A Study to Identify Participants With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations
Biomarker Study to Identify Subjects With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations
2 other identifiers
observational
3,679
14 countries
199
Brief Summary
The purpose of this non-interventional study is to identify participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations through molecular testing of their archival tumor tissue.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Typical duration for all trials
199 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
May 17, 2019
CompletedFirst Posted
Study publicly available on registry
May 20, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2022
CompletedFebruary 24, 2023
February 1, 2023
3.1 years
May 17, 2019
February 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations
Percentage of participants with selected FGFR gene aberrations will be assessed through molecular testing of their archival tumor tissue.
Up to 3.9 years
Study Arms (1)
Participants with Urothelial Cancer,selected FGFR aberrations
Participants with urothelial cancer (UC) will be evaluated for the prevalence of positive results of selected fibroblast growth factor receptor (FGFR) aberrations and will be assessed for eligibility status for erdafitinib studies. The primary data source for this study will be the medical records of each participant.
Interventions
Percentage of participants with UC and selected FGFR aberrations will be assessed through molecular testing of their archival tumor tissue.
Eligibility Criteria
Participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations.
You may qualify if:
- Transitional cell carcinoma of the urothelium. Urothelial cell carcinoma (UCC) variants are allowed, that is, UCC with squamous and/or glandular differentiation, micropapillary, nested, plasmacytoid, neuroendocrine, and sarcomatoid
- Diagnosis of one of the following: a) Metastatic or surgically unresectable urothelial cancer (UC) (Stage IV) or, b) localized surgically-resectable or resected UC with a T classification of T2 or above or non-muscle-invasive urothelial carcinoma of the bladder (Ta, T1 and carcinoma in situ \[CIS\])
- Available archival tissue sample for fibroblast growth factor receptor (FGFR) aberration analysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (199)
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85711, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Medical Oncology Hematology Consultants, PA
Newark, Delaware, 19713, United States
Affiliated Oncologists, LLC
Chicago Ridge, Illinois, 60415, United States
Maryland Oncology Hematology, PA
Brandywine, Maryland, 20613, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
New York Oncology Hematology
Albany, New York, 12206, United States
Broome Oncology
Johnson City, New York, 13790, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401, United States
Northwest Cancer Specialists PC
Tualatin, Oregon, 97062, United States
Consultants in Medical Oncology and Hematology, P.C. - Abington
Horsham, Pennsylvania, 19044, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology-Denton South
Denton, Texas, 76210, 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
Texas Oncology-Midland Allison Cancer Center
Midland, Texas, 79701, United States
University of Texas at San Antonio
San Antonio, Texas, 78217, United States
Texas Oncology-Sherman
Sherman, Texas, 75090, United States
Texas Oncology-Tyler
Tyler, Texas, 75702, United States
Texas Oncology -Waco
Waco, Texas, 76712, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
CIPREC
Buenos Aires, C1119ACN, Argentina
Investigaciones Clinico Moleculares (ICM)
CABA, C1425, Argentina
FUCDIM - Centro Urológico Modelo
Córdoba, 5008, Argentina
Sanatorio Allende Cerro
Córdoba, X5021FPQ, Argentina
Instituto Médico de Río Cuarto
Córdoba, X5800, Argentina
Hospital Privado de Cordoba
Córdoba, XX5016KEH, Argentina
Sanatorio Mayo SA
Santa Fe, S3000AZH, Argentina
Jolimont
Haine-Saint-Paul, La Louviere, 7100, Belgium
Az Groeninge
Kortrijk, 8500, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
ZNA Jan Palfijn
Merksem, 2170, Belgium
CHU UCL Namur - Site Sainte Elisabeth
Namur, 5000, Belgium
Clinique Saint Pierre
Ottignies, 1340, Belgium
CHPLT Verviers
Verviers, 4800, Belgium
NAIC - Nair Antunes Instituto do Câncer
Bauru, 17033-490, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150-221, Brazil
Nucleo de Ensino e Pesquisa do Instituto Mario Penna
Belo Horizonte, 30380-472, Brazil
Clinica de Oncologia Reichow
Blumenau, 89010-340, Brazil
Universidade Estadual De Campinas
Campinas, 13083-888, Brazil
Instituto Do Cancer Do Hospital Pompeia
Caxias do Sul, 95010-005, Brazil
Instituto de Oncologia do Paraná
Curitiba, 80530-010, Brazil
Ynova Pesquisa Clinica
Florianópolis, 88020-210, Brazil
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
Goiânia, 74605-070, Brazil
SCMI Santa Casa de Misericórdia de Itabuna
Itabuna, 45603-023, Brazil
Fundacao Doutor Amaral Carvalho
Jaú, 17210-080, Brazil
Cepeville - Centro de Hematologia e Oncologia
Joinville, 89201-260, Brazil
Hospital do Cancer de Londrina
Londrina, 86015, Brazil
Instituto Sensumed de Ensino e Pesquisa Ruy França - ISENP
Manaus, 69057-250, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90050-170, Brazil
Hospital Ernesto Dornelles
Porto Alegre, 90160-092, Brazil
IRPCC - Instituto Ribeiraopretano de Combate ao Cancer
Ribeirão Preto, 14015-130, Brazil
Núcleo de Oncologia da Bahia
Salvador, 40170-110, Brazil
Ensino e Terapia de Inovacao Clinica AMO - Etica
Salvador, 41950-640, Brazil
Centro de Pesquisa em Oncologia Onco SG
Santa Cruz do Sul, 96810110, Brazil
Hospital Paulistano
São Paulo, 01321-001, Brazil
Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas
Sorocaba, 18030-005, Brazil
Instituto do Cancer De Tres Lagoas
Três Lagoas, 79601-001, Brazil
Associacao Feminina de Educacao e Combate ao Cancer - Hospital Santa Rita de Cassia
Vitória, 29043-260, Brazil
CEDOES - Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda.
Vitória, 29055-450, Brazil
Polyclinique du Parc Rambot
Aix-en-Provence, 13090, France
CHU Amiens Picardie
Amiens, 80054, France
Hôpital Privé d'Anthony
Antony, 92160, France
Institut Sainte Catherine
Avignon, 84918, France
Centre Hospitalier de Boulogne-sur-Mer
Boulogne-sur-Mer Cédex, 62321, France
Hôpital de Fleyriat
Bourg-en-Bresse, 01012, France
Centre Hospitalier Dr Jean-Eric TECHER
Calais, 62100, France
CH Chambéry
Chambéry, 73000, France
Centre Hospitalier Alpes Léman
Contamine-sur-Arve, 74130, France
Institut Andree DUTREIX
Dunkirk, 59240, France
Centre Hospitalier Annecy Genevois
Epagny Metz-Tessy, 74370, France
Centre Hospitalier Eure-Seine - Hopitaux d'Evreux - Vernon
Évreux, 27015, France
Clinique de la Sauvegarde
Lyon, 69009, France
Hôpital Privé Clairval
Marseilli, 13009, France
Ch De St Quentin
Saint-Quentin, 2321, France
Hôpital Privé Drome Ardèche
Valence, 26000, France
Ch Bretagne Atlantique De Vannes
Vannes, 56017, France
Markus Krankenhaus Frankfurt
Frankfurt, 60431, Germany
Prostata zentrum Nordwest
Gronau, 48599, Germany
Marien hospital Herne
Herne, 44625, Germany
MVZ Urologie 24 gGmbH
Nuremberg, 90491, Germany
ELBLANDKLINIKUM Riesa
Riesa, 1589, Germany
Hegau Klinikum Singen
Singen, 78224, Germany
Urologischen Praxisgemeinschaft
Wolfsburg, 38440, Germany
Haemek Medical Center - Afula
Afula, 1834111, Israel
Carmel Medical Center
Haifa, 3436212, Israel
Azienda Ulss 6 Euganea- Ospedale Di Camposampiero
Camposampiero, 35012, Italy
Ospedale Di Carrara
Carrara, 54033, Italy
Fondazione Istituto G. Giglio
Cefalù, 90015, Italy
Hospital SS Annunziata - University G.D'Annunzio
Chieti, 66100, Italy
Ospedale Città Di Castello
Città di Castello, 06012, Italy
Az. USL 12 di Viareggio Ospedale Versilia
Lido di Camaiore, Italy
Ospedale San Luca
Lucca, 55100, Italy
Azienda Ospedaliera Carlo Poma
Mantova, 46100, Italy
Azienda Ospedaliera Ospedale San Carlo Borromeo
Milan, 20153, Italy
Ospedale Civile di Mirano
Mirano (VE), 30035, Italy
Azienda Ospedaliera 'A. Cardarelli'
Napoli, 80131, Italy
Ospedale Buccheri La Ferla Fatebenefratelli
Palermo, 90123, Italy
A.O.R Villa Sofia Cervello
Palermo, 90146, Italy
Casa di Cura La Maddalena
Palermo, 90146, Italy
Policlinico San Pietro
Ponte San Pietro, 24100, Italy
Nuovo Ospedale Di Prato - S. Stefano
Prato, 59100, Italy
Asst Rhodense - Ospedale Di Rho
Rho, 20017, Italy
Polo Ospedaliero Unico Integrato- Presidio S.Camillo De Lellis Di Rieti
Rieti, 20100, Italy
Istituto Nazionale Tumori Regina Elena
Roma, 00144, Italy
Ospedale Generale Provinciale - Saronno
Saronno, 21047, Italy
Ospedale Bolognini
Seriate, 24020, Italy
Ospedale Treviglio-Caravaggio
Treviglio, 24047, Italy
SC Oncologia ASL CN2
Verduno (CN), 12060, Italy
Azienda Ulss 8 Berica- Ospedale Di Vicenza
Vicenza, 36100, Italy
Azienda Ospedaliera "Ospedale Civile" di Vimercate - Ospedal
Vimercate, 20087, Italy
The Jikei University Kashiwa Hospital
Chiba, 277 -8567, Japan
Juntendo University Hospital Urayasu
Chiba, 279-0021, Japan
National Hospital Organization Mito Medical Center
Higashiibaraki-gun, 311-3193, Japan
Teine Keijinkai Hospital
Hokkaido, 006-8555, Japan
Hitachinaka General Hospital
Ibaraki, 3120057, Japan
Ikeda City Hospital
Ikeda, 563-8510, Japan
Japanese Red Cross Ise Hospital
Ise, 516-8512, Japan
Isesaki Municipal Hospital
Isesaki, 372-0817, Japan
Kaizuka City Hospital
Kaizuka, 597-0015, Japan
Kanagawa Cancer Center
Kanagawa, 241-8515, Japan
Mitoyo General Hospital
Kan’onjichō, 769-1695, Japan
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, 586-8521, Japan
Kiryu Kosei General Hospital
Kiryū, 376-0024, Japan
Kimitsu Chuo Hospital
Kisarazu-shi, 292-8535, Japan
Saitama Cancer center
Kitaadachi-gun, 362-0806, Japan
Kitasato University Medical Center
Kitamoto, 364-8501, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, 343-8555, Japan
Kitasato University Kitasato Institute Hospital
Minatoku, 108-8642, Japan
Japanese Red Cross Mito Hospital
Mito, 310-0011, Japan
Japanese Red Cross Narita Hospital
Narita, 286-8523, Japan
Juntendo University Nerima Hospital
Nerima-Ku, 177-8521, Japan
Kobe City Nishi-Kobe Medical Center
Nishiku, 651-2273, Japan
National Hospital Organization Osaka National Hospital
Osaka, 540-0006, Japan
Otemae Hospital
Osaka, 540-0008, Japan
Osaka Police Hospital
Osaka, 543-0035, Japan
Osaka General Medical Center
Osaka, 558-8558, Japan
JOHAS Osaka Rosai Hospital
Osaka, 591-8025, Japan
SUBARU Health Insurance Society Ota Memorial Hospital
Ōta-ku, 373-8585, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, 252-0392, Japan
Sakai City Medical Center
Sakai, 593-8304, Japan
Jinyukai Hospital
Sapporo, 005-0002, Japan
Mitsui Memorial Hospital
Tokyo, 101-8643, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Tokyo, 113-8677, Japan
Tsuchiura Kyodo General Hospital
Tsuchiura, 300-0028, Japan
Tsukuba Medical Center Hospital
Tsukuba, 305-8558, Japan
State Budgetary Healthcare Institution Inter-regional Multi-specialty Hospital
Anzorey, 361336, Russia
LLC Evimed
Chelyabinsk, 454048, Russia
FSBI A.V. Vishnevsky National Medical Research Center of Surgery of the MoH RF
Moscow, 17997, Russia
LLC 1 named after Berezin Sergey
Saint Petersburg, 194354, Russia
Oncology Medical Clinics AV Medical group
Saint Petersburg, 196006, Russia
Komi Republican Oncology Dispensary
Syktivkar, 167094, Russia
Tomsk National Research Medical Center of the Russian Academy of Sciences
Tomsk, 634009, Russia
Yaroslavl Regional Clinical Oncology Hospital
Yaroslavl, 150054, Russia
SHI Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, 620102, Russia
Hosp. Univ. Fundacion Alcorcon
Alcorcón, 28922, Spain
Hosp. Gral. de Granollers
Barcelona, 08400, Spain
Hosp. Puerta Del Mar
Cadiz, 11009, Spain
Hosp. Univ. Donostia
Donostia / San Sebastian, 20080, Spain
Genesiscare Jerez de La Frontera
Jerez de la Frontera, 11407, Spain
Hosp. Univ. de La Princesa
Madrid, 28006, Spain
Hosp. Univ. Del Henares
Madrid, 28822, Spain
Hosp. Univ. Central de Asturias
Oviedo, 33011, Spain
Hosp. Univ. Infanta Sofia
San Sebastián de los Reyes, 28702, Spain
Hosp. Quiron Sagrado Corazon
Seville, 41013, Spain
Hosp. de Terrassa
Terrassa, 08227, Spain
Hosp. Virgen de La Salud
Toledo, 45004, Spain
Adana Acibadem Hospital
Adana, 1130, Turkey (Türkiye)
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 6200, Turkey (Türkiye)
Adnan Menderes University Training and Research Hospital
Aydin, 09100, Turkey (Türkiye)
Canakkale Onsekiz Mart University Health Practices and Research Hospital
Çanakkale, 17110, Turkey (Türkiye)
Şişli Etfal Research Training Hospital
Istanbul, 34371, Turkey (Türkiye)
Haydarpasa Numune Training and Research Hospital
Istanbul, 34668, Turkey (Türkiye)
Kartal Dr. Lutfi Kirdar Egitim ve Arastirma Hastanesi
Istanbul, 34890, Turkey (Türkiye)
Izmir Katip Celebi University Ataturk Training and Research Hospital
Izmir, 35360, Turkey (Türkiye)
Izmir Medical Park Hospital
Izmir, 35575, Turkey (Türkiye)
Derince Egitim ve Arastirma Hastanesi
Kocaeli, 41900, Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty
Konya, 42080, Turkey (Türkiye)
Manisa Celal Bayar University
Manisa, 45030, Turkey (Türkiye)
Medical Park Samsun Hastanesi
Samsun, 55200, Turkey (Türkiye)
Ondokuz Mayis University
Samsun, 55200, Turkey (Türkiye)
Municipal Non-profit enterprise 'Bukovinian clinical oncology center'
Chernivtsi, 58013, Ukraine
Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council
Kamianske, 51900, 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
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
Medical Center 'Diaservis'
Zaporizhzhia, 69076, Ukraine
Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council
Zhytomyr, 10002, Ukraine
Colchester Hospital University NHS
Colchester, CO4 5JL, United Kingdom
Royal Devon & Exeter Hospital
Exeter, EX2 5DW, United Kingdom
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Queen Alexandra Hospital
Portsmouth, PO6 3LY, United Kingdom
Royal Preston Hospital
Preston, PR2 9HT, United Kingdom
MeSH Terms
Conditions
Condition 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
May 17, 2019
First Posted
May 20, 2019
Study Start
August 1, 2019
Primary Completion
September 19, 2022
Study Completion
September 19, 2022
Last Updated
February 24, 2023
Record last verified: 2023-02