A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
2 other identifiers
observational
14,532
24 countries
330
Brief Summary
The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair gene defects in a population of men with metastatic Prostate Cancer (PC) and to use the reported DNA-repair gene defects to assess biomarker eligibility for niraparib interventional studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2019
Typical duration for all trials
330 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2019
CompletedFirst Posted
Study publicly available on registry
March 12, 2019
CompletedStudy Start
First participant enrolled
April 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2022
CompletedDecember 11, 2023
December 1, 2023
3.5 years
March 11, 2019
December 8, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Prostate Cancer as an Estimate for Prevalence
Percentage of participants with 4 or more Deoxyribonucleic acid (DNA)-repair gene defects with metastatic Prostate Cancer (PC) as an estimate for prevalence will be assessed. A saliva, blood, and/or archival tumor tissue sample will be collected for genomic testing to confirm DNA-repair gene defect (DRD) status.
Approximately 2.4 years
Percentage of Participants who Meet Biomarker Eligibility Criteria for Other Niraparib Interventional Studies
Percentage of participants who meet biomarker eligibility criteria for other niraparib interventional studies will be assessed.
Approximately 2.4 years
Secondary Outcomes (2)
Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) and with Metastatic Hormone Sensitive PC (HSPC) as an Estimate for Prevalence
Approximately 2.4 years
Percentage of Participants with 1 or more DNA-repair gene defects with Metastatic Prostate Cancer as an Estimate for Prevalence
Approximately 2.4 years
Study Arms (1)
Participants with Metastatic Prostate Cancer
Participants with metastatic prostate Cancer (PC) will be evaluated for the prevalence of DNA-repair gene defects (DRDs) and will be assessed for biomarker eligibility status for niraparib interventional studies. Participants will be consented to saliva, blood, and/or archival tumor tissue testing for the presence or absence of DNA-repair gene defects.
Interventions
Saliva, blood, and/or archival tumor tissue will be collected from the participants with metastatic PC for genomic testing to confirm DRD status.
Eligibility Criteria
Study population consists of male participants diagnosed with metastatic prostate cancer who will be evaluated for the prevalence for DNA-repair gene defects.
You may qualify if:
- Diagnosis of metastatic (Stage IV) prostate cancer (PC), confirmed by either biopsy of a metastatic tumor site or history of localized disease supported by metastatic disease on imaging studies (that is \[i.e.\], clearly noted in hospital/clinical records)
- Signed Informed consent form (ICF)
- No condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example \[e.g.\], compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Willing to provide a saliva, blood, and/or archival tumor tissue sample for genomic analysis
- No prior poly (adenosine diphosphate \[ADP\]-ribose) polymerase inhibitor (PARPi) for the treatment of prostate cancer
- No prior DNA-repair gene defect test results from a Janssen sponsored interventional trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (338)
Urology Centers Of Alabama
Homewood, Alabama, 35209, United States
Southern Cancer Center, PC
Mobile, Alabama, 36608, United States
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, 85016, United States
Mayo Clinic
Phoenix, Arizona, 85054, United States
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, 85741, United States
Yuma Regional Medical Center
Yuma, Arizona, 85364, United States
Arkansas Urology
Little Rock, Arkansas, 72211, United States
MemorialCare Research Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806, United States
Kaiser Permanente
Riverside, California, 92505, United States
San Bernardino Urological Associates
San Bernardino, California, 92506, United States
Sansum Clinic Pharm
Santa Barbara, California, 93105, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
The Urology Center of Colorado
Denver, Colorado, 80211, United States
Foothills Urology - Golden Off
Golden, Colorado, 80401, United States
Eastern Connecticut Hematology & Oncology Assoc.
Norwich, Connecticut, 06360, United States
Advanced Urology Institute
Daytona Beach, Florida, 32114, United States
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
Fort Lauderdale, Florida, 33308-4668, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256, United States
Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
Miami, Florida, 33176, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Woodlands Medical Specialists, PA
Pensacola, Florida, 32503, United States
University Cancer & Blood Center, LLC
Athens, Georgia, 30607, United States
Hawaii Cancer Care
Honolulu, Hawaii, 96813, United States
Affiliated Oncologists, LLC
Chicago Ridge, Illinois, 60415, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46804, United States
First Urology
Jeffersonville, Indiana, 47130, United States
Beacon Medical Group Clinical Research
South Bend, Indiana, 46601, United States
Norton Healthcare
Louisville, Kentucky, 40202, United States
Pontchartrain Cancer Center
Covington, Louisiana, 70433, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Maryland Oncology Hematology, PA
Columbia, Maryland, 21044, United States
Frederick Health Hospital - James M Stockman Cancer Institute
Frederick, Maryland, 21702-4337, United States
Chesapeake Urology Associates
Towson, Maryland, 21204, United States
Beth Israel Deaconess Hospital Plymouth, Jordan Club Cancer Center
Plymouth, Massachusetts, 02360, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Edward W Sparrow Hospital
Lansing, Michigan, 48219, United States
Michigan Institute of Urology
Troy, Michigan, 48084, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
Central Care Cancer Center
Bolivar, Missouri, 65613, United States
Mosaic Life Care
Saint Joseph, Missouri, 64507, United States
Adult Pediatric Urology & Urogynecology, P.C
Omaha, Nebraska, 68114, United States
GU Research Network
Omaha, Nebraska, 68130, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
New York Oncology Hematology
Albany, New York, 12208, United States
Tisch Cancer Institution
New York, New York, 10029, United States
Associated Medical Professionals
Syracuse, New York, 13210, United States
Upstate Cancer Center
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534, United States
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, 74146, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401, United States
Northwest Cancer Specialists PC
Portland, Oregon, 97213-2982, United States
Oregon Oncology Specialists
Salem, Oregon, 97301, United States
Oregon Urology Institute
Springfield, Oregon, 97477, United States
Centers for Advanced Urology LLC d b a MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Consultants in Medical Oncology and Hematology, P.C. - Abington
Horsham, Pennsylvania, 19044, United States
Lancaster Urology
Lancaster, Pennsylvania, 17601, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15232, United States
Prisma Health
Greenville, South Carolina, 29615, United States
Atlantic Urology Clinics
Myrtle Beach, South Carolina, 29572, United States
Texas Onc.
Abilene, Texas, 79606, United States
Texas Oncology-Amarillo
Amarillo, Texas, 79106, United States
Texas Oncology-Austin
Austin, Texas, 78731, United States
Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center
Beaumont, Texas, 77702-1449, United States
Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
Texas Oncology-Denton South
Denton, Texas, 76201, United States
Texas Oncology, P.A. - Flower Mound
Flower Mound, Texas, 75028, United States
Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas, 76104, United States
Texas Oncology-Memorial City
Houston, Texas, 77024, United States
Houston Metro Urology
Houston, Texas, 77027, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Oncology - Willowbrook
Houston, Texas, 77070, United States
Texas Oncology P.A.
Longview, Texas, 75601, United States
Texas Oncology P.A.
McAllen, Texas, 78503, United States
Texas Oncology-Mesquite
Mesquite, Texas, 75150, United States
Texas Oncology-Midland Allison Cancer Center
Midland, Texas, 79701, United States
Texas Oncology, P.A. - Paris
Paris, Texas, 75460, United States
Texas Oncology P A
Plano, Texas, 75075, United States
Texas Oncology P.A.
Plano, Texas, 75093, United States
University of Texas at San Antonio
San Antonio, Texas, 78217, United States
Texas Oncology -Waco
Waco, Texas, 76712, United States
Texas Oncology Deke Slayton Cancer Center
Webster, Texas, 77598, United States
Texas Oncology P.A.
Wichita Falls, Texas, 76310, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
INOVA
Fairfax, Virginia, 22031, United States
Virginia Cancer Specialists
Leesburg, Virginia, 20176, United States
Virginia Oncology Asc
Norfolk, Virginia, 23502, United States
Urology of Virginia, PLCC
Virginia Beach, Virginia, 23462, United States
Northwest Medical Specialists
Tacoma, Washington, 98405, United States
Building Oncology Research
Janesville, Wisconsin, 53548, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Hospital Aleman
Buenos Aires, C1118AAT, Argentina
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
Buenos Aires, C1419AHN, Argentina
Centro Oncológico Korben
Buenos Aires, C1426AGE, Argentina
CEMIC Saavedra
Buenos Aires, C1431FWN, Argentina
CINME - Centro de Investigaciones Metabolicas
Caba, C1027AAP, Argentina
Centro de Urologia (CDU)
Ciudad Automoma Buenos Aires, C1120AAT, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma de, C1199ABB, Argentina
Clínica Adventista Belgrano
Ciudad de Buenos Aires, C1430EGF, Argentina
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, 5000, Argentina
Centro Urologico Profesor Bengio
Córdoba, X5000KPH, Argentina
Hospital Privado - Centro Medico de Cordoba
Córdoba, X5016KEH, Argentina
Hospital Privado de Comunidad
Mar del Plata, B7602CBM, Argentina
Centro de Investigacion Pergamino SA
Pergamino, B2700CPM, Argentina
Sanatorio Parque
Rosario, S2000SDV, Argentina
ARS Médica
San Salvador de Jujuy, Y4600AFW, Argentina
Pindara Private Hospital
Benowa, 4217, Australia
Sunshine Coast University Hospital
Birtinya, 4575, Australia
Chris O'Brien Lifehouse
Camperdown, 2050, Australia
St Vincent's hospital
Darlinghurst, 2010, Australia
Border Medical Oncology
East Albury, 2640, Australia
Royal Hobart Hospital
Hobart, 7000, Australia
Ashford Cancer Centre
Kurralta Park, 5037, Australia
Liverpool Hospital
Liverpool, 2170, Australia
Macquarie University Hospital
Macquarie University, 2109, Australia
Peter MacCallum Cancer Centre
Melbourne, 3000, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
Prince Of Wales Hospital
Randwick, 2031, Australia
Sydney Adventist Hospital
Wahroonga, 2076, Australia
Bobruisk Interregional Oncological Dispensary
Babruysk, 213825, Belarus
Brest Regional Oncology Dispensary
Brest, 224027, Belarus
Grodno University Hospital
Grodno, 230017, Belarus
Gomel Regional Clinical Oncology Dispensary
Homyel, 246012, Belarus
State Institution N.N. Alexandrov Republican Scientific and
Lesnoy, 223040, Belarus
Minsk city Clinical Oncological Dispensary
Minsk, 220013, Belarus
Mogilev Regional Hospital
Mogilev, 212018, Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, 210603, Belarus
Clinique Notre Dame de Grâce
Charleroi, 6000, Belgium
Jolimont
Haine-Saint-Paul, La Louviere, 7100, Belgium
Clinique Saint Pierre
Ottignies, 1340, Belgium
Algemeen Ziekenhuis Delta
Roeselare, 8800, Belgium
Fundacao Pio XII
Barretos, 14784-400, Brazil
Cetus Oncologia
Belo Horizonte, 30110-022, Brazil
PERSONAL - Oncologia de Precisão e Personalizada
Belo Horizonte, 30130-090, Brazil
Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia
Brasília, 7020-730, Brazil
CIONC - Centro Integrado de Oncologia de Curitiba
Curitiba, 80810-050, Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, 81520-060, Brazil
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
Florianópolis, 88034-000, Brazil
Suporte Nutricional e Quimioterapia Ltda-Pronutrir
Fortaleza, 60 810180, Brazil
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
Goiânia, 74605-070, Brazil
Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
Ijuí, 98700-000, Brazil
Fundação São Francisco Xavier
Ipatinga, 35162 189, Brazil
Clínica de Neoplasias Litoral Ltda.
Itajaí, 88301-220, Brazil
Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia
Joinville, 89201-260, Brazil
Medradius Clinica de Medicina Nuclear e Radiologia de Maceio Ltda.
Maceió, 57052-765, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062-000, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90020-090, Brazil
Hospital Ernesto Dornelles
Porto Alegre, 90160-093, Brazil
MultiHemo Servicos Medicos S.A
Recife, CEP: 50070-460, Brazil
Universidade do Estado do Rio de Janeiro - UERJ
Rio de Janeiro, 20551-030, Brazil
Oncoclínicas Rio de Janeiro S.A.
Rio de Janeiro, 22250-905, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, 22775-001, Brazil
Nucleo de Oncologia da Bahia
Salvador, 40170-110, Brazil
Hospital Sao Rafael
Salvador, 41253-190, Brazil
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, 09060-650, Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho
São Paulo, 01221-020, Brazil
Irmandade Santa Casa de Misericordia de Sao Paulo
São Paulo, 01221-020, Brazil
Instituto de Ensino e Pesquisa São Lucas
São Paulo, 01236-030, Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246-000, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, 01323-900, Brazil
Fundacao Antonio Prudente - A.C. Camargo Cancer Center
São Paulo, 01509900, Brazil
Núcleo de Pesquisa São Camilo
São Paulo, 04014-002, Brazil
Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
São Paulo, 04039-004, Brazil
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
Sorocaba, 18030-075, Brazil
Instituto do Cancer De Tres Lagoas
Três Lagoas, 79601-001, Brazil
MHAT Deva Maria
Burgas, 8001, Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, 5800, Bulgaria
District Oncology Dispensary with In-Patient Stationary - Plovdiv
Plovdiv, 4004, Bulgaria
Comprehensive Cancer Center
Vratsa, 3001, Bulgaria
Southern Alberta Institute of Urology / Prostate Cancer Centre
Calgary, Alberta, T2V 1P9, Canada
British Columbia Cancer Agency (BCCA) - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6, Canada
British Columbia Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, V8R 6V5, Canada
McMaster Institute of Urology
Hamilton, Ontario, L8N 4A6, Canada
Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)
Kingston, Ontario, K7L 3N6, Canada
University Health Network (UHN) Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Centre de Recherche du CHUM
Montreal, Quebec, H2X 0A9, Canada
Centre hospitalier universitaire de Québec (CHUQ), L'Hotel-Dieu de Quebéc
Québec, Quebec, G1R2J6, Canada
Copenhagen University Hospital
Copenhagen, 2100, Denmark
Næstved Hospital
Næstved, 4700, Denmark
Institut Sainte Catherine
Avignon, 84918, France
Centre Hospitalier Regional Universitaire Besancon
Besançon, 25030, France
Institut Bergonié
Bordeaux, 33000, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Oscar Lambret
Lille, 59020, France
Centre Leon Bérard
Lyon, 69008, France
Polyclinique de Gentilly
Nancy, 54100, France
Centre Antoine Lacassagne
Nice, 6189, France
Hopital Europeen Georges-Pompidou
Paris, 75908, France
Institut de Cancérologie de l'Ouest (ICO)
Saint-Herblain, 44805, France
HIA Begin
Saint-Mandé, 94163, France
Institut de Cancérologie de Loire
Saint-Priest-en-Jarez, 42271, France
Clinique Sainte Anne
Strasbourg, 67000, France
Hôpitaux Universitaire de Strasbourg -CHU
Strasbourg, 67091, France
Hopital Foch
Suresnes, 32151, France
CHRU de Tours
Tours, 37044, France
Institut Gustave Roussy
Villejuif, 94805, France
Urologisches Zentrum Bonn
Bonn, 53111, Germany
Urologie im Schlosscarree Schreier/Eichler/Junius - Germany
Braunschweig, 38100, Germany
Zeisigwaldkliniken Bethanien Chemnitz
Chemnitz, 09130, Germany
Urologische Gemeinschaftspraxis Böhm/Linne - Germany
Dresden, 01307, Germany
uro Eimsbüttel - Gemeinschaftspraxis Bath/Weinzierl
Hamburg, 20255, Germany
Klinikum Region Hannover Klinikum Siloah
Hanover, 30459, Germany
Matthias Schulze - Germany
Markkleeberg, 04416, Germany
CUROS - Uberörtliche urologische Gemeinschaftspraxis
Wesseling, 50389, Germany
Soroka Hospital
Beersheba, 85101, Israel
Rambam Hospital
Haifa, 31096, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Sheba Medical Center
Ramat Gan, 74047, Israel
Asaf Harofe Medical Center
Zrifin, 60930, Israel
Ospedale Cardinal Massaia
Asti, 14100, Italy
Ospedale Sacro Cuore Di Gesu
Benevento, 82100, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127, Italy
Ospedale di Bolzano
Bolzano, 39100, Italy
oncologia medica - Oncology
Brindisi, 72100, Italy
Azienda Ulss 6 Euganea- Ospedale Di Camposampiero
Camposampiero, 35012, Italy
Ospedale Di Carrara
Carrara, 54033, Italy
AORN Sant'anna e San Sebastiano
Caserta, 81100, Italy
ASST -Ospedale Maggiore di Crema
Crema, 26013, Italy
Azienda ULSS 3 Serenissima, presidio di Mirano
Mirano, 30035, Italy
PP.OO. di Piombino e Portoferraio Azienda USL Toscana nord ovest
Piombino, 57025, Italy
Ospedale degli Infermi
Ponderano, 13875, Italy
Ospedale del Mare ASL Napoli 1 centro
Ponticelli, 80147, Italy
Azienda ULSS5 Polesana di Rovigo - Ospedale Santa Maria della Misericordia
Rovigo, 45100, Italy
PO Ospedale S.Anna, ASST Lariana
San Fermo della Battaglia, 22042, Italy
Hospital Pulau Pinang
George Town, 10990, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Sarawak General Hospital
Kuching, 93586, Malaysia
Renier de Graaf
Delft, 2625 AD, Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, 6524 KD, Netherlands
Elisabeth-TweeSteden Ziekenhuis
Tilburg, 5022 GC, Netherlands
Centrum Onkologii im. Prof. F. Lukaszczyka
Bydgoszcz, 85-796, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Szpitale Pomorskie Sp. z o.o.
Gdynia, 81-519, Poland
Przychodnia Lekarska KOMED Roman Karaszewski
Konin, 62-500, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, 93-513, Poland
Urologica Praktyka Lekarska Adam Marcheluk
Siedlce, 08-110, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.
Warsaw, 04-073, Poland
Specjalistyczna przychodnia lekarska POLIMED
Wroclaw, 53-329, Poland
Altai Regional Oncology Dispensary
Barnaul, 656045, Russia
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
Chelyabinsk, 454087, Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, 153040, Russia
Russian Scientific Center of Roentgenoradiology
Moscow, 117997, Russia
Moscow City Clinical Hospital # 62
Moscow, 125130, Russia
Hertzen Oncology Research Institute
Moscow, 125284, Russia
Privolzhsky District Medical Centre
Nizhny Novgorod, 603074, Russia
Clinical Oncology Dispensary
Omsk, 644013, Russia
Pyatigorsk Interdistrict Oncology Dispensary
Pyatigorsk, 357502, Russia
Leningrad Regional Oncology Dispensary
Saint Petersburg, 191104, Russia
Republican Oncology Dispensary
Saransk, 430032, Russia
Multifunctional clinical medical center 'Medical city'
Tyumen, 625041, Russia
Bashkir State Medical University
Ufa, 450008, Russia
Pusan National University Hospital
Busan, 49241, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
Ajou University Hospital
Gyeonggi-do, 16499, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Hosp. Univ. A Coruna
A Coruña, 15006, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hosp. Clinic de Barcelona
Barcelona, 08036, Spain
Hosp. Gral. Univ. de Castellon
Castellon, 12004, Spain
Institut Català D'Oncologia Girona
Girona, 17007, Spain
Hosp. Univ. de Jaen
Jaén, 23007, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407, Spain
Hosp. Univ. Arnau de Vilanova de Lleida
Lleida, 25198, Spain
Hosp. Univ. de La Princesa
Madrid, 28006, Spain
Hosp. Univ. Infanta Leonor
Madrid, 28031, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp. Univ. Hm Monteprincipe
Madrid, 28660, Spain
Hosp. Univ. Del Henares
Madrid, 28822, Spain
Hosp. Virgen de La Victoria
Málaga, 29010, Spain
Complexo Hosp. Univ. de Ourense
Ourense, 32005, Spain
Hosp. Univ. Infanta Cristina
Parla, Madrid, 28981, Spain
Hosp. Puerto Real
Puerto Real, Cádiz, 11510, Spain
Corporacio Sanitari Parc Tauli
Sabadell, 08208, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Hosp. de Sant Pau I Santa Tecla
Tarragona, 43003, Spain
Hosp. de Terrassa
Terrassa, 08227, Spain
Hosp. Clinico Univ. de Valencia
Valencia, 46010, Spain
Skanes universitetssjukhus
Malmo, 20502, Sweden
Södersjukhuset
Stockholm, 11883, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 88301, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Tungs' Taichung MetroHarbor Hospital
Taichung, 435, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
Chi Mei Medical Center - Yong Kang
Tainan, 710, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Chang Gung Memorial Hospital
Taoyuan District, 33305, Taiwan
Ramathibodi Hospital
Bangkok, 10400, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, 10500, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06200, Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, 06520, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 06800, Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, 07070, Turkey (Türkiye)
Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi
Bursa, 16310, Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, 22030, Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty
Istanbul, 34000, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
Istanbul, 34098, Turkey (Türkiye)
T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Izmir Medical Park Hospital
Izmir, 35580, Turkey (Türkiye)
Sakarya University Training and Research Hospital
Sakarya, 54100, Turkey (Türkiye)
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
Cherkasy, 18009, Ukraine
Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
Dnipo, 49005, Ukraine
Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council
Dnipro, 49100, Ukraine
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, 76008, Ukraine
Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council
Kamianske, 51900, Ukraine
Municipal non-profit enterprise 'Regional Center of Oncology'
Khakhiv, 61070, Ukraine
Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval
Kharkiv, 61037, Ukraine
Khmelnitckiy regional hospital
Khmelnytsky, 29000, Ukraine
Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council'
Kropyvnytskyi, 25011, Ukraine
National Cancer Institute
Kyiv, 03022, Ukraine
State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
Kyiv, 03115, Ukraine
Lviv Clinical Regional Hospital
Lviv, 79031, Ukraine
ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'
Poltava, 36024, Ukraine
Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
Uzhhorod, 88000, Ukraine
Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council
Zhytomyr, 10002, Ukraine
Royal Blackburn Hospital
Blackburn, BB2 3HH, United Kingdom
Royal Marsden Hospital
London, SW7 3RP, United Kingdom
University College London Hospitals
London, WC1E 6BT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2019
First Posted
March 12, 2019
Study Start
April 22, 2019
Primary Completion
October 30, 2022
Study Completion
November 22, 2022
Last Updated
December 11, 2023
Record last verified: 2023-12