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Brief Title: Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations

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

INTRODUCTION

  • Org Study ID: CR108627
  • Secondary ID: 42756493BLC0002
  • NTC ID: NCT03955913
  • Sponsor: Janssen Research & Development, LLC
To learn how to participate in this trial please click here.

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.

  • Overall Status
    Recruiting
  • Start Date
    August 1, 2019
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Percentage of Participants with Urothelial Cancer (UC)

Primary Outcome 1 - Timeframe: Approximately 1.3 years

Primary Outcome 2 - Measure: Percentage of Participants with Selected Fibroblast Growth Factor Receptor (FGFR) Aberrations

Primary Outcome 2 - Timeframe: Approximately 1.3 years

CONDITION

  • Urothelial Cancer
  • Receptors
  • Fibroblast Growth Factor

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 who are at high risk for progression to advanced disease as assessed by the investigator or,c) 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:
-

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Janssen Research & Development, LLC Clinical Trial

Role: Study Director

Affiliation: Janssen Research & Development, LLC

Overall Contact

Name: Janssen Research & Development, LLC Clinical Trial

Phone: 844-434-4210

Email: JNJ.CT@sylogent.com

LOCATION

Facility Status Contact
Facility: Arizona Oncology Associates, PC - HOPE
Tucson, Arizona 85711
United States
Status: Recruiting Contact: N/A
Facility: Rocky Mountain Cancer Centers
Denver, Colorado 80218
United States
Status: Recruiting Contact: N/A
Facility: Medical Oncology Hematology Consultants, PA
Newark, Delaware 19713
United States
Status: Recruiting Contact: N/A
Facility: Affiliated Oncologists, LLC
Chicago Ridge, Illinois 60415
United States
Status: Recruiting Contact: N/A
Facility: Maryland Oncology Hematology, PA
Brandywine, Maryland 20613
United States
Status: Recruiting Contact: N/A
Facility: Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota 55404
United States
Status: Recruiting Contact: N/A
Facility: New York Oncology Hematology
Albany, New York 12206
United States
Status: Recruiting Contact: N/A
Facility: Broome Oncology
Johnson City, New York 13790
United States
Status: Recruiting Contact: N/A
Facility: Oncology Hematology Care
Cincinnati, Ohio 45242
United States
Status: Recruiting Contact: N/A
Facility: Willamette Valley Cancer Institute and Research Center
Eugene, Oregon 97401
United States
Status: Recruiting Contact: N/A
Facility: Northwest Cancer Specialists PC
Tualatin, Oregon 97062
United States
Status: Recruiting Contact: N/A
Facility: Consultants in Medical Oncology and Hematology, P.C. - Abington
Horsham, Pennsylvania 19044
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology-Denton South
Denton, Texas 76210
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology, P.A. - Flower Mound
Flower Mound, Texas 75028
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas 76104
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology-Memorial City
Houston, Texas 77024
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology-Midland Allison Cancer Center
Midland, Texas 79701
United States
Status: Recruiting Contact: N/A
Facility: University of Texas at San Antonio
San Antonio, Texas 78217
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology-Sherman
Sherman, Texas 75090
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology-Tyler
Tyler, Texas 75702
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology -Waco
Waco, Texas 76712
United States
Status: Recruiting Contact: N/A
Facility: Virginia Oncology Associates
Norfolk, Virginia 23502
United States
Status: Recruiting Contact: N/A
Facility: CIPREC
Buenos Aires, C1119ACN
Argentina
Status: Recruiting Contact: N/A
Facility: Investigaciones Clinico Moleculares (ICM)
Caba, C1425
Argentina
Status: Recruiting Contact: N/A
Facility: Sanatorio Allende Cerro
Cordoba, X5021FPQ
Argentina
Status: Recruiting Contact: N/A
Facility: Instituto Médico de Río Cuarto
Cordoba, X5800
Argentina
Status: Recruiting Contact: N/A
Facility: Hospital Privado de Cordoba
Cordoba, XX5016KEH
Argentina
Status: Recruiting Contact: N/A
Facility: Sanatorio Mayo SA
Santa Fe, S3000AZH
Argentina
Status: Recruiting Contact: N/A
Facility: NAIC - Nair Antunes Instituto do Câncer
Bauru, 17033-490
Brazil
Status: Recruiting Contact: N/A
Facility: Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150-221
Brazil
Status: Recruiting Contact: N/A
Facility: Associação Mário Penna/Núcleo de Ensino e Pesquisas
Belo Horizonte, 30380-472
Brazil
Status: Recruiting Contact: N/A
Facility: Clinica de Oncologia Reichow
Blumenau, 89010-340
Brazil
Status: Recruiting Contact: N/A
Facility: Instituto Do Cancer Do Hospital Pompeia
Caxias Do Sul, 95010-005
Brazil
Status: Recruiting Contact: N/A
Facility: Instituto de Oncologia do Paraná
Curitiba, 80530-010
Brazil
Status: Recruiting Contact: N/A
Facility: Ynova Pesquisa Clinica
Florianopolis, 88020-210
Brazil
Status: Recruiting Contact: N/A
Facility: SCMI Santa Casa de Misericórdia de Itabuna
Itabuna, 45603-023
Brazil
Status: Recruiting Contact: N/A
Facility: Centro de Pesquisas do Hospital Amaral Carvalho
Jaú, 17210-080
Brazil
Status: Recruiting Contact: N/A
Facility: Cepeville - Centro de Hematologia e Oncologia
Joinville, 89201-260
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital do Cancer de Londrina
Londrina, 86015
Brazil
Status: Recruiting Contact: N/A
Facility: Instituto SENSUMED de Ensino e Pesquisa - Ruy França
Manaus, 69057-250
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital Ernesto Dornelles
Porto Alegre, 90160-092
Brazil
Status: Recruiting Contact: N/A
Facility: IRPCC - Instituto Ribeiraopretano de Combate ao Cancer
Ribeirao Preto, 14015-130
Brazil
Status: Recruiting Contact: N/A
Facility: Núcleo de Oncologia da Bahia
Salvador, 40170-110
Brazil
Status: Recruiting Contact: N/A
Facility: Instituto Etica - Amo
Salvador, 96810110
Brazil
Status: Recruiting Contact: N/A
Facility: Centro de Pesquisa em Oncologia Onco SG
Santa Cruz Do Sul, 18030-005
Brazil
Status: Recruiting Contact: N/A
Facility: Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas
Sorocaba, 01321-001
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital Paulistano
São Paulo, 79601-001
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital Santa Rita
Vitoria, 29055450
Brazil
Status: Recruiting Contact: N/A
Facility: CEDOES
Vitoria, 13090
Brazil
Status: Recruiting Contact: N/A
Facility: Polyclinique du Parc Rambot
Aix En Provence, 80054
France
Status: Recruiting Contact: N/A
Facility: CHU Amiens Picardie
Amiens Cedex 1, 92160
France
Status: Recruiting Contact: N/A
Facility: Hôpital Privé d'Anthony
Antony, 84918
France
Status: Recruiting Contact: N/A
Facility: Institut Sainte Catherine
Avignon Cedex 9, 01012
France
Status: Recruiting Contact: N/A
Facility: Hôpital de Fleyriat
Bourg en Bresse, 74130
France
Status: Recruiting Contact: N/A
Facility: Centre Hospitalier Alpes Léman
Contamine-Sur-Arve, 69009
France
Status: Recruiting Contact: N/A
Facility: Clinique de la Sauvegarde
Lyon, 13009
France
Status: Recruiting Contact: N/A
Facility: Hôpital Privé Clairval
Marseilli, 45067
France
Status: Recruiting Contact: N/A
Facility: Ch De St Quentin
St Quentin Cedex, 26000
France
Status: Recruiting Contact: N/A
Facility: Hôpital Privé Drome Ardèche
Valence, 28277
France
Status: Recruiting Contact: N/A
Facility: Markus Krankenhaus Frankfurt
Frankfurt, 48599
Germany
Status: Recruiting Contact: N/A
Facility: Prostata zentrum Nordwest
Gronau, 44625
Germany
Status: Recruiting Contact: N/A
Facility: Marien hospital Herne
Herne, 90419
Germany
Status: Recruiting Contact: N/A
Facility: MVZ Urologie 24 gGmbH
Nuernberg, 1589
Germany
Status: Recruiting Contact: N/A
Facility: ELBLANDKLINIKUM Riesa
Riesa, 78224
Germany
Status: Recruiting Contact: N/A
Facility: Hegau Klinikum Singen
Singen, 70176
Germany
Status: Recruiting Contact: N/A
Facility: Urologischen Praxisgemeinschaft
Wolfsburg, 1834111
Germany
Status: Recruiting Contact: N/A
Facility: Haemek Medical Center - Afula
Afula, 3436212
Israel
Status: Recruiting Contact: N/A
Facility: Carmel Medical Center
Haifa, 35012
Israel
Status: Recruiting Contact: N/A
Facility: Azienda Ulss 6 Euganea- Ospedale Di Camposampiero
Camposampiero, 54033
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale Di Carrara
Carrara, 95027
Italy
Status: Recruiting Contact: N/A
Facility: Fondazione Istituto G. Giglio
Cefalu, 66100
Italy
Status: Recruiting Contact: N/A
Facility: Hospital SS Annunziata - University G.D'Annunzio
Chieti, 06012
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale Città Di Castello
Città di Castello, 55100
Italy
Status: Recruiting Contact: N/A
Facility: Az. USL 12 di Viareggio Ospedale Versilia
Lido Di Camaiore, 46100
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale San Luca
Lucca, 20153
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera Carlo Poma
Mantova, 30035
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera Ospedale San Carlo Borromeo
Milano, 80131
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale Civile di Mirano
Mirano (VE), 80131
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera 'A. Cardarelli'
Napoli, 90123
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale Buccheri La Ferla Fatebenefratelli
Palermo, 90146
Italy
Status: Recruiting Contact: N/A
Facility: A.O.R Villa Sofia Cervello
Palermo, 24100
Italy
Status: Recruiting Contact: N/A
Facility: Casa di Cura La Maddalena
Palermo, 59100
Italy
Status: Recruiting Contact: N/A
Facility: Policlinico San Pietro
Ponte San Pietro, 20017
Italy
Status: Recruiting Contact: N/A
Facility: Nuovo Ospedale Di Prato - S. Stefano
Prato, 20100
Italy
Status: Recruiting Contact: N/A
Facility: Asst Rhodense - Ospedale Di Rho
Rho, 00144
Italy
Status: Recruiting Contact: N/A
Facility: Polo Ospedaliero Unico Integrato- Presidio S.Camillo De Lellis Di Rieti
Rieti, 21047
Italy
Status: Recruiting Contact: N/A
Facility: Istituto Nazionale Tumori Regina Elena
Roma, 24020
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale Generale Provinciale - Saronno
Saronno, 20090
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale Bolognini
Seriate, 24047
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale Treviglio-Caravaggio
Treviglio, 36100
Italy
Status: Recruiting Contact: N/A
Facility: SC Oncologia ASL CN2
Verduno (CN), 20087
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ulss 8 Berica- Ospedale Di Vicenza
Vicenza, 277 -8567
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera "Ospedale Civile" di Vimercate - Ospedal
Vimercate, 279-0021
Italy
Status: Recruiting Contact: N/A
Facility: The Jikei University Kashiwa Hospital
Chiba, 311-3193
Japan
Status: Recruiting Contact: N/A
Facility: National Hospital Organization Mito Medical Center
Higashiibaraki-gun, 3120057
Japan
Status: Recruiting Contact: N/A
Facility: Teine Keijinkai Hospital
Hokkaido, 630-0293
Japan
Status: Recruiting Contact: N/A
Facility: Hitachinaka General Hospital
Ibaraki, 372-0817
Japan
Status: Recruiting Contact: N/A
Facility: Isesaki Municipal Hospital
Isesaki, 597-0015
Japan
Status: Recruiting Contact: N/A
Facility: Japanese Red Cross Ise Hospital
Ise, 241-8515
Japan
Status: Recruiting Contact: N/A
Facility: Kaizuka City Hospital
Kaizuka, 769-1695
Japan
Status: Recruiting Contact: N/A
Facility: Kanagawa Cancer Center
Kanagawa, 586-8521
Japan
Status: Recruiting Contact: N/A
Facility: Mitoyo General Hospital
Kanonji, 376-0024
Japan
Status: Recruiting Contact: N/A
Facility: Kiryu Kosei General Hospital
Kiryu, 362-0806
Japan
Status: Recruiting Contact: N/A
Facility: Kimitsu Chuo Hospital
Kisarazu, 364-8501
Japan
Status: Recruiting Contact: N/A
Facility: Saitama Cancer center
Kitaadachi-gun, 343-8555
Japan
Status: Recruiting Contact: N/A
Facility: Kitasato University Medical Center
Kitamoto, 108-8642
Japan
Status: Recruiting Contact: N/A
Facility: Japanese Red Cross Narita Hospital
Narita, 651-2273
Japan
Status: Recruiting Contact: N/A
Facility: Kobe City Nishi-Kobe Medical Center
Nishi-Ku, 540-0008
Japan
Status: Recruiting Contact: N/A
Facility: National Hospital Organization Osaka National Hospital
Osaka, 543-0035
Japan
Status: Recruiting Contact: N/A
Facility: Otemae Hospital
Osaka, 558-8558
Japan
Status: Recruiting Contact: N/A
Facility: Osaka Police Hospital
Osaka, 591-8025
Japan
Status: Recruiting Contact: N/A
Facility: Osaka General Medical Center
Osaka, 373-8585
Japan
Status: Recruiting Contact: N/A
Facility: JOHAS Osaka Rosai Hospital
Osaka, 252-0392
Japan
Status: Recruiting Contact: N/A
Facility: SUBARU Health Insurance Society Ota Memorial Hospital
Ota, 593-8304
Japan
Status: Recruiting Contact: N/A
Facility: National Hospital Organization Sagamihara National Hospital
Sagamihara, 005-0002
Japan
Status: Recruiting Contact: N/A
Facility: Sakai City Medical Center
Sakai City, 101-8643
Japan
Status: Recruiting Contact: N/A
Facility: Jinyukai Hospital
Sapporo, 113-8677
Japan
Status: Recruiting Contact: N/A
Facility: Mitsui Memorial Hospital
Tokyo, 300-0028
Japan
Status: Recruiting Contact: N/A
Facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Tokyo, 305-8558
Japan
Status: Recruiting Contact: N/A
Facility: Tsuchiura Kyodo General Hospital
Tsuchiura-City, 1800 AM
Japan
Status: Recruiting Contact: N/A
Facility: Tsukuba Medical Center Hospital
Tsukuba-City, 3813 TZ
Japan
Status: Recruiting Contact: N/A
Facility: State Budgetary Healthcare Institution Inter-regional Multi-specialty Hospital
Anzorey, 620102
Russian Federation
Status: Recruiting Contact: N/A
Facility: LLC Evimed
Chelyabinsk, 105425
Russian Federation
Status: Recruiting Contact: N/A
Facility: SHI Sverdlovsk Regional Clinical Hospital #1
Ekaterinburg, 123001
Russian Federation
Status: Recruiting Contact: N/A
Facility: FSBI A.V. Vishnevsky National Medical Research Center of Surgery of the MoH RF
Moscow, 194044
Russian Federation
Status: Recruiting Contact: N/A
Facility: LLC 1 named after Berezin Sergey
Saint-Petersburg, 214031
Russian Federation
Status: Recruiting Contact: N/A
Facility: Oncology Medical Clinics AV Medical group
Saint-Petersburg, 167094
Russian Federation
Status: Recruiting Contact: N/A
Facility: Tomsk National Research Medical Center of the Russian Academy of Sciences
Tomsk, 28922
Russian Federation
Status: Recruiting Contact: N/A
Facility: Yaroslavl Regional Clinical Oncology Hospital
Yaroslavl, 08400
Russian Federation
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Fundacion Alcorcon
Alcorcón, 11009
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Gral. de Granollers
Barcelona, 20080
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Puerta Del Mar
Cadiz, 11407
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Donostia
Donosti, 28006
Spain
Status: Recruiting Contact: N/A
Facility: Genesiscare Jerez de La Frontera
Jerez de la Frontera, 28822
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. de La Princesa
Madrid, 33011
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Del Henares
Madrid, 28702
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Central de Asturias
Oviedo, 41013
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Quiron Sagrado Corazon
Sevilla, 45004
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. de Terrassa
Terrassa, 1130
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Virgen de La Salud
Toledo, 6200
Spain
Status: Recruiting Contact: N/A
Facility: Adana Acibadem Hospital
Adana, 09100
Turkey
Status: Recruiting Contact: N/A
Facility: Canakkale Onsekiz Mart University Health Practices and Research Hospital
Canakkale, 34668
Turkey
Status: Recruiting Contact: N/A
Facility: Haydarpasa Numune Training and Research Hospital
Istanbul, 35360
Turkey
Status: Recruiting Contact: N/A
Facility: Kartal Dr. Lutfi Kirdar Egitim ve Arastirma Hastanesi
Istanbul, 35575
Turkey
Status: Recruiting Contact: N/A
Facility: Izmir Katip Celebi University Ataturk Training and Research Hospital
Izmir, 41900
Turkey
Status: Recruiting Contact: N/A
Facility: Izmir Medical Park Hospital
Izmir, 42080
Turkey
Status: Recruiting Contact: N/A
Facility: Necmettin Erbakan University Meram Medical Faculty
Konya, 55200
Turkey
Status: Recruiting Contact: N/A
Facility: Manisa Celal Bayar University
Manisa, 58013
Turkey
Status: Recruiting Contact: N/A
Facility: Medical Park Samsun Hastanesi
Samsun, 51900
Turkey
Status: Recruiting Contact: N/A
Facility: Municipal Non-profit enterprise 'Bukovinian clinical oncology center'
Chernivtsi, 61037
Ukraine
Status: Recruiting Contact: N/A
Facility: Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council
Kamianske, 29000
Ukraine
Status: Recruiting Contact: N/A
Facility: Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval
Kharkiv, 25011
Ukraine
Status: Recruiting Contact: N/A
Facility: Khmelnitckiy regional hospital
Khmelnytsky, 03115
Ukraine
Status: Recruiting Contact: N/A
Facility: Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council'
Kropyvnytskyi, 79031
Ukraine
Status: Recruiting Contact: N/A
Facility: State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
Kyiv, 36024
Ukraine
Status: Recruiting Contact: N/A
Facility: Lviv Clinical Regional Hospital
Lviv, 46023
Ukraine
Status: Recruiting Contact: N/A
Facility: ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'
Poltava, 88000
Ukraine
Status: Recruiting Contact: N/A
Facility: Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
Uzhgorod, 10002
Ukraine
Status: Recruiting Contact: N/A
Facility: Medical Center 'Diaservis'
Zaporizhzhia, CO4 5JL
Ukraine
Status: Recruiting Contact: N/A
Facility: Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council
Zhytomyr, EX2 5DW
Ukraine
Status: Recruiting Contact: N/A
Facility: Colchester Hospital University NHS
Colchester, PO6 3LY
United Kingdom
Status: Recruiting Contact: N/A
Facility: Royal Devon & Exeter Hospital
Exeter, PR2 9HT
United Kingdom
Status: Recruiting Contact: N/A
Facility: Queen Alexandra Hospital
Portsmouth, CH63 4JY
United Kingdom
Status: Recruiting Contact: N/A
Facility: Royal Preston Hospital
Preston,
United Kingdom
Status: Recruiting Contact: N/A
Facility: The Clatterbridge Cancer Centre
Wirral,
United Kingdom
Status: Recruiting Contact: N/A