Clinical trial NCT03955913: A Study to Identify Participants With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations
Official title: Biomarker Study to Identify Subjects With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urothelial Cancer
Receptors, Fibroblast Growth Factor
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-05-20
Enrollment: 3679
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations.

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Percentage of Participants with Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations
timeFrame: Up to 3.9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC - HOPE
state: Arizona
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants, PA
state: Delaware
city: Chicago Ridge
country: United States
facility: Affiliated Oncologists, LLC
state: Illinois
city: Brandywine
country: United States
facility: Maryland Oncology Hematology, PA
state: Maryland
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Johnson City
country: United States
facility: Broome Oncology
state: New York
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Tualatin
country: United States
facility: Northwest Cancer Specialists PC
state: Oregon
city: Horsham
country: United States
facility: Consultants in Medical Oncology and Hematology, P.C. - Abington
state: Pennsylvania
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Denton
country: United States
facility: Texas Oncology-Denton South
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology, P.A. - Flower Mound
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology-Fort Worth Cancer Center
state: Texas
city: Houston
country: United States
facility: Texas Oncology-Memorial City
state: Texas
city: Midland
country: United States
facility: Texas Oncology-Midland Allison Cancer Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas at San Antonio
state: Texas
city: Sherman
country: United States
facility: Texas Oncology-Sherman
state: Texas
city: Tyler
country: United States
facility: Texas Oncology-Tyler
state: Texas
city: Waco
country: United States
facility: Texas Oncology -Waco
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Buenos Aires
country: Argentina
facility: CIPREC
city: Caba
country: Argentina
facility: Investigaciones Clinico Moleculares (ICM)
city: Cordoba
country: Argentina
facility: Sanatorio Allende Cerro
city: Cordoba
country: Argentina
facility: Instituto Médico de Río Cuarto
city: Cordoba
country: Argentina
facility: Hospital Privado de Cordoba
city: Córdoba
country: Argentina
facility: FUCDIM - Centro Urológico Modelo
city: Santa Fe
country: Argentina
facility: Sanatorio Mayo SA
city: Haine-Saint-Paul, La Louviere
country: Belgium
facility: Jolimont
city: Kortrijk
country: Belgium
facility: Az Groeninge
city: Liege
country: Belgium
facility: CHU de Liège - Domaine Universitaire du Sart Tilman
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Namur
country: Belgium
facility: CHU UCL Namur - Site Sainte Elisabeth
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre
city: Verviers
country: Belgium
facility: CHPLT Verviers
city: Bauru
country: Brazil
facility: NAIC - Nair Antunes Instituto do Câncer
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
city: Belo Horizonte
country: Brazil
facility: Nucleo de Ensino e Pesquisa do Instituto Mario Penna
city: Blumenau
country: Brazil
facility: Clinica de Oncologia Reichow
city: Campinas
country: Brazil
facility: Universidade Estadual De Campinas
city: Caxias Do Sul
country: Brazil
facility: Instituto Do Cancer Do Hospital Pompeia
city: Curitiba
country: Brazil
facility: Instituto de Oncologia do Paraná
city: Florianopolis
country: Brazil
facility: Ynova Pesquisa Clinica
city: Goiania
country: Brazil
facility: Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
city: Itabuna
country: Brazil
facility: SCMI Santa Casa de Misericórdia de Itabuna
city: Jau
country: Brazil
facility: Fundacao Doutor Amaral Carvalho
city: Joinville
country: Brazil
facility: Cepeville - Centro de Hematologia e Oncologia
city: Londrina
country: Brazil
facility: Hospital do Cancer de Londrina
city: Manaus
country: Brazil
facility: Instituto Sensumed de Ensino e Pesquisa Ruy França - ISENP
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
city: Ribeirao Preto
country: Brazil
facility: IRPCC - Instituto Ribeiraopretano de Combate ao Cancer
city: Salvador
country: Brazil
facility: Núcleo de Oncologia da Bahia
city: Salvador
country: Brazil
facility: Ensino e Terapia de Inovacao Clinica AMO - Etica
city: Santa Cruz Do Sul
country: Brazil
facility: Centro de Pesquisa em Oncologia Onco SG
city: Sorocaba
country: Brazil
facility: Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas
city: São Paulo
country: Brazil
facility: Hospital Paulistano
city: Três Lagoas
country: Brazil
facility: Instituto do Cancer De Tres Lagoas
city: Vitoria
country: Brazil
facility: Associacao Feminina de Educacao e Combate ao Cancer - Hospital Santa Rita de Cassia
city: Vitoria
country: Brazil
facility: CEDOES - Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda.
city: Aix En Provence
country: France
facility: Polyclinique du Parc Rambot
city: Amiens Cedex 1
country: France
facility: CHU Amiens Picardie
city: Antony
country: France
facility: Hôpital Privé d'Anthony
city: Avignon Cedex 9
country: France
facility: Institut Sainte Catherine
city: Boulogne-sur-Mer Cédex
country: France
facility: Centre Hospitalier de Boulogne-sur-Mer
city: Bourg en Bresse
country: France
facility: Hôpital de Fleyriat
city: Calais
country: France
facility: Centre Hospitalier Dr Jean-Eric TECHER
city: Chambery
country: France
facility: CH Chambéry
city: Contamine-Sur-Arve
country: France
facility: Centre Hospitalier Alpes Léman
city: Dunkerque
country: France
facility: Institut Andree DUTREIX
city: Epagny Metz-Tessy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Evreux cedex
country: France
facility: Centre Hospitalier Eure-Seine - Hopitaux d'Evreux - Vernon
city: Lyon
country: France
facility: Clinique de la Sauvegarde
city: Marseilli
country: France
facility: Hôpital Privé Clairval
city: St Quentin Cedex
country: France
facility: Ch De St Quentin
city: Valence
country: France
facility: Hôpital Privé Drome Ardèche
city: VANNES Cedex
country: France
facility: Ch Bretagne Atlantique De Vannes
city: Frankfurt
country: Germany
facility: Markus Krankenhaus Frankfurt
city: Gronau
country: Germany
facility: Prostata zentrum Nordwest
city: Herne
country: Germany
facility: Marien hospital Herne
city: Nuernberg
country: Germany
facility: MVZ Urologie 24 gGmbH
city: Riesa
country: Germany
facility: ELBLANDKLINIKUM Riesa
city: Singen
country: Germany
facility: Hegau Klinikum Singen
city: Wolfsburg
country: Germany
facility: Urologischen Praxisgemeinschaft
city: Afula
country: Israel
facility: Haemek Medical Center - Afula
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Camposampiero
country: Italy
facility: Azienda Ulss 6 Euganea- Ospedale Di Camposampiero
city: Carrara
country: Italy
facility: Ospedale Di Carrara
city: Cefalu
country: Italy
facility: Fondazione Istituto G. Giglio
city: Chieti
country: Italy
facility: Hospital SS Annunziata - University G.D'Annunzio
city: Città di Castello
country: Italy
facility: Ospedale Città Di Castello
city: Lido Di Camaiore
country: Italy
facility: Az. USL 12 di Viareggio Ospedale Versilia
city: Lucca
country: Italy
facility: Ospedale San Luca
city: Mantova
country: Italy
facility: Azienda Ospedaliera Carlo Poma
city: Milano
country: Italy
facility: Azienda Ospedaliera Ospedale San Carlo Borromeo
city: Mirano (VE)
country: Italy
facility: Ospedale Civile di Mirano
city: Napoli
country: Italy
facility: Azienda Ospedaliera 'A. Cardarelli'
city: Palermo
country: Italy
facility: Ospedale Buccheri La Ferla Fatebenefratelli
city: Palermo
country: Italy
facility: A.O.R Villa Sofia Cervello
city: Palermo
country: Italy
facility: Casa di Cura La Maddalena
city: Ponte San Pietro
country: Italy
facility: Policlinico San Pietro
city: Prato
country: Italy
facility: Nuovo Ospedale Di Prato - S. Stefano
city: Rho
country: Italy
facility: Asst Rhodense - Ospedale Di Rho
city: Rieti
country: Italy
facility: Polo Ospedaliero Unico Integrato- Presidio S.Camillo De Lellis Di Rieti
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Saronno
country: Italy
facility: Ospedale Generale Provinciale - Saronno
city: Seriate
country: Italy
facility: Ospedale Bolognini
city: Treviglio
country: Italy
facility: Ospedale Treviglio-Caravaggio
city: Verduno (CN)
country: Italy
facility: SC Oncologia ASL CN2
city: Vicenza
country: Italy
facility: Azienda Ulss 8 Berica- Ospedale Di Vicenza
city: Vimercate
country: Italy
facility: Azienda Ospedaliera "Ospedale Civile" di Vimercate - Ospedal
city: Chiba
country: Japan
facility: The Jikei University Kashiwa Hospital
city: Chiba
country: Japan
facility: Juntendo University Hospital Urayasu
city: Higashiibaraki-gun
country: Japan
facility: National Hospital Organization Mito Medical Center
city: Hokkaido
country: Japan
facility: Teine Keijinkai Hospital
city: Ibaraki
country: Japan
facility: Hitachinaka General Hospital
city: Ikeda
country: Japan
facility: Ikeda City Hospital
city: Isesaki
country: Japan
facility: Isesaki Municipal Hospital
city: Ise
country: Japan
facility: Japanese Red Cross Ise Hospital
city: Kaizuka
country: Japan
facility: Kaizuka City Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Kanonji
country: Japan
facility: Mitoyo General Hospital
city: Kawachi-Nagano
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center
city: Kiryu
country: Japan
facility: Kiryu Kosei General Hospital
city: Kisarazu-shi
country: Japan
facility: Kimitsu Chuo Hospital
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer center
city: Kitamoto
country: Japan
facility: Kitasato University Medical Center
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
city: Mito
country: Japan
facility: Japanese Red Cross Mito Hospital
city: Narita
country: Japan
facility: Japanese Red Cross Narita Hospital
city: Nerima-Ku
country: Japan
facility: Juntendo University Nerima Hospital
city: Nishi-Ku
country: Japan
facility: Kobe City Nishi-Kobe Medical Center
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Osaka
country: Japan
facility: Otemae Hospital
city: Osaka
country: Japan
facility: Osaka Police Hospital
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Osaka
country: Japan
facility: JOHAS Osaka Rosai Hospital
city: Ota
country: Japan
facility: SUBARU Health Insurance Society Ota Memorial Hospital
city: Sagamihara
country: Japan
facility: National Hospital Organization Sagamihara National Hospital
city: Sakai City
country: Japan
facility: Sakai City Medical Center
city: Sapporo
country: Japan
facility: Jinyukai Hospital
city: Tokyo
country: Japan
facility: Mitsui Memorial Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
city: Tsuchiura-City
country: Japan
facility: Tsuchiura Kyodo General Hospital
city: Tsukuba-City
country: Japan
facility: Tsukuba Medical Center Hospital
city: Anzorey
country: Russian Federation
facility: State Budgetary Healthcare Institution Inter-regional Multi-specialty Hospital
city: Chelyabinsk
country: Russian Federation
facility: LLC Evimed
city: Ekaterinburg
country: Russian Federation
facility: SHI Sverdlovsk Regional Clinical Hospital #1
city: Moscow
country: Russian Federation
facility: FSBI A.V. Vishnevsky National Medical Research Center of Surgery of the MoH RF
city: Saint-Petersburg
country: Russian Federation
facility: LLC 1 named after Berezin Sergey
city: St-Petersburg
country: Russian Federation
facility: Oncology Medical Clinics AV Medical group
city: Syktivkar
country: Russian Federation
facility: Komi Republican Oncology Dispensary
city: Tomsk
country: Russian Federation
facility: Tomsk National Research Medical Center of the Russian Academy of Sciences
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Oncology Hospital
city: Alcorcón
country: Spain
facility: Hosp. Univ. Fundacion Alcorcon
city: Barcelona
country: Spain
facility: Hosp. Gral. de Granollers
city: Cadiz
country: Spain
facility: Hosp. Puerta Del Mar
city: Donosti
country: Spain
facility: Hosp. Univ. Donostia
city: Jerez de la Frontera
country: Spain
facility: Genesiscare Jerez de La Frontera
city: Madrid
country: Spain
facility: Hosp. Univ. de La Princesa
city: Madrid
country: Spain
facility: Hosp. Univ. Del Henares
city: Oviedo
country: Spain
facility: Hosp. Univ. Central de Asturias
city: San Sebastián De Los Reyes
country: Spain
facility: Hosp. Univ. Infanta Sofia
city: Sevilla
country: Spain
facility: Hosp. Quiron Sagrado Corazon
city: Terrassa
country: Spain
facility: Hosp. de Terrassa
city: Toledo
country: Spain
facility: Hosp. Virgen de La Salud
city: Adana
country: Turkey
facility: Adana Acibadem Hospital
city: Ankara
country: Turkey
facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
city: Aydin
country: Turkey
facility: Adnan Menderes University Training and Research Hospital
city: Canakkale
country: Turkey
facility: Canakkale Onsekiz Mart University Health Practices and Research Hospital
city: Istanbul
country: Turkey
facility: Şişli Etfal Research Training Hospital
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Training and Research Hospital
city: Istanbul
country: Turkey
facility: Kartal Dr. Lutfi Kirdar Egitim ve Arastirma Hastanesi
city: Izmir
country: Turkey
facility: Izmir Katip Celebi University Ataturk Training and Research Hospital
city: Izmir
country: Turkey
facility: Izmir Medical Park Hospital
city: Kocaeli
country: Turkey
facility: Derince Egitim ve Arastirma Hastanesi
city: Konya
country: Turkey
facility: Necmettin Erbakan University Meram Medical Faculty
city: Manisa
country: Turkey
facility: Manisa Celal Bayar University
city: Samsun
country: Turkey
facility: Medical Park Samsun Hastanesi
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
city: Chernivtsi
country: Ukraine
facility: Municipal Non-profit enterprise 'Bukovinian clinical oncology center'
city: Kamianske
country: Ukraine
facility: Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council
city: Kharkiv
country: Ukraine
facility: Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval
city: Khmelnytsky
country: Ukraine
facility: Khmelnitckiy regional hospital
city: Kropyvnytskyi
country: Ukraine
facility: Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council'
city: Kyiv
country: Ukraine
facility: State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
city: Lviv
country: Ukraine
facility: Lviv Clinical Regional Hospital
city: Poltava
country: Ukraine
facility: ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'
city: Uzhgorod
country: Ukraine
facility: Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
city: Zaporizhzhia
country: Ukraine
facility: Medical Center 'Diaservis'
city: Zhytomyr
country: Ukraine
facility: Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council
city: Colchester
country: United Kingdom
facility: Colchester Hospital University NHS
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: