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

Completed

• Conditions: Urothelial Cancer; Receptors, Fibroblast Growth Factor
• Interventions: Other: Archival Tumor Tissue Sample

• Registration Number: NCT03955913
• Lead Sponsor: Janssen Research & Development, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-20
• Study Start: 2019-08-01
• Primary Completion: 2022-09-19
• Study Completion: 2022-09-19
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3679

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with Urothelial Cancer,selected FGFR aberrations	Archival Tumor Tissue Sample	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.

Primary Outcome Measures

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

Trial Locations

Locations (199)

Arizona Oncology Associates, PC - HOPE; 🇺🇸 Tucson, Arizona, United States

Rocky Mountain Cancer Centers; 🇺🇸 Denver, Colorado, United States

Hospital Privado de Cordoba; 🇦🇷 Cordoba, Argentina

Ynova Pesquisa Clinica; 🇧🇷 Florianopolis, Brazil

Maryland Oncology Hematology, PA; 🇺🇸 Brandywine, Maryland, United States

Willamette Valley Cancer Institute and Research Center; 🇺🇸 Eugene, Oregon, United States

Jolimont; 🇧🇪 Haine-Saint-Paul, La Louviere, Belgium

SCMI Santa Casa de Misericórdia de Itabuna; 🇧🇷 Itabuna, Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre; 🇧🇷 Porto Alegre, Brazil

ZNA Jan Palfijn; 🇧🇪 Merksem, Belgium

CHU UCL Namur - Site Sainte Elisabeth; 🇧🇪 Namur, Belgium

Nucleo de Ensino e Pesquisa do Instituto Mario Penna; 🇧🇷 Belo Horizonte, Brazil

Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge; 🇧🇷 Goiania, Brazil

Instituto Do Cancer Do Hospital Pompeia; 🇧🇷 Caxias Do Sul, Brazil

Cepeville - Centro de Hematologia e Oncologia; 🇧🇷 Joinville, Brazil

Azienda Ulss 6 Euganea- Ospedale Di Camposampiero; 🇮🇹 Camposampiero, Italy

Fondazione Istituto G. Giglio; 🇮🇹 Cefalu, Italy

Ospedale Città Di Castello; 🇮🇹 Città di Castello, Italy

Azienda Ospedaliera 'A. Cardarelli'; 🇮🇹 Napoli, Italy

Nuovo Ospedale Di Prato - S. Stefano; 🇮🇹 Prato, Italy

Asst Rhodense - Ospedale Di Rho; 🇮🇹 Rho, Italy

Ospedale Generale Provinciale - Saronno; 🇮🇹 Saronno, Italy

SC Oncologia ASL CN2; 🇮🇹 Verduno (CN), Italy

Azienda Ulss 8 Berica- Ospedale Di Vicenza; 🇮🇹 Vicenza, Italy

Azienda Ospedaliera "Ospedale Civile" di Vimercate - Ospedal; 🇮🇹 Vimercate, Italy

Ikeda City Hospital; 🇯🇵 Ikeda, Japan

Japanese Red Cross Ise Hospital; 🇯🇵 Ise, Japan

Mitoyo General Hospital; 🇯🇵 Kanonji, Japan

Kiryu Kosei General Hospital; 🇯🇵 Kiryu, Japan

Kimitsu Chuo Hospital; 🇯🇵 Kisarazu-shi, Japan

Saitama Cancer center; 🇯🇵 Kitaadachi-gun, Japan

Dokkyo Medical University Saitama Medical Center; 🇯🇵 Koshigaya, Japan

Japanese Red Cross Mito Hospital; 🇯🇵 Mito, Japan

Juntendo University Nerima Hospital; 🇯🇵 Nerima-Ku, Japan

Otemae Hospital; 🇯🇵 Osaka, Japan

Tsukuba Medical Center Hospital; 🇯🇵 Tsukuba-City, Japan

LLC 1 named after Berezin Sergey; 🇷🇺 Saint-Petersburg, Russian Federation

Komi Republican Oncology Dispensary; 🇷🇺 Syktivkar, Russian Federation

Yaroslavl Regional Clinical Oncology Hospital; 🇷🇺 Yaroslavl, Russian Federation

Adana Acibadem Hospital; 🇹🇷 Adana, Turkey

Izmir Medical Park Hospital; 🇹🇷 Izmir, Turkey

Ondokuz Mayis University; 🇹🇷 Samsun, Turkey

Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital; 🇹🇷 Ankara, Turkey

Adnan Menderes University Training and Research Hospital; 🇹🇷 Aydin, Turkey

Kartal Dr. Lutfi Kirdar Egitim ve Arastirma Hastanesi; 🇹🇷 Istanbul, Turkey

Canakkale Onsekiz Mart University Health Practices and Research Hospital; 🇹🇷 Canakkale, Turkey

Şişli Etfal Research Training Hospital; 🇹🇷 Istanbul, Turkey

Haydarpasa Numune Training and Research Hospital; 🇹🇷 Istanbul, Turkey

Derince Egitim ve Arastirma Hastanesi; 🇹🇷 Kocaeli, Turkey

State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center; 🇺🇦 Kyiv, Ukraine

Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council; 🇺🇦 Kamianske, Ukraine

Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal; 🇺🇦 Uzhgorod, Ukraine

Manisa Celal Bayar University; 🇹🇷 Manisa, Turkey

Medical Park Samsun Hastanesi; 🇹🇷 Samsun, Turkey

Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval; 🇺🇦 Kharkiv, Ukraine

Khmelnitckiy regional hospital; 🇺🇦 Khmelnytsky, Ukraine

Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council; 🇺🇦 Zhytomyr, Ukraine

Lviv Clinical Regional Hospital; 🇺🇦 Lviv, Ukraine

ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'; 🇺🇦 Poltava, Ukraine

Medical Center 'Diaservis'; 🇺🇦 Zaporizhzhia, Ukraine

IRPCC - Instituto Ribeiraopretano de Combate ao Cancer; 🇧🇷 Ribeirao Preto, Brazil

Hospital SS Annunziata - University G.D'Annunzio; 🇮🇹 Chieti, Italy

Queen Alexandra Hospital; 🇬🇧 Portsmouth, United Kingdom

New York Oncology Hematology; 🇺🇸 Albany, New York, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center; 🇺🇸 Dallas, Texas, United States

Texas Oncology-Midland Allison Cancer Center; 🇺🇸 Midland, Texas, United States

Texas Oncology-Sherman; 🇺🇸 Sherman, Texas, United States

Texas Oncology-Tyler; 🇺🇸 Tyler, Texas, United States

Colchester Hospital University NHS; 🇬🇧 Colchester, United Kingdom

Clinica de Oncologia Reichow; 🇧🇷 Blumenau, Brazil

CH Chambéry; 🇫🇷 Chambery, France

Hôpital Privé Clairval; 🇫🇷 Marseilli, France

Prostata zentrum Nordwest; 🇩🇪 Gronau, Germany

Hegau Klinikum Singen; 🇩🇪 Singen, Germany

Ospedale San Luca; 🇮🇹 Lucca, Italy

Ospedale Civile di Mirano; 🇮🇹 Mirano (VE), Italy

Ospedale Bolognini; 🇮🇹 Seriate, Italy

Juntendo University Hospital Urayasu; 🇯🇵 Chiba, Japan

Kaizuka City Hospital; 🇯🇵 Kaizuka, Japan

Japanese Red Cross Narita Hospital; 🇯🇵 Narita, Japan

Hosp. Univ. Donostia; 🇪🇸 Donosti, Spain

Royal Preston Hospital; 🇬🇧 Preston, United Kingdom

Medical Oncology Hematology Consultants, PA; 🇺🇸 Newark, Delaware, United States

University of Texas at San Antonio; 🇺🇸 San Antonio, Texas, United States

Sanatorio Allende Cerro; 🇦🇷 Cordoba, Argentina

Northwest Cancer Specialists PC; 🇺🇸 Tualatin, Oregon, United States

Sanatorio Mayo SA; 🇦🇷 Santa Fe, Argentina

Fundacao Doutor Amaral Carvalho; 🇧🇷 Jau, Brazil

Núcleo de Oncologia da Bahia; 🇧🇷 Salvador, Brazil

Broome Oncology; 🇺🇸 Johnson City, New York, United States

Texas Oncology-Denton South; 🇺🇸 Denton, Texas, United States

Clinique Saint Pierre; 🇧🇪 Ottignies, Belgium

NAIC - Nair Antunes Instituto do Câncer; 🇧🇷 Bauru, Brazil

Santa Casa de Misericordia de Belo Horizonte; 🇧🇷 Belo Horizonte, Brazil

Minnesota Oncology Hematology, P.A.; 🇺🇸 Minneapolis, Minnesota, United States

Texas Oncology-Memorial City; 🇺🇸 Houston, Texas, United States

Affiliated Oncologists, LLC; 🇺🇸 Chicago Ridge, Illinois, United States

Consultants in Medical Oncology and Hematology, P.C. - Abington; 🇺🇸 Horsham, Pennsylvania, United States

Ensino e Terapia de Inovacao Clinica AMO - Etica; 🇧🇷 Salvador, Brazil

Hospital Paulistano; 🇧🇷 São Paulo, Brazil

Instituto do Cancer De Tres Lagoas; 🇧🇷 Três Lagoas, Brazil

Hosp. Univ. Central de Asturias; 🇪🇸 Oviedo, Spain

Hosp. Gral. de Granollers; 🇪🇸 Barcelona, Spain

National Hospital Organization Osaka Minami Medical Center; 🇯🇵 Kawachi-Nagano, Japan

Kobe City Nishi-Kobe Medical Center; 🇯🇵 Nishi-Ku, Japan

Royal Devon & Exeter Hospital; 🇬🇧 Exeter, United Kingdom

Hosp. Univ. Fundacion Alcorcon; 🇪🇸 Alcorcón, Spain

Genesiscare Jerez de La Frontera; 🇪🇸 Jerez de la Frontera, Spain

Hosp. Puerta Del Mar; 🇪🇸 Cadiz, Spain

Hosp. Univ. de La Princesa; 🇪🇸 Madrid, Spain

Jinyukai Hospital; 🇯🇵 Sapporo, Japan

Municipal Non-profit enterprise 'Bukovinian clinical oncology center'; 🇺🇦 Chernivtsi, Ukraine

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital; 🇯🇵 Tokyo, Japan

LLC Evimed; 🇷🇺 Chelyabinsk, Russian Federation

The Clatterbridge Cancer Centre; 🇬🇧 Wirral, United Kingdom

Hosp. Univ. Del Henares; 🇪🇸 Madrid, Spain

Hosp. Univ. Infanta Sofia; 🇪🇸 San Sebastián De Los Reyes, Spain

Hosp. de Terrassa; 🇪🇸 Terrassa, Spain

CIPREC; 🇦🇷 Buenos Aires, Argentina

Oncology Hematology Care; 🇺🇸 Cincinnati, Ohio, United States

Texas Oncology, P.A. - Flower Mound; 🇺🇸 Flower Mound, Texas, United States

Texas Oncology-Fort Worth Cancer Center; 🇺🇸 Fort Worth, Texas, United States

Texas Oncology -Waco; 🇺🇸 Waco, Texas, United States

Investigaciones Clinico Moleculares (ICM); 🇦🇷 Caba, Argentina

Virginia Oncology Associates; 🇺🇸 Norfolk, Virginia, United States

Instituto Médico de Río Cuarto; 🇦🇷 Cordoba, Argentina

FUCDIM - Centro Urológico Modelo; 🇦🇷 Córdoba, Argentina

Az Groeninge; 🇧🇪 Kortrijk, Belgium

Instituto Sensumed de Ensino e Pesquisa Ruy França - ISENP; 🇧🇷 Manaus, Brazil

CHU de Liège - Domaine Universitaire du Sart Tilman; 🇧🇪 Liege, Belgium

CHPLT Verviers; 🇧🇪 Verviers, Belgium

Universidade Estadual De Campinas; 🇧🇷 Campinas, Brazil

Instituto de Oncologia do Paraná; 🇧🇷 Curitiba, Brazil

Hospital do Cancer de Londrina; 🇧🇷 Londrina, Brazil

Hospital Ernesto Dornelles; 🇧🇷 Porto Alegre, Brazil

Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas; 🇧🇷 Sorocaba, Brazil

Centro de Pesquisa em Oncologia Onco SG; 🇧🇷 Santa Cruz Do Sul, Brazil

CEDOES - Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda.; 🇧🇷 Vitoria, Brazil

CHU Amiens Picardie; 🇫🇷 Amiens Cedex 1, France

Institut Sainte Catherine; 🇫🇷 Avignon Cedex 9, France

Associacao Feminina de Educacao e Combate ao Cancer - Hospital Santa Rita de Cassia; 🇧🇷 Vitoria, Brazil

Polyclinique du Parc Rambot; 🇫🇷 Aix En Provence, France

Centre Hospitalier de Boulogne-sur-Mer; 🇫🇷 Boulogne-sur-Mer Cédex, France

Centre Hospitalier Dr Jean-Eric TECHER; 🇫🇷 Calais, France

Centre Hospitalier Alpes Léman; 🇫🇷 Contamine-Sur-Arve, France

Hôpital Privé d'Anthony; 🇫🇷 Antony, France

Hôpital de Fleyriat; 🇫🇷 Bourg en Bresse, France

Hôpital Privé Drome Ardèche; 🇫🇷 Valence, France

Institut Andree DUTREIX; 🇫🇷 Dunkerque, France

Centre Hospitalier Annecy Genevois; 🇫🇷 Epagny Metz-Tessy, France

Centre Hospitalier Eure-Seine - Hopitaux d'Evreux - Vernon; 🇫🇷 Evreux cedex, France

Ch Bretagne Atlantique De Vannes; 🇫🇷 VANNES Cedex, France

Clinique de la Sauvegarde; 🇫🇷 Lyon, France

Ch De St Quentin; 🇫🇷 St Quentin Cedex, France

MVZ Urologie 24 gGmbH; 🇩🇪 Nuernberg, Germany

Carmel Medical Center; 🇮🇱 Haifa, Israel

Markus Krankenhaus Frankfurt; 🇩🇪 Frankfurt, Germany

Urologischen Praxisgemeinschaft; 🇩🇪 Wolfsburg, Germany

Marien hospital Herne; 🇩🇪 Herne, Germany

ELBLANDKLINIKUM Riesa; 🇩🇪 Riesa, Germany

Haemek Medical Center - Afula; 🇮🇱 Afula, Israel

Ospedale Di Carrara; 🇮🇹 Carrara, Italy

Az. USL 12 di Viareggio Ospedale Versilia; 🇮🇹 Lido Di Camaiore, Italy

Ospedale Buccheri La Ferla Fatebenefratelli; 🇮🇹 Palermo, Italy

Casa di Cura La Maddalena; 🇮🇹 Palermo, Italy

Policlinico San Pietro; 🇮🇹 Ponte San Pietro, Italy

Azienda Ospedaliera Carlo Poma; 🇮🇹 Mantova, Italy

Ospedale Treviglio-Caravaggio; 🇮🇹 Treviglio, Italy

Istituto Nazionale Tumori Regina Elena; 🇮🇹 Roma, Italy

Azienda Ospedaliera Ospedale San Carlo Borromeo; 🇮🇹 Milano, Italy

A.O.R Villa Sofia Cervello; 🇮🇹 Palermo, Italy

Polo Ospedaliero Unico Integrato- Presidio S.Camillo De Lellis Di Rieti; 🇮🇹 Rieti, Italy

Kanagawa Cancer Center; 🇯🇵 Kanagawa, Japan

The Jikei University Kashiwa Hospital; 🇯🇵 Chiba, Japan

National Hospital Organization Mito Medical Center; 🇯🇵 Higashiibaraki-gun, Japan

Teine Keijinkai Hospital; 🇯🇵 Hokkaido, Japan

Kitasato University Medical Center; 🇯🇵 Kitamoto, Japan

Isesaki Municipal Hospital; 🇯🇵 Isesaki, Japan

Hitachinaka General Hospital; 🇯🇵 Ibaraki, Japan

Kitasato University Kitasato Institute Hospital; 🇯🇵 Minato-ku, Japan

Osaka General Medical Center; 🇯🇵 Osaka, Japan

National Hospital Organization Osaka National Hospital; 🇯🇵 Osaka, Japan

Osaka Police Hospital; 🇯🇵 Osaka, Japan

JOHAS Osaka Rosai Hospital; 🇯🇵 Osaka, Japan

SUBARU Health Insurance Society Ota Memorial Hospital; 🇯🇵 Ota, Japan

National Hospital Organization Sagamihara National Hospital; 🇯🇵 Sagamihara, Japan

Sakai City Medical Center; 🇯🇵 Sakai City, Japan

Tsuchiura Kyodo General Hospital; 🇯🇵 Tsuchiura-City, Japan

State Budgetary Healthcare Institution Inter-regional Multi-specialty Hospital; 🇷🇺 Anzorey, Russian Federation

SHI Sverdlovsk Regional Clinical Hospital #1; 🇷🇺 Ekaterinburg, Russian Federation

Mitsui Memorial Hospital; 🇯🇵 Tokyo, Japan

Tomsk National Research Medical Center of the Russian Academy of Sciences; 🇷🇺 Tomsk, Russian Federation

FSBI A.V. Vishnevsky National Medical Research Center of Surgery of the MoH RF; 🇷🇺 Moscow, Russian Federation

Oncology Medical Clinics AV Medical group; 🇷🇺 St-Petersburg, Russian Federation

Hosp. Quiron Sagrado Corazon; 🇪🇸 Sevilla, Spain

Hosp. Virgen de La Salud; 🇪🇸 Toledo, Spain

Izmir Katip Celebi University Ataturk Training and Research Hospital; 🇹🇷 Izmir, Turkey

Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council'; 🇺🇦 Kropyvnytskyi, Ukraine

Necmettin Erbakan University Meram Medical Faculty; 🇹🇷 Konya, Turkey