
Hong Kong
Romania
Australia
Japan
Singapore
United Kingdom
Belgium
United States
China
Spain
Taiwan
Czechia
Georgia
Russian Federation
France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Peterborough And Stamford Hospitals - Haematology & Oncology

location_facility: NHS - Guy's & St Thomas' Hospital - Medical Oncology

location_facility: Guy's and St Thomas NHS Foundation Trust

location_facility: Novant Health & Presbyterian Healthcare - Presbyterian Hospi

location_facility: LTD Acad.F.Todua Medical Center -Research Institute of Clinical Medicine

location_facility: Hyogo College of Medicine College Hospital

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Northern Jiangsu people's hospital - Oncology

location_facility: Sun Yat-sen University - Cancer Center (SYSUCC)

location_facility: Aichi Cancer Center Hospital - Clinical Oncology

location_facility: AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: The First Affiliated Hospital of Xinxiang Medical University

location_facility: Baptist Health Medical Group Oncology, LLC - Research Center

location_facility: Cancer Hospital of Shantou University Medical College - Oncology

location_facility: Multiprofile Clinic Consilium Medulla LTD

location_facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: National Hospital Organization - Osaka National Hospital

location_facility: Liaoning Cancer Hospital & Institute - Medical Oncology

location_facility: 1st Affiliated Hospital of Nanjing Medical U

location_facility: AZ Maria Middelares - Campus Maria Middelares

location_facility: Scientific Research Center of Oncology LTD

location_facility: Tri-Service General Hospital - Neihu Branch - Hematology

location_facility: The Townsville Hospital and Health Service

location_facility: Ballarat Oncology and Haematology Services

location_facility: Oregon Health and Science University Knight Cancer Institute - Hematology Medical Oncology - Hematology Medical Oncology

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór

location_facility: The Affiliated Hospital Of Qingdao University

location_facility: Osaka University Hospital - Medical Oncology

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi

location_facility: Beijing Cancer Hospital - Digestive Tumor Medical

location_facility: The Second Affiliated Hospital of Zhejiang University

location_facility: Vanderbilt University Medical Center (VUMC)

location_facility: Osaka International Cancer Institute - Medical Oncology

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli

location_facility: Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Japan Community Health Care Organization (JCHO) Kyushu Hospital - Hospital

location_facility: Florida Cancer Specialists - Hematology/Oncology

location_facility: Samara Regional Clinical Oncology Dispensary :

location_facility: GBUZ "Regional clinical oncologic dispensary of Volgograd"

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta

location_facility: Clinical Research Center Sp. z o.o., Medic-R Sp. K.

location_facility: GBOU VPO NorthWestern State Medical University n.a. I.I. Mec

location_facility: Hôpital Privé des Côtes d'Armor - Service oncologie

location_facility: N.N. Petrov Research Institute of Oncology

location_facility: St. Marianna University School of Medicine Hospital

location_facility: The Sixth Affiliated Hospital of Sun Yat-sen University

location_facility: Anhui Medical University - The Second Hospital

location_facility: Harbin Medical University Cancer Hospital - Oncology

location_facility: The first affiliated hospital of Zhengzhou University - Oncology - Oncology

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint

location_facility: Nottingham University Hospitals NHS Trust


summary: This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.

ReferenceCitation: Filho OM, Stover DG, Asad S, Ansell PJ, Watson M, Loibl S, Geyer CE Jr, Bae J, Collier K, Cherian M, O'Shaughnessy J, Untch M, Rugo HS, Huober JB, Golshan M, Sikov WM, von Minckwitz G, Rastogi P, Maag D, Wolmark N, Denkert C, Symmans WF. Association of Immunophenotype With Pathologic Complete Response to Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: A Secondary Analysis of the BrighTNess Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):603-608. doi: 10.1001/jamaoncol.2020.7310.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: Golshan M, Loibl S, Wong SM, Houber JB, O'Shaughnessy J, Rugo HS, Wolmark N, McKee MD, Maag D, Sullivan DM, Metzger-Filho O, Von Minckwitz G, Geyer CE Jr, Sikov WM, Untch M. Breast Conservation After Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: Surgical Results From the BrighTNess Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):e195410. doi: 10.1001/jamasurg.2019.5410. Epub 2020 Mar 18. Erratum In: JAMA Surg. 2021 May 1;156(5):503.

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

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Golshan M, Wong SM, Loibl S, Huober JB, O'Shaughnessy J, Rugo HS, Wolmark N, Ansell P, Maag D, Sullivan DM, Metzger-Filho O, Von Minckwitz G, Geyer CE Jr, Sikov WM, Untch M. Early assessment with magnetic resonance imaging for prediction of pathologic response to neoadjuvant chemotherapy in triple-negative breast cancer: Results from the phase III BrighTNess trial. Eur J Surg Oncol. 2020 Feb;46(2):223-228. doi: 10.1016/j.ejso.2019.10.002. Epub 2019 Oct 5.

ReferenceCitation: Loibl S, O'Shaughnessy J, Untch M, Sikov WM, Rugo HS, McKee MD, Huober J, Golshan M, von Minckwitz G, Maag D, Sullivan D, Wolmark N, McIntyre K, Ponce Lorenzo JJ, Metzger Filho O, Rastogi P, Symmans WF, Liu X, Geyer CE Jr. Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):497-509. doi: 10.1016/S1470-2045(18)30111-6. Epub 2018 Feb 28.

sponsor_collaborators: Grupo Español de Investigación del Cáncer de Mama

location_facility: St. John of God Subiaco Hosp /ID# 120717

location_facility: Community Rgnal Cancer Care N /ID# 120456

location_facility: Hospital Universitario Virgen del Rocio /ID# 135114

location_facility: Wilke/Wagner/Petzoldt, Fuerth /ID# 133481

location_facility: Virginia Oncology Associates /ID# 127260

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 135112

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 122855

location_facility: Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 133472

location_facility: Western Health Sunshine Hosp. /ID# 120715

location_facility: Cedars-Sinai Medical Center - West Hollywood /ID# 137275

location_facility: Misericordia General Hospital /ID# 119536

location_facility: Medical Radiological Res Ctr /ID# 124017

location_facility: Texas Oncology - Medical City Dallas /ID# 126141

location_facility: Solinksy Center for Cancer Care /ID# 131970

location_facility: Univ Hosp Bristol NHS Foundati /ID# 120989

location_facility: Hospital Universitario Arnau de Vilanova de Lleida /ID# 120979

location_facility: Univ Maryland School Medicine /ID# 119235

location_facility: Hospital Universitario Ramon y Cajal /ID# 135113

location_facility: Indiana Univ School Medicine /ID# 118215

location_facility: Stanford University School of Med /ID# 130316

location_facility: University of Illinois - Chicago /ID# 134329

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont /ID# 120834

location_facility: Petz Aladar Megyei Oktato Korh /ID# 120835

location_facility: Rutgers Cancer Institute of NJ /ID# 120477

location_facility: Pyatigorsk Oncology Dispensary /ID# 120945

location_facility: UT Southwestern Medical Center /ID# 133849

location_facility: Cliniques Universitaires Saint Luc /ID# 120719

location_facility: Kursk Regional Oncology Dispen /ID# 116688

location_facility: Kyungpook National University Chilgok Hospital /ID# 118855

location_facility: Hospital Universitario A Coruña - CHUAC /ID# 135108

location_facility: Hospital Clinico Universitario de Valencia /ID# 123076

location_facility: Sanford Roger Maris Cancer Cen /ID# 132394

location_facility: Texas Oncology - Memorial City /ID# 126139

location_facility: Johanniter-Krankenhaus Genthin /ID# 133463

location_facility: Florida Cancer Specialists - Fort Myers /ID# 126379

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 120818

location_facility: Novant Health Oncology Special /ID# 139890

location_facility: Nottingham Univ Hospitals NHS /ID# 122218

location_facility: The Ctr for Cancer and Blood D /ID# 120479

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 116681

location_facility: University Hospitals Case Medical Center /ID# 141691

location_facility: Univ of Wisconsin Hosp/Clinics /ID# 120457

location_facility: Texas Oncology - Medical City Dallas /ID# 126140

location_facility: Florida Cancer Specialists - Fort Myers /ID# 121835

location_facility: Arizona Oncology Associates, PC-HOPE /ID# 126137

location_facility: Horizon Oncology Research Center /ID# 116815

location_facility: Columbia Univ Medical Center /ID# 141588

location_facility: St. John of God Hosp - Murdoch /ID# 131788

location_facility: Seoul National University Hospital /ID# 116698

location_facility: Hosp European, Georges Pompid /ID# 120736

location_facility: Hospital Universitario Miguel Servet /ID# 119195

location_facility: Fundacion Instituto Valenciano Oncologia IVO /ID# 135116

location_facility: Hospital Clinico Universitario San Carlos /ID# 119959

location_facility: Korea University Anam Hospital /ID# 118857

location_facility: Comprehensive Cancer Ctrs Neva /ID# 126136

location_facility: Cleveland Clinic Main Campus /ID# 126378

location_facility: IRCCS Fondazione Salva Maugeri /ID# 120848

location_facility: Istituto Europeo di Oncologia /ID# 120845

location_facility: Miami Cancer Institute - Baptist Health South Florida /ID# 126145

location_facility: Northwestern University Feinberg School of Medicine /ID# 133848

location_facility: Leningrad Reg Onc Dispensery /ID# 120938

location_facility: Hospital Santa Creu i Sant Pau /ID# 145400

location_facility: Minnesota Oncology Hematology, PA /ID# 126144

location_facility: Universitaetsklinikum Schleswig-Holstein /ID# 133454

location_facility: Loyola University Medical Ctr /ID# 120455

location_facility: Vrije Universiteit Medisch Centrum /ID# 126302

location_facility: Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 120944

location_facility: Hospital General Universitario de Valencia /ID# 135111

location_facility: Sunnybrook Health Sciences Ctr /ID# 123312

location_facility: National Institute of Oncology /ID# 120828

location_facility: Studiengesellschaft Onk Bielef /ID# 133471

location_facility: Hospital General Universitario Alicante /ID# 135115

location_facility: Hospital Parc de Salut del Mar /ID# 135110

location_facility: Lehigh Valley Health Network /ID# 133372

location_facility: Oncology Hematology Care, Inc - Blue Ash /ID# 120478

location_facility: Klinikum recht der Isar der TU /ID# 133449

location_facility: OSF St. Anthony Medical Center /ID# 139424

location_facility: Hopital Universitaire Purpan /ID# 120731

location_facility: Christiana Care Health Service /ID# 137823

title: A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer (TNBC)

location_country:
Germany
Italy
Hungary
United Kingdom
Australia
Netherlands
Belgium
United States
Korea, Republic of
Spain
Taiwan
Czechia
Canada
Russian Federation
France


title: A Randomised, Open-label, Phase II, Dose/Schedule Optimisation Study of NUC-3373/Leucovorin/Irinotecan Plus Bevacizumab (NUFIRI-bev) Versus 5-FU/Leucovorin/Irinotecan Plus Bevacizumab (FOLFIRI-bev) for the Treatment of Patients With Previously Treated Unresectable Metastatic Colorectal Cancer

summary:
This is a randomized, open-label, dose/schedule optimization study comparing NUC-3373/leucovorin (LV)/irinotecan plus bevacizumab (NUFIRI-bev) to 5-FU/LV/irinotecan plus bevacizumab (FOLFIRI-bev) for the treatment of patients with unresectable metastatic colorectal cancer.

A total of 171 patients will be randomized 1:1:1 to either NUFIRI-bev on a weekly NUC-3373 schedule, NUFIRI-bev based on an alternate weekly NUC-3373 schedule, or FOLFIRI bev on an alternate weekly schedule. The main objectives are to assess and compare the efficacy and safety of the 3 regimens. Pharmacokinetics will be assessed on the 2 NUFIRI arms.

lead_sponsor: NuCana plc

location_country:
Germany
Italy
United Kingdom
United States
Spain
France

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

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Guy's and Saint Thomas' NHS Foundation Trust

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University of Iowa Hospitals and Clinics

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: University of Florida Health Medical Oncology - Davis Cancer Pavilion

location_facility: Universitätsklinik Ulm - Oberen Eselsberg

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer Center

location_facility: Strasbourg Oncology Liberale - Clinique Sainte-Anne

location_facility: Centre Hospitalier UniversitaireNantes - Hôtel Dieu

location_facility: Ospedale Santa Maria delle Croci di Ravenna

location_facility: Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz

location_facility: Mount Vernon Cancer Centre - East and North Hertfordshire NHS Trust

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS)


title: Transplantation d'Ilots Pancreatiques Allogeniques Adultes Pour le Traitement du Diabete Insulino-dependant: Etude GRAGIL 2.

summary: This research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients with brittle type 1, insulin-dependent diabetes mellitus and to improve their metabolic control.

design_allocation: Non-Randomized

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

oa_host_type: publisher

publisher_dissemination: American Diabetes Association

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Alfediam

location_country: Switzerland France

location_facility: University Hospital, Department of Endocrinology

location_facility: University Hospital, Department of Surgery

intervention_type: Procedure

lead_sponsor_type: academique


acronym: SOPHIA

lead_sponsor: MacroGenics

summary:
The purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy.

A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy.

ReferenceCitation: Rugo HS, Im SA, Cardoso F, Cortes J, Curigliano G, Musolino A, Pegram MD, Bachelot T, Wright GS, Saura C, Escriva-de-Romani S, De Laurentiis M, Schwartz GN, Pluard TJ, Ricci F, Gwin WR 3rd, Levy C, Brown-Glaberman U, Ferrero JM, de Boer M, Kim SB, Petrakova K, Yardley DA, Freedman O, Jakobsen EH, Gal-Yam EN, Yerushalmi R, Fasching PA, Kaufman PA, Ashley EJ, Perez-Olle R, Hong S, Rosales MK, Gradishar WJ; SOPHIA Study Group. Margetuximab Versus Trastuzumab in Patients With Previously Treated HER2-Positive Advanced Breast Cancer (SOPHIA): Final Overall Survival Results From a Randomized Phase 3 Trial. J Clin Oncol. 2023 Jan 10;41(2):198-205. doi: 10.1200/JCO.21.02937. Epub 2022 Nov 4.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

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

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org;sdu.dk

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Rugo HS, Im SA, Cardoso F, Cortes J, Curigliano G, Musolino A, Pegram MD, Wright GS, Saura C, Escriva-de-Romani S, De Laurentiis M, Levy C, Brown-Glaberman U, Ferrero JM, de Boer M, Kim SB, Petrakova K, Yardley DA, Freedman O, Jakobsen EH, Kaufman B, Yerushalmi R, Fasching PA, Nordstrom JL, Bonvini E, Koenig S, Edlich S, Hong S, Rock EP, Gradishar WJ; SOPHIA Study Group. Efficacy of Margetuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):573-584. doi: 10.1001/jamaoncol.2020.7932.

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

repositories_concat: PubMed Central;air.unimi.it;sdu.dk

location_facility: Severance Hospital, Yonsei University Health System

location_facility: The Chaim Sheba Medical Center - Insititute of Oncology

location_facility: Universitaetsklinikum Essen - Klinik fuer Frauenheilkunde

location_facility: H. Santa Maria - Centro Hospitalar Lisboa Norte

location_facility: Fondazione Pascale, IRCCS Istituto Nazionale dei Tumori

location_facility: University of Washington/ Seattle Cancer Care Alliance

location_facility: PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona

location_facility: Saint Barnabas Medical Center - The Cancer Center

location_facility: The Center for Cancer and Blood Disorders

location_facility: University of Texas Southwestern Medical Center

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: Swedish Cancer Institute/ Swedish Health Services

location_facility: Instituto Português Oncologia Francisco Gentil do Porto

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Kaiser Permanente Hawaii Moanalua Medical Center

location_facility: AZ Nikolaas - Campus Sint-Niklaas Moerland

location_facility: AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan

location_facility: ASST Papa Giovanni XXIII - Oncologia-Bergamo

location_facility: Indiana University Health Goshen Center for Cancer Care

location_facility: New York University Clinical Cancer Center

location_facility: Memorial Cancer Institute at Memorial Regional Hospital

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancer

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli

location_facility: Kent Oncology Centre, Maidstone Hospital

location_facility: Hadassah Medical Organisation, Hadassah Medical Center, Ein-Karem

location_facility: Regionshospitalet Herning (Herning Centralsygehus)

location_facility: AO S.Andrea, Università degli Studi di Roma La Sapienza

location_facility: PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco

location_facility: Centro Clínico Champalimaud/Fundação Champalimaud

location_facility: Azienda Ospedaliera Fatebenefratelli e Oftalmico

location_facility: Clalit Health Services - Lin Medical Center

location_facility: South Tees Hospitals NHS Foundation Trust

location_facility: Wake Forest University Baptist Medical Center (WFUBMC)

location_facility: New Jersey Hematology Oncology Associates

location_facility: Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc

location_facility: Azienda Ospedaliero Universitaria Senese Universita degli St

location_facility: CTCA - Southeastern Regional Medical Center

location_facility: CTCA - Eastern Regional Medical Center, Inc.

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: University of California, San Francisco Helen Diller Family Comprehensive Cancer Center

location_facility: Institut Català d'Oncologia-Hospital Germans Trias i Pujol

location_facility: Hospital Universitario Clínico San Carlos

location_facility: Istituto Europeo di Oncologia Via Ripamonti

location_facility: CTCA - Midwestern Regional Medical Center

location_facility: Helsinki University Central Hospital (HUCH) - Meilahden Sair

title: A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment

location_country:
Finland
Germany
Italy
Poland
Portugal
Israel
United Kingdom
Denmark
Netherlands
Austria
Belgium
United States
Korea, Republic of
Spain
Czechia
Canada
Puerto Rico
France


type: Other Identifier

title: Efficacy of a Guiding Device for Inferior Alveolar Nerve Block, EZ-Block®, Compared With a Conventional "Freehand" Administration, in Providing Anesthesia During Surgical Removal of Impacted Lower Third Molar.

summary:
The success rates reported in the literature for the various truncal anesthesia techniques are extremely variable and have shown a lack of reproducibility of the techniques. The use of the EZ-BLOCK® guidance system would increase this success rate in a significant and reproducible way, as it is based on individualized anatomical foundations and therefore adapted to inter-patient variability.

In order to determine its effectiveness in clinical situations encountered in current practice, a comparative clinical study of the 2 techniques (freehand reference technique and using the EZ-BLOCK® system) is necessary.

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Haas DA. Alternative mandibular nerve block techniques: a review of the Gow-Gates and Akinosi-Vazirani closed-mouth mandibular nerve block techniques. J Am Dent Assoc. 2011 Sep;142 Suppl 3:8S-12S. doi: 10.14219/jada.archive.2011.0341.

ReferenceCitation: Ravi Kiran BS, Kashyap VM, Uppada UK, Tiwari P, Mishra A, Sachdeva A. Comparison of Efficacy of Halstead, Vazirani Akinosi and Gow Gates Techniques for Mandibular Anesthesia. J Maxillofac Oral Surg. 2018 Dec;17(4):570-575. doi: 10.1007/s12663-018-1092-5. Epub 2018 Feb 26.

lead_sponsor: Elsan

location_facility: CHRU Nancy Service d'odontologie Brabois adultes

location_facility: Hôpitaux universitaires de Strasbourg Hôpital Civil Pôle de Médecine et chirurgie bucco-dentaires

location_facility: Service de médecine bucco-dentaire Hôpital BRetonneau - APHP

location_facility: Odontologie et traitement dentaire Pôle clinique des voies respiratoires Faculté de chirurgie dentaire


title: Local Ablative Stereotactic Radiotherapy for Residual Hypermetabolic Lesion in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Long-term Responders to Immunotherapy : a Randomized, Multicenter, Open-label Phase III Study

summary:
At present, it is recommended to continue immunotherapy until progression or unacceptable toxicity.

However, only a minority of patients benefits from a durable response and most see the disease progress despite several months of control under immunotherapy. Multimodal approaches have been developed to improve their prognosis.

This study, randomized, open-label study aims to evaluate the impact of addition of ablative radiotherapy on OS of patients with NSCLC and oligometastatic lesions and treated by immunotherapy in first line (potentially associated with chemotherapy) or beyond. Stereotactic radiotherapy will be performed on a maximum of 5 residual hypermetabolic lesions seen on 18F-FDG PET / CT, in patients responding to immunotherapy (or with a stable disease) for at least 6 months.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Centre François BACLESSE
ICO - Site Paul Papin
Institut de cancérologie de l'ouest
Chu de Brest
Chu de Tours

appel_a_projets: PHRCK

region: Pays de la Loire

nom_etablissement: ICO - SITE PAUL PAPIN

type_etablissement: CLCC

titre: Trailoclori01-Radiothérapie stéréotaxique de foyers hypermétaboliques résiduels chez des patients ayant un cancer bronchique non à petites cellules localement avancé ou métastatique et longs répondeurs à une immunothérapie: étude multicentrique en ouvert de phase 3.

discipline_principale: cancer

nom_porteur: HIRET

prenom_porteur: Sandrine


title: Volumétrie Optimisée en Radiologie : intérêt en IRM Cérébrale pédiatrique Dans l'Exploration de l'épilepsie Focale

acronym: ORACLE

summary: Multicentre cross-sectional study with prospective recruitment comparing the detection rate of lesions on brain MRI without and with quantitative volumetry and T1 relaxometry information during the management of children with suspected focal epilepsy.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Tours

location_facility:
Hôpital Clocheville
CHU Grenoble
CHU Montpellier
CHU Rennes
CHU Angers

intervention_type: Other


title: MAster Protocol Studying the Impact of Blood Biopsy on Screening, Diagnosis, Diagnostic and Follow-up of Solid Cancer in Adult

acronym: CIRCAN MAP

summary: This exploratory study will focus on the development of the analyses of blood biomarkers to better understand the circulating biomarkers associated with cancer diagnosis, treatment efficacy and progressive disease

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Pneumologie Aigue Spécialisée et Cancérologie Thoracique Hôpital Lyon-Sud / Groupement Hospitalier Sud

location_facility: Service de dermatologie Hôpital Lyon-Sud / Groupement Hospitalier Sud

location_facility: Service de Pneumologie Hôpital Croix-Rousse / Groupement Hospitalier Nord

location_facility: Service de Pneumologie Hôpital Louis Pradel / Groupement Hospitalier Est

location_facility: Oncologie médicale Hôpital Lyon-Sud / Groupement Hospitalier Sud

intervention_type: Biological


title: Impact d'un Bilan Clinique structuré (MIDSA), de sa Restitution et de l'Accompagnement au Changement Sur l'Engagement Dans le Soin (évalué Par l'échelle URICA) d'Auteurs d'Infraction à caractère Sexuel : Essai contrôlé randomisé Multicentrique en Ouvert

acronym: EV-AICS

summary: Evaluate the effectiveness of an intervention including the clinical assessment carried out with the (Multidimensional Inventory of Development, Sex, and Aggression) MIDSA and the review of the results with the professional in charge of the subject on the adherence and commitment to the care of the sexual offenders.

primary_purpose: Health Services Research

location_facility: CHU Montpellier Lapeyronie - CRIAVS Languedoc-Roussillon

location_facility: CH LE Vinatier - Service de Psychiatrie Légale

location_facility: CHU Poitiers Henri Laborit - CRIAVS - CMP Espace Vienne - SMPR

intervention_type: Behavioral

appel_a_projets: PREPS

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

type_etablissement: CHUR

acronyme: EV-AICS

titre: Impact d'un bilan clinique structuré (MIDSA), de sa restitution et de l'accompagnement au changement sur l'engagement dans le soin (évalué par l'échelle URICA) d'auteurs d'infraction à caractère sexuel : essai contrôlé randomisé multicentrique en ouvert

discipline_principale: psychiatrie / addictologie

nom_porteur: COURTOIS

prenom_porteur: Robert


title: Prospective, Multicentre, Open Study Evaluating the Performance and Stability of the AMIStem-P Femoral Stem

summary: This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis

lead_sponsor: Medacta International SA

location_facility:
Clinique d'Orange
Nouvelle Clinique Bordeaux Tondu
Hôpital Castres
Clinique de Saint Omer
Hôpital Jacques-Puel

intervention_type: Device


title: Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee

acronym: USAK

summary:
Primary objective: Description of ultrasound abnormalities seen in native septic arthritis of the knee during each visit.

Primary endpoint: Describe the ultrasound abnormalities observed on Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee.

lead_sponsor: Poitiers University Hospital

location_facility:
CH De La Rochelle
CH D'Angouleme
CHU de Rennes
CHU de Nantes
CH de La roche-sur-yon


title: Assessment of Tooth Retention 10 Years After Root Canal Treatment With Endomethasone N: a Retro-prospective, National and Multicentre Clinical Study

summary:
The aim of root canal treatment, or endodontic treatment, is to treat pulpal or periapical diseases and thus transform a pathological tooth into a healthy, asymptomatic and functional entity on the dental arch. The diagnosis of pulp pathology is based on the symptomatology described by the patient, on data from the clinical examination and tests performed as well as the radiographic examinations.

Different families of root canal sealers are used in endodontics: cements based on zinc oxide-eugenol (ZOE), resin-based materials, and calcium silicate-based cements. They provide a stable and hermetic sealing. The Septodont laboratory has developed and manufactured endomethasone N, a zinc oxide-eugenol root canal sealer.

The aim of this retro-prospective PMCF study is to collect long term clinical and safety data on root canal obturation after treatment or retreatment by Endomethasone N.

lead_sponsor: Septodont

location_facility:
Private dentist office - Dr JACOB
Private dentist office - Dr PHAM
Private dentist office - Dr LEBRET
Private dentist office - Dr AUBEUX
Private dentist office - Dr ROUBINET


title: Explore the Associations of Behavioral Factors With Treatment Adherence in Axial Spondyloarthritis Patients Treated With Biotherapy

acronym: MAINTAIN II

summary: The management of chronic inflammatory rheumatism, including spondyloarthritis (SpA), has been revolutionized in recent decades with the arrival of biological therapy. The success of the current therapeutic strategy is also based on therapeutic compliance. If therapeutic adherence in rheumatoid arthritis patient (RA) is only 66%, it seems even worse in SpA. Few studies report quantitatively the adherence of SpA patients, as well as the predictive or associated factors. The objective of this study is to assess the patient adherence to biologics in patients with axial SpA (SpAax), and to investigate factors influencing this adherence, in particular the association with vaccination coverage, dietary behavior, and digital health tools.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU Montpellier
Chu Toulouse
CHU Clermont-Ferrand
CHU Bordeaux
CHU Limoges


title: Cross-sectional, Multi-center Study Comparing Diagnostic Performance Between the CAD EYE System and the Physician on Histological Prediction of Colonic Polyps in Screening of Colorectal Cancer by Colonoscopy

acronym: IA COLO

summary: Artificial Intelligence (AI) to predict the histology of polyps per colonoscopy, offers a promising solution to reduce variation in colonoscopy performance. This new and innovative non-invasive technology will improve the quality of screening colonoscopies, and reduce the costs of colorectal cancer screening. The aim of the study is to performed a cross-sectional, multi-center study evaluating the diagnostic performance of the CAD EYE automatic characterization system for the histology of colonic polyps in colorectal cancer screening colonoscopy.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Integrative Analysis of the Tumor Microenvironment and Optimization of the Immunotherapy Duration in Non-small Cell Lung Cancer Patients. OPTIMUNE-LUNG Study

acronym: OPTIMUNE-LUNG

summary: Non-comparative multicentric randomized study to assess long-term benefit of PD-1 inhibition in NSCLC patients who experienced a response between 6 and 12 months after initiation of ICI (immune checkpoint inhibitor PD1/PDL-1 blockade therapy)

lead_sponsor: Institut Bergonié

location_facility:
Centre Hospitalier de la Côte Basque
Institut Bergonie
Clinique Marzet
Clinique Tivoli Ducos
Polyclinique Bordeaux Nord Aquitaine


title: Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc: a Prospective, Multicentric, Randomized, Controlled, Double-blind Study

acronym: GRADE

summary:
The study consists in evaluating the analgesic efficacy of Gabapentin versus Placebo in the short term (72h) acute lumbosacral radiculalgia due to disc herniation.

In addition to the usual analgesic treatment, the patient will receive gabapentin or placebo.

During the three days of treatment, an evaluation of the pain and the tolerance will be performed within the two groups: experimental and control.

lead_sponsor: Lille Catholic University

location_facility:
CH Dunkerque-rheumatology
CH Arras-rheumatology
CHU Rouen-rheumatology
CH Béthune-rheumatology
CHU Caen-rheumatology


title: Evaluation of Gingival Displacement With RACESTYPTINE Solution and RACEGEL: a Prospective, Comparative Randomized Clinical Trial.

acronym: RETRACT

summary:
The study design is a prospective, multi-center randomized, controlled, open label, 3-arm parallel group, post market clinical follow-up (PMCF) Clinical Trial.

The aim of the study is to collect clinical performance and safety data from RACEGEL and RACESTYPTINE Solution. Three gingival retraction techniques are being studied: RACESTYPTINE Solution with cord, RACEGEL with cord and RACEGEL without cord.

The study will demonstrate the expected performance of these 3 techniques in terms of sulcus opening, i.e. a lateral gingival displacement of at least 200 µm (state of the art) allowing the realization of pre-prosthetic impression with subgingivally margins. 90 subjects (teeth) requiring a dental restoration with subgingival margins for placement of a fixed prosthesis will be enrolled in 3 groups (30 in each group). For each participant, two dental impressions are performed: one impression before the gingival retraction and one impression immediately after the gingival retraction. Both impressions are scanned with 3D dental scanner and images are superimposed before analysis of tissue displacement.

collaborators:
Slb Pharma
Rennes University Hospital

sponsor_collaborators:
Septodont
Slb Pharma
Rennes University Hospital

location_facility:
Cabinet dentaire Dr Rubin
Cabinet dentaire
Cabinet dentaire - Médipole 35
Cabinet dentaire Magister


title: ETADAPT- Evaluation of the Impact of Patient's Therapeutic Education (PTE) in Adapted Physical Activity (APA) and Dietetic on the Reproducibility of Radiotherapy Sessions for Prostate Cancers.

acronym: ETADAPT

summary:
The primary objective of this study is to evaluate the impact of Patient's Therapeutic Education (PTE) in Adapted Physical Activity (APA) ans dietetic on the reduction of interventions number on rectal volume (laxative or probe).

The secondary objectives are to evaluate the contribution of Patient's Therapeutic Education (PTE) between the 2 arms on repositionnind during the radiotherapy session, the gastrointestinal toxicity, the need to use laxative or transit regulating treatment or techniques, the quality of life, the undernutrition and food intake, the evolution in eating/hydratation and physical habits.

For the experimetal arm, the satisfaction and the compliance with PTE program will be evaluated, as well as the need of additionnal use of dietary and APA consultations.

lead_sponsor: Centre Leon Berard

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau

location_facility: Groupe Hospitalier Mutualiste de Grenoble Institut Daniel HOLLARD

appel_a_projets: PHRIP

region: Auvergne-Rhône-Alpes

nom_etablissement: CENTRE LEON BERARD

acronyme: ETADAPT

titre: Evaluation de l'effet d'une éducation thérapeutique en activité physique adaptée et en diététique sur la reproductibilité des séances des radiothérapies pour les cancers de la prostate.

discipline_principale: radiothérapie

nom_porteur: ROUX

prenom_porteur: Pascale


title: Descriptive Factors of Intimate Partner Violence on Women Related to "Incapacité Totale de Travail" : Multicenter Prospective Study

acronym: SWIFT

summary:
Intimate partner violence is a real public health problem, and affects all socio-cultural backgrounds It is defined by behavior within an intimate relationship that causes physical, psychological or sexual harm or suffering to the people in that relationship.

Several risk factors exist such as young age, low level of education, exposing to violence during childhood, pregnancy or addictions.

ReferenceCitation: Leppakoski T, Paavilainen E, Astedt-Kurki P. Experiences of emergency care by the women exposed to acute physical intimate partner violence from the Finnish perspective. Int Emerg Nurs. 2011 Jan;19(1):27-36. doi: 10.1016/j.ienj.2010.02.006. Epub 2010 May 20.

ReferenceCitation: Saberi E, Eather N, Pascoe S, McFadzean ML, Doran F, Hutchinson M. Ready, willing and able? A survey of clinicians' perceptions about domestic violence screening in a regional hospital emergency department. Australas Emerg Nurs J. 2017 May;20(2):82-86. doi: 10.1016/j.aenj.2017.02.001. Epub 2017 Mar 6.

ReferenceCitation: Lopez-Ossorio JJ, Gonzalez Alvarez JL, Buquerin Pascual S, Garcia LF, Buela-Casal G. Risk factors related to intimate partner violence police recidivism in Spain. Int J Clin Health Psychol. 2017 May-Aug;17(2):107-119. doi: 10.1016/j.ijchp.2016.12.001. Epub 2017 Jan 31.

ReferenceCitation: Lyons VH, Kernic MA, Rowhani-Rahbar A, Holt VL, Carone M. Use of multiple failure models in injury epidemiology: a case study of arrest and intimate partner violence recidivism in Seattle, WA. Inj Epidemiol. 2019 Aug 12;6:36. doi: 10.1186/s40621-019-0215-x. eCollection 2019.

ReferenceCitation: Choi AW, Lo BC, Wong JY, Lo RT, Chau PC, Wong JK, Lau CL, Kam CW. Clinical Features of Heterosexual Intimate Partner Violence Victims With Escalating Injury Severity. J Interpers Violence. 2021 Sep;36(17-18):8585-8605. doi: 10.1177/0886260519850539. Epub 2019 May 29.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility: Centre Hospitalier Régional d'Orléans (UMJ)


title: Awakening of the Control of the Ankle Dorsiflexors in the Post Stroke Hemiplegic Subject to Improve Walking Activity and Social Participation: Experimental Interventional Study

acronym: WAKE

summary: This study is a multi-center, interventional, experimental, prospective, controlled and randomized study. We propose a reeducation protocol based on an early over-solicitation of the ankle dorsiflexor muscles to promote their "awakening", limit the loss of strength associated with the functional loss and thus allow to reach a more effective walking activity. This should encourage social participation following discharge from the hospital. The main objective is to evaluate the impact of this 6 weeks program on walking speed.

ReferenceCitation: Ferry B, Compagnat M, Yonneau J, Bensoussan L, Moucheboeuf G, Muller F, Laborde B, Jossart A, David R, Magne J, Marais L, Daviet JC. Awakening the control of the ankle dorsiflexors in the post-stroke hemiplegic subject to improve walking activity and social participation: the WAKE (Walking Ankle isoKinetic Exercise) randomised, controlled trial. Trials. 2022 Aug 16;23(1):661. doi: 10.1186/s13063-022-06545-w.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

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

repository_normalized: HAL

repositories:
HAL
PubMed Central
oskar-bordeaux.fr

repositories_concat: HAL;PubMed Central;oskar-bordeaux.fr

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: University Hospital, Limoges

location_facility: University Institute of Rehabilitation Valmante Sud

appel_a_projets: PHRCI

region: Nouvelle-Aquitaine

nom_etablissement: CHU  DE  LIMOGES

type_etablissement: CH

acronyme: WAKE

titre: Réveil de la commande des releveurs du pied chez le sujet hémiplégique post AVC pour améliorer la capacité de marche et la participation sociale : étude interventionnelle expérimentale WAKE (Walking Ankle isoKinetic Exercise)

discipline_principale: avc, rééducation

nom_porteur: DAVIET

prenom_porteur: Jean-Christophe


title: Multicentre Observational Study Evaluating the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy, in Real Life Setting.

acronym: MESOIMMUNE

summary: The objective of this multicentre descriptive analysis is to describe the clinical and biological characteristics of patients who have received Programmed cell death 1 (anti-PD1) / (PDL1) Programmed death-ligand 1 (PDL1) immunotherapy outside of a clinical trial in terms of efficacy and safety.

time_perspective: Other

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
CHI Créteil
CH Côte basque
CHU Brest
CHU Lille
CH Cherbourg


title: Left Ventricular Assist Device (LVAD) Versus Guideline Recommended Medical Therapy in Ambulatory Advanced Heart Failure Patients (GDMT)

acronym: AMBU-VAD

summary:
Heart failure is a severe disease affecting approximately 1-2% of the adult population in developed countries and around 26 million people worldwide. Up to 10% of these patients are in advanced stage heart failure, which is defined by a significant morbimortality and considerable medical expenses. Despite advances in its medical management, advanced (or end stage) heart failure is characterized by refractoriness to conventional therapies including guideline-directed pharmacological and non-surgical device treatments. These patients remain severely symptomatic (NYHA IV) and have objective signs of congestion or low cardiac output.

Left ventricular assist devices (LVADs) have been used in patients with heart failure with reduced ejection fraction for almost 20 years either as an alternative or a bridge to heart transplantation. LVADs improve heart failure symptoms and survival at the cost of increased rates of infection, stroke and bleeding.

Despite the lack of evidence, LVAD implantation in ambulatory patients is not rare, with INTERMACS profiles ≥4 patients representing 15.7% of the overall population implanted between 2012 and 2016.

The aim of this study is to investigate the efficacy and safety of left ventricular assist devices compared to traditional HF medical treatment alone in a population of ambulatory advanced heart failure patients. Secondary objectives are to better identify subgroups of patients that would benefit the most from the implantation of an LVAD as well as to assess the optimal timing of intervention.

location_facility: Hôpital Pneumologique et Cardiovasculaire Louis Pradel

location_facility: CHRU, Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu

location_facility: Arnaud de Villeneuve Hospital / CHU Montpellier

appel_a_projets: PHRCN

nom_etablissement: HOSPICES CIVILS DE LYON

acronyme: AMBU-VAD

titre: Assistance ventriculaire gauche versus traitement médical recommandé chez les patients ambulatoires en insuffisance cardiaque avancée

discipline_principale: cardiologie

nom_porteur: BAUDRY

prenom_porteur: Guillaume


title: Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination With Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy: a Randomized Phase II Study

acronym: RoboCUP

summary: We are proposing a randomized phase II study to assess the benefit of bilateral robot-assisted or laser basal tongue mucosectomy in combination with tonsillectomy in the assessment of prevalent cervical lymphadenopathy

lead_sponsor: Centre Francois Baclesse

location_facility:
CHU CAEN
CHU Rouen
Centre Oscar Lambret
Chru Lille
Centre François Baclesse

region: Normandie

nom_etablissement: CRLCC FRANCOIS BACLESSE - CAEN

acronyme: RoboCUP

titre: Intérêt de la mucosectomie de base de langue assistée par robot ou laser en association à l'amygdalectomie homolatérale dans le bilan des adénopathies prévalentes cervicales : étude de phase II randomisée

discipline_principale: soins premiers  , cancer , adénopathies cervicales prévalentes , mucosectomie robot-assisté ou laser , diagnostic , détection d'un cancer primitif , phase ii randomisée

nom_porteur: BASTIT

prenom_porteur: Vianney


title: Impact of an Artificial Intelligence Platform on Inappropriate Medication Use in Older Adults

acronym: PING

summary: Polypharmacy in the older adults is common and promotes the risk of drug interactions. The hypothesis evoked is that a virtual platform with artificial intelligence applied to the health, and in particular to the good use of the drug, could bring aids to the doctors them of the prescription of drugs. The main objective of this study is to evaluate the impact of geriatric use of the Synapse platform on the frequency of inappropriate medication prescriptions (STOPP criteria) in discharge orders for patients 65 years of age or older hospitalized in geriatric department.

location_facility: Centre Hospitalier de Libourne - Pôle Gériatrie


title: DECLIC Patient Education Program : Assessment Through a Population Health Intervention Research Approach (LE DECLIC EPRI)

summary: Cancer pain is a frequent symptom, reported by 20 to 70% of patients in any stage of the cancer disease : 60 to 70% in the advanced stage of the disease and 20 to 40% among the survivors. Among patients who report pain, 40% report undertreated pain. Strengthening Pain management in cancer is a specific objective of the French Cancer Plan. Providing patient education for cancer pain management is recommended since small to moderate efficacy of patient education on pain intensity and interference was found in all meta-analysis. An effect size comparable with some analgesic agents. However, recommendations suggest improvement in order to increase effectiveness and population reach of those interventions. The DECLIC EPRI intervention aim at addressing all the issues raised by patient education for cancer pain management. It was developed according to the framework of Michie's Behavior change wheel theory.

lead_sponsor: Institut Curie

location_facility: GH Diaconesses Croix Saint Simon (GHDCSS)

location_facility: Institut de Cancérologie de l'Ouest Paul Papin


title: Comparison of Intraosseous Anesthesia Osteocentral With Electronic Assistance to Injection to a Conventional Anaesthesia by Infiltration on Temporary Molars

acronym: SLEEPER-ONE

summary:
Anesthesia systems with electronic injection assistance for slow injection pressure-limiting drips (especially for intraosseous anaesthesia) are offered to limit pain. The European Academy of Pediatric Dentistry (EAPD) recommends them for their pen-like appearance which avoids the negative aspect of the classic syringe (Kühnisch 2017). A review systematic review of the literature (Smolarek et al 2019) including 20 randomized controlled trials conducted at children and adolescents showed a significant reduction in pain with the systems with electronic assistance compared to conventional anaesthesia performed with a syringe (-0.8: IC95% (-1.3, -0.3)). Only four of them (Tahmassebi et al 2009, Kandiah and Tahmassebi 2012, Patini et al 2018, Smail-Faugeron et al 2019) were at low risk of bias, and only two parallel group trials were of poor quality and included only children in temporary dentition in which anaesthesia, often problematic, was performed only in the maxilla (Allen et al 2002, Klein et al, 2005) without assessing the intensity of the pain felt.

(FPS-R).

The tested strategy, anesthesia system with electronic injection assistance (SleeperOne® 5 Dental Hi Tec), compared to a conventional metallic anaesthetic syringe currently considered as the standard for performing local anesthesia during oral treatments painful, meets the ISO 13485: 2016 standard.

Elements justifying that the particular surveillance modalities added by research do not involve negligible risks and constraints

Specific monitoring modalities added by research include :

Explanation of the study to each eligible child and his or her legal guardians
Gathering the informed consent of the child and his or her legal guardians
The determination of comparative anesthesia systems (SleeperOne® 5 versus syringe metal)
Data collection during the two care sessions (maximum 15 days apart)

It is a use of a product placed on the market whose conditions of use are in conformity with its destination and its current conditions of use (RIPH Category 2 application decree) There is no additional consultation or visit, nor any additional examination, in relation to the management in accordance with the recommendations of good practice of a child affected by a carious disease corresponding to the children included. On the other hand, the consultation will take a little longer due to the indicators to be collected and the data entry. These particular surveillance modalities added by research have only negligible constraints.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Nantes University Hospital
Lille University Hospital
Rennes University Hospital
Nice Hospital
Toulouse university Hospital


title: Efficiency of Prevention Program Dedicated to Addictive Behaviors (PREVENTURE) of Vulnerable Teenagers

acronym: PREVADO

summary:
At the age of 17, in Brittany, 94.9% of adolescents have experimented alcohol consumption 78.1% within a month and 25.5% report repeated episodes of Intensive Punctual Alcohol. Among the potential explanatory factors of this worrying epidemiology, social and cultural factors induce a social valuation of alcohol consumption and drunkenness. There are also individual vulnerability factors, particularly important in adolescence between experimentation and the transition to regular use or even to alcohol use disorders. Despite the extent of the damage, there is currently little reliable data on effective primary prevention strategies for dealing with addictive behavior. Many prevention programs target age range in school settings, to delay or reduce use of psychoactive substances.

A meta-analysis on the impact of this prevention programs in school settings, concluded that most interventions are associated with no or little impact with respect to the goal of reducing psychoactive substances with teenagers.

Among existing programs, "PREVENTURE" has been evaluated in 5 trials with high-risk teenagers identified in schools settings, in different countries (Canada, Europe). The results show a clear and robust effect on reducing alcohol consumption. This program has not been tested outside the school setting and a recent review mention the need to make this program more accessible by targeting vulnerable groups and studying the impact of this program on this population.

The PREVADO study is a prospective, controlled, randomised, open-label study. After inclusion, the adolescent completes the questionnaire SURPS (Substance Use Risk Profile Scale).

The SURPS is self-report questionnaire that assesses four well-validated personality risk factors for substance misuse (Impulsivity, Sensation Seeking, Anxiety Sensitivity, and Hopelessness). There is a 23-item to which adolescents are asked to respond using a 4-point Likert scale ranging from "strongly agree" to "strongly disagree" : Hopelessness (7 items), Anxiety Sensitivity (5 items), Impulsivity (5 items), and Sensation Seeking (6 items).

Adolescents will be randomized into 2 groups (stratification on the 4 predominant risk personality types from the SURPS (Substance Use Risk Profile Scale) and on the recruitment modality) :

Intervention group : teenagers follow the "PREVENTURE" program and routine cares
Control group : teenagers follow routine cares

ReferenceCitation: Guillou-Landreat M, Tahmazov E, Benoit S, Grall-Bronnec M, Conrod P, Livet A, Nowak E, Le Reste J-. The efficacy of a targeted PREVENTION programme for addictive behaviour (PREVENTURE) among vulnerable ADOlescents in France - study procotol. BMC Public Health. 2021 Apr 23;21(1):783. doi: 10.1186/s12889-021-10795-9.

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

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

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
Catherine SIMON
Morgane GUILLOU - LANDREAT
Loik JOUSNI
Pascale ROZEC
Benoit SCHRECK

region: Bretagne

nom_etablissement: CHRU BREST

acronyme: PREVADO

titre: Efficacité d'un programme de PREVention ciblé des conduites addictives (PREVENTURE) chez des ADOlescents vulnérables

discipline_principale: pédopsychiatrie / addictologie

nom_porteur: GUILLOU LANDREAT

prenom_porteur: MORGANE


title: A Phase II Trial Evaluating Conformational Intensity Modulated Radiotherapy With Concomitant Nivolumab Followed by Nivolumab for Patients With Locally Advanced Non-small Cell Lung Cancer

acronym: AIRING

summary:
Radiotherapy (RT), at a total dose of 60-66 Gy over 6 weeks, combined with platinum-based chemotherapy, is the standard of care for stage III Non-Small Cell Lung Cancers (NSCLC) patients with unresectable or inoperable disease. However, the long-term outcomes are poor, with a 5-year overall survival (OS) rate of 15-35% for stage IIIA, and 5-10% for stage IIIB patients. The recent association of immunotherapy has been proven to improve Progression Free Survival (PFS) and OS for these patients and durvalumab consolidation following chemoradiotherapy (CT-RT) is now the new standard of care.

Compared to older technics (2Dimensions(D) and 3D-RT), intensity-modulated radiotherapy (IMRT) allows for improved organs-at-risk sparing, owing to the high dose conformation to the target volume, thus reducing toxicity rates.

In regard to the recent results of adjuvant immunotherapy, the benefits of concomitant chemotherapy with radiotherapy could be re-evaluated. With the changing landscape in the standard treatment of Local Advanced NSCLC (LA-NSCLC), the reduction in treatment-induced toxicity, while maintaining optimal tumor control, has become a priority, thereby warranting access to adjuvant immunotherapy for these patients. Due to the toxicity of the chemoradiotherapy, a large subset of patients may be unfit for the adjuvant immunotherapy. The use of immunotherapy concomitant to radiotherapy without chemotherapy may be the next step. Nevertheless, as immune cells are highly sensitive to conventional RT doses, the paradigm of the standard irradiation volumes should be reconsidered. In this context, the introduction of IMRT to spare lymphatic tissues and bone marrow deserves evaluation in prospective trials.

A strong body of evidence supports the combination of RT with immunotherapy such as a Programmed cells Death-1 (PD1) inhibitor. Radiation alone can modify the immune response in several ways to allow for synergistic effects when combined with immunotherapy.

The reduction in treatment-induced toxicity while maintaining optimal tumor control has become a priority, thereby warranting access to adjuvant immunotherapy for these patients. In this context, the introduction of IMRT to spare lymphatic tissues and bone marrow deserves evaluation in prospective trials.

The timing of administration of immunotherapy seems to be a major point. Previous data in mice showed that an improved survival benefit with concurrent anti-PD-Ligand1 (PD-L1) and RT versus sequential administration. Moreover, for sequential schedule, an improved survival outcome was found for patients receiving first dose of durvalumab within 14 days of last radiotherapy fraction compared to 14 days or greater.

Furthermore, immunotherapy combined with radiotherapy appears to be safe, without increase of the toxicity.

In summary, there is a strong rationale for testing this new paradigm of accelerated IMRT combined with concurrent and maintenance nivolumab for locally advanced non-small lung cancer, due to:

The unmet medical need for new Standard Of Care (SOC) better tolerated and " as " or " more " effective treatment than CT-RT
The need to decrease radiation-induced toxicity
The limit of CT-RT followed by durvalumab consolidation, leading to a high rate of recurrence within the 18 months (18-month PFS rate of 44.2%)
The strong rationale to combine RT and PD-1 inhibition

It is hypothesized this innovative concept to be safe in the context of this study for the following reasons:

The use of moderate accelerated intensity-modulated radiotherapy (H-IMRT) allows decreasing both the Overall Treatment Time (OTT) and the dose to the organs at risk
The decrease of the OTT (24 fractions instead of 33 fractions) combined with a decrease of the toxicity should represent a potential clinical benefit.

lead_sponsor: Center Eugene Marquis

sponsor_collaborators:
Center Eugene Marquis
Bristol-Myers Squibb

location_facility: Centre de Lutte Contre le Cancer François Baclesse

location_facility: Centre de Lutte contre le Cancer Oscar Lambret

intervention_type: Combination Product


title: Pre-operative Carriage of Respiratory VIRUSes, and Acute Respiratory Distress Syndrome After Heart Surgery - VIRUS-ATTAC

acronym: VIRUS-ATTAC

summary: The main objective of our study is to determine whether asymptomatic influenza virus carriage is associated with an increased risk of post-operative Acute Respiratory Distress Syndrome (ARDS) after cardiac surgery. Cardiac surgery patients are particularly at risk of developing ARDS with an estimated incidence of 5-10% based on the most recent data.

lead_sponsor: Rennes University Hospital

location_facility:
CHU Nantes
CHU Rennes
CHU Poitiers
APHP Henri Mondor
APHP La Pitié-Salpétrière

intervention_type: Diagnostic Test


title: The "Self Evaluation of Food Intake" (SEFI) as a Screening Test for Hospital Malnutrition in Children Over 10 Years

acronym: SEFI

summary: The goal is to find a simple tool that can be used by medical and paramedical staff and that is reliable to identify children at risk for malnutrition.

location_facility: APHP Trousseau Paris University Hospital


title: ICITRU : Randomized Trial of Immunonutrition With L-citrulline in Patients Hospitalized in Intensive Care for Sepsis or Septic Shock

acronym: ICITRU

summary:
Immunonutrition in intensive care has not yet demonstrated a beneficial effect on organ failure, the acquisition of nosocomial infections, or mortality. It did not correct for acquired immunosuppression in intensive care patients. Despite numerous methodological problems (use of several pharmaconutrients, very heterogeneous set of patients) and the absence of clinical data, deleterious effects have been attributed to immunonutrition in intensive care, in particular in septic patients and patients in intensive care . Arginine (ARG) is a semi-essential amino acid involved in many immunological mechanisms. It is synthesized in sufficient quantity under normal conditions but quickly becomes insufficient under catabolic conditions such as in severe sepsis. Arginine is not only the precursor of nitrogen monoxide (NO) but also an essential substrate for numerous enzymatic reactions which participate in the maintenance of immune homeostasis, in particular T lymphocyte function. Depletion of the cellular medium in arginine will induce an abnormality in the metabolism of immune cells responsible for a dysfunction of these cells (lymphopenia linked to early apoptosis) and thus expose patients to organ failure and nosocomial infections.

It has been found that hypoargininemia in intensive care patients is associated with the persistence of organ dysfunction (SOFA score), the occurrence of nosocomial infections and mortality. Also, it has been demonstrated that in these patients, enteral administration of ARG was not deleterious and increased ornithine synthesis, suggesting a preferential use of ARG via the arginases route, without significant increase in argininaemia or effect on immune functions. L-citrulline (CIT), an endogenous precursor of ARG, constitutes an interesting alternative for increasing the availability of ARG. Sponsor recent data demonstrate that the administration of CIT in intensive care is not deleterious and that it very significantly reduces mortality in an animal model of sepsis, corrects hypoargininemia, with convincing data on immunological parameters such as lymphopenia, which is associated with mortality, organ dysfunction and the occurrence of nosocomial infections. The availability of ARG directly impacts the mitochondrial metabolism of T lymphocytes and their function. Our hypothesis is therefore that CIT supplementation is more effective than administration of ARG in correcting hypoargininemia, reducing lymphocyte dysfunction, correcting immunosuppression and organ dysfunction in septic patients admitted to intensive care.

location_facility: Rennes University Hospital - Surgical ICU

location_facility: Rennes University Hospital - Medical ICU

nom_etablissement: CHRU RENNES

acronyme: ICITRU

titre: Essai randomisé d'immunonutrition par L-citrulline chez le patient hospitalisé en réanimation pour sepsis ou choc septique

discipline_principale: nutrition

nom_porteur: LESOUHAITIER

prenom_porteur: MATHIEU


title: Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis

summary:
Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative procedure using a high-intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation. Focal One® is a transrectal HIFU device, which is validated to treat prostatic cancer.

The primary objective of this clinical investigation is to evaluate the safety of the HIFU treatment of rectal endometriosis with Focal One® HIFU device.

lead_sponsor: EDAP TMS S.A.

location_facility:
Hopital de la Croix Rousse
Hôpital BICETRE
CHU de Angers
Clinique Tivoli-Ducos
Clinique de Gynécologie