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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03955913
Other study ID # CR108627
Secondary ID 42756493BLC0002
Status Completed
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date September 19, 2022

Study information

Verified date February 2023
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 3679
Est. completion date September 19, 2022
Est. primary completion date September 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Argentina CIPREC Buenos Aires
Argentina Investigaciones Clinico Moleculares (ICM) Caba
Argentina Hospital Privado de Cordoba Cordoba
Argentina Instituto Médico de Río Cuarto Cordoba
Argentina Sanatorio Allende Cerro Cordoba
Argentina FUCDIM - Centro Urológico Modelo Córdoba
Argentina Sanatorio Mayo SA Santa Fe
Belgium Jolimont Haine-Saint-Paul, La Louviere
Belgium Az Groeninge Kortrijk
Belgium CHU de Liège - Domaine Universitaire du Sart Tilman Liege
Belgium ZNA Jan Palfijn Merksem
Belgium CHU UCL Namur - Site Sainte Elisabeth Namur
Belgium Clinique Saint Pierre Ottignies
Belgium CHPLT Verviers Verviers
Brazil NAIC - Nair Antunes Instituto do Câncer Bauru
Brazil Nucleo de Ensino e Pesquisa do Instituto Mario Penna Belo Horizonte
Brazil Santa Casa de Misericordia de Belo Horizonte Belo Horizonte
Brazil Clinica de Oncologia Reichow Blumenau
Brazil Universidade Estadual De Campinas Campinas
Brazil Instituto Do Cancer Do Hospital Pompeia Caxias Do Sul
Brazil Instituto de Oncologia do Paraná Curitiba
Brazil Ynova Pesquisa Clinica Florianopolis
Brazil Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge Goiania
Brazil SCMI Santa Casa de Misericórdia de Itabuna Itabuna
Brazil Fundacao Doutor Amaral Carvalho Jau
Brazil Cepeville - Centro de Hematologia e Oncologia Joinville
Brazil Hospital do Cancer de Londrina Londrina
Brazil Instituto Sensumed de Ensino e Pesquisa Ruy França - ISENP Manaus
Brazil Hospital Ernesto Dornelles Porto Alegre
Brazil Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre
Brazil IRPCC - Instituto Ribeiraopretano de Combate ao Cancer Ribeirao Preto
Brazil Ensino e Terapia de Inovacao Clinica AMO - Etica Salvador
Brazil Núcleo de Oncologia da Bahia Salvador
Brazil Centro de Pesquisa em Oncologia Onco SG Santa Cruz Do Sul
Brazil Hospital Paulistano São Paulo
Brazil Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas Sorocaba
Brazil Instituto do Cancer De Tres Lagoas Três Lagoas
Brazil Associacao Feminina de Educacao e Combate ao Cancer - Hospital Santa Rita de Cassia Vitoria
Brazil CEDOES - Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda. Vitoria
France Polyclinique du Parc Rambot Aix En Provence
France CHU Amiens Picardie Amiens Cedex 1
France Hôpital Privé d'Anthony Antony
France Institut Sainte Catherine Avignon Cedex 9
France Centre Hospitalier de Boulogne-sur-Mer Boulogne-sur-Mer Cédex
France Hôpital de Fleyriat Bourg en Bresse
France Centre Hospitalier Dr Jean-Eric TECHER Calais
France CH Chambéry Chambery
France Centre Hospitalier Alpes Léman Contamine-Sur-Arve
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 Clinique de la Sauvegarde Lyon
France Hôpital Privé Clairval Marseilli
France Ch De St Quentin St Quentin Cedex
France Hôpital Privé Drome Ardèche Valence
France Ch Bretagne Atlantique De Vannes VANNES Cedex
Germany Markus Krankenhaus Frankfurt Frankfurt
Germany Prostata zentrum Nordwest Gronau
Germany Marien hospital Herne Herne
Germany MVZ Urologie 24 gGmbH Nuernberg
Germany ELBLANDKLINIKUM Riesa Riesa
Germany Hegau Klinikum Singen Singen
Germany Urologischen Praxisgemeinschaft Wolfsburg
Israel Haemek Medical Center - Afula Afula
Israel Carmel Medical Center Haifa
Italy Azienda Ulss 6 Euganea- Ospedale Di Camposampiero Camposampiero
Italy Ospedale Di Carrara Carrara
Italy Fondazione Istituto G. Giglio Cefalu
Italy Hospital SS Annunziata - University G.D'Annunzio Chieti
Italy Ospedale Città Di Castello Città di Castello
Italy Az. USL 12 di Viareggio Ospedale Versilia Lido Di Camaiore
Italy Ospedale San Luca Lucca
Italy Azienda Ospedaliera Carlo Poma Mantova
Italy Azienda Ospedaliera Ospedale San Carlo Borromeo Milano
Italy Ospedale Civile di Mirano Mirano (VE)
Italy Azienda Ospedaliera 'A. Cardarelli' Napoli
Italy A.O.R Villa Sofia Cervello Palermo
Italy Casa di Cura La Maddalena Palermo
Italy Ospedale Buccheri La Ferla Fatebenefratelli Palermo
Italy Policlinico San Pietro Ponte San Pietro
Italy Nuovo Ospedale Di Prato - S. Stefano Prato
Italy Asst Rhodense - Ospedale Di Rho Rho
Italy Polo Ospedaliero Unico Integrato- Presidio S.Camillo De Lellis Di Rieti Rieti
Italy Istituto Nazionale Tumori Regina Elena Roma
Italy Ospedale Generale Provinciale - Saronno Saronno
Italy Ospedale Bolognini Seriate
Italy Ospedale Treviglio-Caravaggio Treviglio
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
Japan Juntendo University Hospital Urayasu Chiba
Japan The Jikei University Kashiwa Hospital Chiba
Japan National Hospital Organization Mito Medical Center Higashiibaraki-gun
Japan Teine Keijinkai Hospital Hokkaido
Japan Hitachinaka General Hospital Ibaraki
Japan Ikeda City Hospital Ikeda
Japan Japanese Red Cross Ise Hospital Ise
Japan Isesaki Municipal Hospital Isesaki
Japan Kaizuka City Hospital Kaizuka
Japan Kanagawa Cancer Center Kanagawa
Japan Mitoyo General Hospital Kanonji
Japan National Hospital Organization Osaka Minami Medical Center Kawachi-Nagano
Japan Kiryu Kosei General Hospital Kiryu
Japan Kimitsu Chuo Hospital Kisarazu-shi
Japan Saitama Cancer center Kitaadachi-gun
Japan Kitasato University Medical Center Kitamoto
Japan Dokkyo Medical University Saitama Medical Center Koshigaya
Japan Kitasato University Kitasato Institute Hospital Minato-ku
Japan Japanese Red Cross Mito Hospital Mito
Japan Japanese Red Cross Narita Hospital Narita
Japan Juntendo University Nerima Hospital Nerima-Ku
Japan Kobe City Nishi-Kobe Medical Center Nishi-Ku
Japan JOHAS Osaka Rosai Hospital Osaka
Japan National Hospital Organization Osaka National Hospital Osaka
Japan Osaka General Medical Center Osaka
Japan Osaka Police Hospital Osaka
Japan Otemae 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 Jinyukai Hospital Sapporo
Japan Mitsui Memorial Hospital Tokyo
Japan Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Tokyo
Japan Tsuchiura Kyodo General Hospital Tsuchiura-City
Japan Tsukuba Medical Center Hospital Tsukuba-City
Russian Federation State Budgetary Healthcare Institution Inter-regional Multi-specialty Hospital Anzorey
Russian Federation LLC Evimed Chelyabinsk
Russian Federation SHI Sverdlovsk Regional Clinical Hospital #1 Ekaterinburg
Russian Federation FSBI A.V. Vishnevsky National Medical Research Center of Surgery of the MoH RF Moscow
Russian Federation LLC 1 named after Berezin Sergey Saint-Petersburg
Russian Federation Oncology Medical Clinics AV Medical group St-Petersburg
Russian Federation Komi Republican Oncology Dispensary Syktivkar
Russian Federation Tomsk National Research Medical Center of the Russian Academy of Sciences Tomsk
Russian Federation Yaroslavl Regional Clinical Oncology Hospital Yaroslavl
Spain Hosp. Univ. Fundacion Alcorcon Alcorcón
Spain Hosp. Gral. de Granollers Barcelona
Spain Hosp. Puerta Del Mar Cadiz
Spain Hosp. Univ. Donostia Donosti
Spain Genesiscare Jerez de La Frontera Jerez de la Frontera
Spain Hosp. Univ. de La Princesa Madrid
Spain Hosp. Univ. Del Henares Madrid
Spain Hosp. Univ. Central de Asturias Oviedo
Spain Hosp. Univ. Infanta Sofia San Sebastián De Los Reyes
Spain Hosp. Quiron Sagrado Corazon Sevilla
Spain Hosp. de Terrassa Terrassa
Spain Hosp. Virgen de La Salud Toledo
Turkey Adana Acibadem Hospital Adana
Turkey Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital Ankara
Turkey Adnan Menderes University Training and Research Hospital Aydin
Turkey Canakkale Onsekiz Mart University Health Practices and Research Hospital Canakkale
Turkey Haydarpasa Numune Training and Research Hospital Istanbul
Turkey Kartal Dr. Lutfi Kirdar Egitim ve Arastirma Hastanesi Istanbul
Turkey Sisli Etfal Research Training Hospital Istanbul
Turkey Izmir Katip Celebi University Ataturk Training and Research Hospital Izmir
Turkey Izmir Medical Park Hospital Izmir
Turkey Derince Egitim ve Arastirma Hastanesi Kocaeli
Turkey Necmettin Erbakan University Meram Medical Faculty Konya
Turkey Manisa Celal Bayar University Manisa
Turkey Medical Park Samsun Hastanesi Samsun
Turkey Ondokuz Mayis University Samsun
Ukraine Municipal Non-profit enterprise 'Bukovinian clinical oncology center' Chernivtsi
Ukraine Communal Institution 'City hospital ?7 of Kamianske' of Dnepropetrov'sk Regional Council Kamianske
Ukraine Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval Kharkiv
Ukraine Khmelnitckiy regional hospital Khmelnytsky
Ukraine Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council' Kropyvnytskyi
Ukraine State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center Kyiv
Ukraine Lviv Clinical Regional Hospital Lviv
Ukraine ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council' Poltava
Ukraine Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal Uzhgorod
Ukraine Medical Center 'Diaservis' Zaporizhzhia
Ukraine Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council Zhytomyr
United Kingdom Colchester Hospital University NHS Colchester
United Kingdom Royal Devon & Exeter Hospital Exeter
United Kingdom Queen Alexandra Hospital Portsmouth
United Kingdom Royal Preston Hospital Preston
United Kingdom The Clatterbridge Cancer Centre Wirral
United States New York Oncology Hematology Albany New York
United States Maryland Oncology Hematology, PA Brandywine Maryland
United States Affiliated Oncologists, LLC Chicago Ridge Illinois
United States Oncology Hematology Care Cincinnati Ohio
United States Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas
United States Texas Oncology-Denton South Denton Texas
United States Rocky Mountain Cancer Centers Denver Colorado
United States Willamette Valley Cancer Institute and Research Center Eugene Oregon
United States Texas Oncology, P.A. - Flower Mound Flower Mound Texas
United States Texas Oncology-Fort Worth Cancer Center Fort Worth Texas
United States Consultants in Medical Oncology and Hematology, P.C. - Abington Horsham Pennsylvania
United States Texas Oncology-Memorial City Houston Texas
United States Broome Oncology Johnson City New York
United States Texas Oncology-Midland Allison Cancer Center Midland Texas
United States Minnesota Oncology Hematology, P.A. Minneapolis Minnesota
United States Medical Oncology Hematology Consultants, PA Newark Delaware
United States Virginia Oncology Associates Norfolk Virginia
United States University of Texas at San Antonio San Antonio Texas
United States Texas Oncology-Sherman Sherman Texas
United States Northwest Cancer Specialists PC Tualatin Oregon
United States Arizona Oncology Associates, PC - HOPE Tucson Arizona
United States Texas Oncology-Tyler Tyler Texas
United States Texas Oncology -Waco Waco Texas

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  France,  Germany,  Israel,  Italy,  Japan,  Russian Federation,  Spain,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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