A Study to Identify Participants With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations
- Conditions
- Urothelial CancerReceptors, 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3679
- 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
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.
- Secondary Outcome Measures
Name Time Method
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