A Study to Identify Participants With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations

February 23, 2023 updated by: Janssen Research & Development, LLC

Biomarker Study to Identify Subjects With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Other: Archival Tumor Tissue Sample

Study Type

Observational

Enrollment (Actual)

3679

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1119ACN
    - CIPREC
  - Caba, Argentina, C1425
    - Investigaciones Clinico Moleculares (ICM)
  - Cordoba, Argentina, X5021FPQ
    - Sanatorio Allende Cerro
  - Cordoba, Argentina, X5800
    - Instituto Médico de Río Cuarto
  - Cordoba, Argentina, XX5016KEH
    - Hospital Privado de Cordoba
  - Córdoba, Argentina, 5008
    - FUCDIM - Centro Urológico Modelo
  - Santa Fe, Argentina, S3000AZH
    - Sanatorio Mayo SA
Belgium
- - Haine-Saint-Paul, La Louviere, Belgium, 7100
    - Jolimont
  - Kortrijk, Belgium, 8500
    - AZ Groeninge
  - Liege, Belgium, 4000
    - CHU de Liège - Domaine Universitaire du Sart Tilman
  - Merksem, Belgium, 2170
    - ZNA Jan Palfijn
  - Namur, Belgium, 5000
    - CHU UCL Namur - Site Sainte Elisabeth
  - Ottignies, Belgium, 1340
    - Clinique Saint Pierre
  - Verviers, Belgium, 4800
    - CHPLT Verviers
Brazil
- - Bauru, Brazil, 17033-490
    - NAIC - Nair Antunes Instituto do Câncer
  - Belo Horizonte, Brazil, 30150-221
    - Santa Casa de Misericordia de Belo Horizonte
  - Belo Horizonte, Brazil, 30380-472
    - Nucleo de Ensino e Pesquisa do Instituto Mario Penna
  - Blumenau, Brazil, 89010-340
    - Clínica de Oncologia Reichow
  - Campinas, Brazil, 13083-888
    - Universidade Estadual de Campinas
  - Caxias Do Sul, Brazil, 95010-005
    - Instituto Do Cancer Do Hospital Pompeia
  - Curitiba, Brazil, 80530-010
    - Instituto de Oncologia do Parana
  - Florianopolis, Brazil, 88020-210
    - Ynova Pesquisa Clinica
  - Goiania, Brazil, 74605-070
    - Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
  - Itabuna, Brazil, 45603-023
    - SCMI Santa Casa de Misericórdia de Itabuna
  - Jau, Brazil, 17210-080
    - Fundacao Doutor Amaral Carvalho
  - Joinville, Brazil, 89201-260
    - Cepeville - Centro de Hematologia e Oncologia
  - Londrina, Brazil, 86015
    - Hospital do Câncer de Londrina
  - Manaus, Brazil, 69057-250
    - Instituto Sensumed de Ensino e Pesquisa Ruy França - ISENP
  - Porto Alegre, Brazil, 90050-170
    - Irmandade Santa Casa de Misericordia de Porto Alegre
  - Porto Alegre, Brazil, 90160-092
    - Hospital Ernesto Dornelles
  - Ribeirao Preto, Brazil, 14015-130
    - IRPCc - Instituto Ribeirãopretano de Combate ao Câncer
  - Salvador, Brazil, 40170-110
    - Nucleo de Oncologia da Bahia
  - Salvador, Brazil, 41950-640
    - Ensino E Terapia de Inovação Clínica Amo - Ética
  - Santa Cruz Do Sul, Brazil, 96810110
    - Centro de Pesquisa em Oncologia Onco SG
  - Sorocaba, Brazil, 18030-005
    - Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas
  - São Paulo, Brazil, 01321-001
    - Hospital Paulistano
  - Três Lagoas, Brazil, 79601-001
    - Instituto do Cancer De Tres Lagoas
  - Vitoria, Brazil, 29043-260
    - Associacao Feminina de Educacao e Combate ao Cancer - Hospital Santa Rita de Cassia
  - Vitoria, Brazil, 29055-450
    - CEDOES - Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda.
France
- - Aix En Provence, France, 13090
    - Polyclinique du parc Rambot
  - Amiens Cedex 1, France, 80054
    - CHU Amiens Picardie
  - Antony, France, 92160
    - Hôpital privé d'Anthony
  - Avignon Cedex 9, France, 84918
    - Institut Sainte Catherine
  - Boulogne-sur-Mer Cédex, France, 62321
    - Centre Hospitalier de Boulogne-Sur-Mer
  - Bourg en Bresse, France, 01012
    - Hôpital de Fleyriat
  - Calais, France, 62100
    - CENTRE HOSPITALIER Dr Jean-Eric TECHER
  - Chambery, France, 73000
    - CH Chambéry
  - Contamine-Sur-Arve, France, 74130
    - Centre Hospitalier Alpes Leman
  - Dunkerque, France, 59240
    - Institut Andrée Dutreix
  - Epagny Metz-Tessy, France, 74370
    - Centre Hospitalier Annecy Genevois
  - Evreux cedex, France, 27015
    - Centre Hospitalier Eure-Seine - Hopitaux d'Evreux - Vernon
  - Lyon, France, 69009
    - Clinique de la Sauvegarde
  - Marseilli, France, 13009
    - Hôpital Privé Clairval
  - St Quentin Cedex, France, 2321
    - Ch De St Quentin
  - VANNES Cedex, France, 56017
    - Ch Bretagne Atlantique de Vannes
  - Valence, France, 26000
    - Hopital Prive Drome Ardeche
Germany
- - Frankfurt, Germany, 60431
    - Markus Krankenhaus Frankfurt
  - Gronau, Germany, 48599
    - Prostata zentrum Nordwest
  - Herne, Germany, 44625
    - Marien Hospital Herne
  - Nuernberg, Germany, 90491
    - MVZ Urologie 24 gGmbH
  - Riesa, Germany, 1589
    - Elblandklinikum Riesa
  - Singen, Germany, 78224
    - Hegau Klinikum Singen
  - Wolfsburg, Germany, 38440
    - Urologischen Praxisgemeinschaft
Israel
- - Afula, Israel, 1834111
    - Haemek Medical Center - Afula
  - Haifa, Israel, 3436212
    - Carmel Medical Center
Italy
- - Camposampiero, Italy, 35012
    - Azienda Ulss 6 Euganea- Ospedale Di Camposampiero
  - Carrara, Italy, 54033
    - Ospedale Di Carrara
  - Cefalu, Italy, 90015
    - Fondazione Istituto G. Giglio
  - Chieti, Italy, 66100
    - Hospital SS Annunziata - University G.D'Annunzio
  - Città di Castello, Italy, 06012
    - Ospedale Città di Castello
  - Lido Di Camaiore, Italy
    - Az. USL 12 di Viareggio Ospedale Versilia
  - Lucca, Italy, 55100
    - Ospedale San Luca
  - Mantova, Italy, 46100
    - Azienda Ospedaliera Carlo Poma
  - Milano, Italy, 20153
    - Azienda Ospedaliera Ospedale San Carlo Borromeo
  - Mirano (VE), Italy, 30035
    - Ospedale Civile Di Mirano
  - Napoli, Italy, 80131
    - Azienda Ospedaliera 'A. Cardarelli'
  - Palermo, Italy, 90146
    - Casa di Cura La Maddalena
  - Palermo, Italy, 90123
    - Ospedale Buccheri La Ferla Fatebenefratelli
  - Palermo, Italy, 90146
    - A.O.R Villa Sofia Cervello
  - Ponte San Pietro, Italy, 24100
    - Policlinico San Pietro
  - Prato, Italy, 59100
    - Nuovo Ospedale di Prato - S. Stefano
  - Rho, Italy, 20017
    - ASST Rhodense - Ospedale di Rho
  - Rieti, Italy, 20100
    - Polo Ospedaliero Unico Integrato- Presidio S.Camillo De Lellis Di Rieti
  - Roma, Italy, 00144
    - Istituto Nazionale Tumori Regina Elena
  - Saronno, Italy, 21047
    - Ospedale Generale Provinciale - Saronno
  - Seriate, Italy, 24020
    - Ospedale Bolognini
  - Treviglio, Italy, 24047
    - Ospedale Treviglio-Caravaggio
  - Verduno (CN), Italy, 12060
    - SC Oncologia ASL CN2
  - Vicenza, Italy, 36100
    - Azienda Ulss 8 Berica- Ospedale Di Vicenza
  - Vimercate, Italy, 20087
    - Azienda Ospedaliera "Ospedale Civile" di Vimercate - Ospedal
Japan
- - Chiba, Japan, 277 -8567
    - The Jikei University Kashiwa Hospital
  - Chiba, Japan, 279-0021
    - Juntendo University Hospital Urayasu
  - Higashiibaraki-gun, Japan, 311-3193
    - National Hospital Organization Mito Medical Center
  - Hokkaido, Japan, 006-8555
    - Teine Keijinkai Hospital
  - Ibaraki, Japan, 3120057
    - Hitachinaka General Hospital
  - Ikeda, Japan, 563-8510
    - Ikeda City Hospital
  - Ise, Japan, 516-8512
    - Japanese Red Cross Ise Hospital
  - Isesaki, Japan, 372-0817
    - Isesaki Municipal Hospital
  - Kaizuka, Japan, 597-0015
    - Kaizuka City Hospital
  - Kanagawa, Japan, 241-8515
    - Kanagawa Cancer Center
  - Kanonji, Japan, 769-1695
    - Mitoyo General Hospital
  - Kawachi-Nagano, Japan, 586-8521
    - National Hospital Organization Osaka Minami Medical Center
  - Kiryu, Japan, 376-0024
    - Kiryu Kosei General Hospital
  - Kisarazu-shi, Japan, 292-8535
    - Kimitsu Chuo Hospital
  - Kitaadachi-gun, Japan, 362-0806
    - Saitama Cancer Center
  - Kitamoto, Japan, 364-8501
    - Kitasato University Medical Center
  - Koshigaya, Japan, 343-8555
    - Dokkyo Medical University Saitama Medical Center
  - Minato-ku, Japan, 108-8642
    - Kitasato University Kitasato Institute Hospital
  - Mito, Japan, 310-0011
    - Japanese Red Cross Mito Hospital
  - Narita, Japan, 286-8523
    - Japanese Red Cross Narita Hospital
  - Nerima-Ku, Japan, 177-8521
    - Juntendo University Nerima Hospital
  - Nishi-Ku, Japan, 651-2273
    - Kobe City Nishi-Kobe Medical Center
  - Osaka, Japan, 540-0006
    - National Hospital Organization Osaka National Hospital
  - Osaka, Japan, 558-8558
    - Osaka General Medical Center
  - Osaka, Japan, 543-0035
    - Osaka Police Hospital
  - Osaka, Japan, 540-0008
    - Otemae Hospital
  - Osaka, Japan, 591-8025
    - JOHAS Osaka Rosai Hospital
  - Ota, Japan, 373-8585
    - SUBARU Health Insurance Society Ota Memorial Hospital
  - Sagamihara, Japan, 252-0392
    - National Hospital Organization Sagamihara National Hospital
  - Sakai City, Japan, 593-8304
    - Sakai City Medical Center
  - Sapporo, Japan, 005-0002
    - Jinyukai Hospital
  - Tokyo, Japan, 113-8677
    - Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
  - Tokyo, Japan, 101-8643
    - Mitsui Memorial Hospital
  - Tsuchiura-City, Japan, 300-0028
    - Tsuchiura Kyodo General Hospital
  - Tsukuba-City, Japan, 305-8558
    - Tsukuba Medical Center Hospital
Russian Federation
- - Anzorey, Russian Federation, 361336
    - State Budgetary Healthcare Institution Inter-regional Multi-specialty Hospital
  - Chelyabinsk, Russian Federation, 454048
    - LLC Evimed
  - Ekaterinburg, Russian Federation, 620102
    - SHI Sverdlovsk Regional Clinical Hospital #1
  - Moscow, Russian Federation, 17997
    - FSBI A.V. Vishnevsky National Medical Research Center of Surgery of the MoH RF
  - Saint-Petersburg, Russian Federation, 194354
    - LLC 1 named after Berezin Sergey
  - St-Petersburg, Russian Federation, 196006
    - Oncology Medical Clinics AV Medical group
  - Syktivkar, Russian Federation, 167094
    - Komi Republican Oncology Dispensary
  - Tomsk, Russian Federation, 634009
    - Tomsk National Research Medical Center of the Russian Academy of Sciences
  - Yaroslavl, Russian Federation, 150054
    - Yaroslavl Regional Clinical Oncology Hospital
Spain
- - Alcorcón, Spain, 28922
    - Hosp. Univ. Fundacion Alcorcon
  - Barcelona, Spain, 08400
    - Hosp. Gral. de Granollers
  - Cadiz, Spain, 11009
    - Hosp. Puerta Del Mar
  - Donosti, Spain, 20080
    - Hosp. Univ. Donostia
  - Jerez de la Frontera, Spain, 11407
    - Genesiscare Jerez de La Frontera
  - Madrid, Spain, 28006
    - Hosp. Univ. de La Princesa
  - Madrid, Spain, 28822
    - Hosp. Univ. Del Henares
  - Oviedo, Spain, 33011
    - Hosp. Univ. Central de Asturias
  - San Sebastián De Los Reyes, Spain, 28702
    - Hosp. Univ. Infanta Sofia
  - Sevilla, Spain, 41013
    - Hosp. Quiron Sagrado Corazon
  - Terrassa, Spain, 08227
    - Hosp. de Terrassa
  - Toledo, Spain, 45004
    - Hosp. Virgen de La Salud
Turkey
- - Adana, Turkey, 1130
    - Adana Acibadem Hospital
  - Ankara, Turkey, 6200
    - Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
  - Aydin, Turkey, 09100
    - Adnan Menderes University Training and Research Hospital
  - Canakkale, Turkey, 17110
    - Canakkale Onsekiz Mart University Health Practices and Research Hospital
  - Istanbul, Turkey, 34668
    - Haydarpasa Numune Training and Research Hospital
  - Istanbul, Turkey, 34371
    - Sisli Etfal Research Training Hospital
  - Istanbul, Turkey, 34890
    - Kartal Dr. Lutfi Kirdar Egitim ve Arastirma Hastanesi
  - Izmir, Turkey, 35575
    - Izmir Medical Park Hospital
  - Izmir, Turkey, 35360
    - Izmir Katip Celebi University Ataturk Training and Research Hospital
  - Kocaeli, Turkey, 41900
    - Derince Egitim ve Arastirma Hastanesi
  - Konya, Turkey, 42080
    - Necmettin Erbakan University Meram Medical Faculty
  - Manisa, Turkey, 45030
    - Manisa Celal Bayar University
  - Samsun, Turkey, 55200
    - Medical Park Samsun Hastanesi
  - Samsun, Turkey, 55200
    - Ondokuz Mayis University
Ukraine
- - Chernivtsi, Ukraine, 58013
    - Municipal Non-profit enterprise 'Bukovinian clinical oncology center'
  - Kamianske, Ukraine, 51900
    - Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council
  - Kharkiv, Ukraine, 61037
    - Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval
  - Khmelnytsky, Ukraine, 29000
    - Khmelnitckiy regional hospital
  - Kropyvnytskyi, Ukraine, 25011
    - Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council'
  - Kyiv, Ukraine, 03115
    - State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
  - Lviv, Ukraine, 79031
    - Lviv Clinical Regional Hospital
  - Poltava, Ukraine, 36024
    - ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'
  - Uzhgorod, Ukraine, 88000
    - Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
  - Zaporizhzhia, Ukraine, 69076
    - Medical Center 'Diaservis'
  - Zhytomyr, Ukraine, 10002
    - Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council
United Kingdom
- - Colchester, United Kingdom, CO4 5JL
    - Colchester Hospital University NHS
  - Exeter, United Kingdom, EX2 5DW
    - Royal Devon & Exeter Hospital
  - Portsmouth, United Kingdom, PO6 3LY
    - Queen Alexandra Hospital
  - Preston, United Kingdom, PR2 9HT
    - Royal Preston Hospital
  - Wirral, United Kingdom, CH63 4JY
    - The Clatterbridge Cancer Centre
United States
- Arizona
  - Tucson, Arizona, United States, 85711
    - Arizona Oncology Associates, PC - HOPE
- Colorado
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers
- Delaware
  - Newark, Delaware, United States, 19713
    - Medical Oncology Hematology Consultants, PA
- Illinois
  - Chicago Ridge, Illinois, United States, 60415
    - Affiliated Oncologists, LLC
- Maryland
  - Brandywine, Maryland, United States, 20613
    - Maryland Oncology Hematology, PA
- Minnesota
  - Minneapolis, Minnesota, United States, 55404
    - Minnesota Oncology Hematology, P.A.
- New York
  - Albany, New York, United States, 12206
    - New York Oncology Hematology
  - Johnson City, New York, United States, 13790
    - Broome Oncology
- Ohio
  - Cincinnati, Ohio, United States, 45242
    - Oncology Hematology Care
- Oregon
  - Eugene, Oregon, United States, 97401
    - Willamette Valley Cancer Institute and Research Center
  - Tualatin, Oregon, United States, 97062
    - Northwest Cancer Specialists PC
- Pennsylvania
  - Horsham, Pennsylvania, United States, 19044
    - Consultants in Medical Oncology and Hematology, P.C. - Abington
- Texas
  - Dallas, Texas, United States, 75246
    - Texas Oncology-Baylor Charles A. Sammons Cancer Center
  - Denton, Texas, United States, 76210
    - Texas Oncology-Denton South
  - Flower Mound, Texas, United States, 75028
    - Texas Oncology, P.A. - Flower Mound
  - Fort Worth, Texas, United States, 76104
    - Texas Oncology-Fort Worth Cancer Center
  - Houston, Texas, United States, 77024
    - Texas Oncology-Memorial City
  - Midland, Texas, United States, 79701
    - Texas Oncology-Midland Allison Cancer Center
  - San Antonio, Texas, United States, 78217
    - University of Texas at San Antonio
  - Sherman, Texas, United States, 75090
    - Texas Oncology-Sherman
  - Tyler, Texas, United States, 75702
    - Texas Oncology-Tyler
  - Waco, Texas, United States, 76712
    - Texas Oncology -Waco
- Virginia
  - Norfolk, Virginia, United States, 23502
    - Virginia Oncology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort Group / Cohort A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.	Intervention / Treatment Intervention / Treatment A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.	Other: Archival Tumor Tissue Sample Percentage of participants with UC and selected FGFR aberrations will be assessed through molecular testing of their archival tumor tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations Time Frame: Up to 3.9 years	Percentage of participants with selected FGFR gene aberrations will be assessed through molecular testing of their archival tumor tissue.	Up to 3.9 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

September 19, 2022

Study Completion (Actual)

September 19, 2022

Study Registration Dates

First Submitted

May 17, 2019

First Submitted That Met QC Criteria

May 17, 2019

First Posted (Actual)

May 20, 2019

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

CR108627
42756493BLC0002 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated device product