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AzTrials

Urothelial CancerNCT03955913

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

An observational study of Urothelial Cancer and Receptors, Fibroblast Growth Factor, run by Janssen Research & Development, LLC at 199 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Archival Tumor Tissue Sample
How many people
3,679 participants
Where
199 sitesin 14 countries
Study dates
1 Aug 2019to 19 Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations.

Who may be able to join

  • 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

Who cannot join

  • -

Trial locations and contacts

199 sites in 14 countries.

199 sites in 14 countries

Japan35 sites

  • The Jikei University Kashiwa Hospital

    Chiba, 277 -8567

  • Juntendo University Hospital Urayasu

    Chiba, 279-0021

  • National Hospital Organization Mito Medical Center

    Higashiibaraki-gun, 311-3193

  • Teine Keijinkai Hospital

    Hokkaido, 006-8555

  • Hitachinaka General Hospital

    Ibaraki, 3120057

  • Ikeda City Hospital

    Ikeda, 563-8510

  • Japanese Red Cross Ise Hospital

    Ise, 516-8512

  • Isesaki Municipal Hospital

    Isesaki, 372-0817

  • Kaizuka City Hospital

    Kaizuka, 597-0015

  • Mitoyo General Hospital

    Kan’onjichō, 769-1695

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • National Hospital Organization Osaka Minami Medical Center

    Kawachi-Nagano, 586-8521

  • Kiryu Kosei General Hospital

    Kiryū, 376-0024

  • Kimitsu Chuo Hospital

    Kisarazu-shi, 292-8535

  • Saitama Cancer center

    Kitaadachi-gun, 362-0806

  • Kitasato University Medical Center

    Kitamoto, 364-8501

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, 343-8555

  • Kitasato University Kitasato Institute Hospital

    Minatoku, 108-8642

  • Japanese Red Cross Mito Hospital

    Mito, 310-0011

  • Japanese Red Cross Narita Hospital

    Narita, 286-8523

  • Juntendo University Nerima Hospital

    Nerima-Ku, 177-8521

  • Kobe City Nishi-Kobe Medical Center

    Nishiku, 651-2273

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

  • Otemae Hospital

    Osaka, 540-0008

  • Osaka Police Hospital

    Osaka, 543-0035

  • Osaka General Medical Center

    Osaka, 558-8558

  • JOHAS Osaka Rosai Hospital

    Osaka, 591-8025

  • SUBARU Health Insurance Society Ota Memorial Hospital

    Ōta-ku, 373-8585

  • National Hospital Organization Sagamihara National Hospital

    Sagamihara, 252-0392

  • Sakai City Medical Center

    Sakai, 593-8304

  • Jinyukai Hospital

    Sapporo, 005-0002

  • Mitsui Memorial Hospital

    Tokyo, 101-8643

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Tokyo, 113-8677

  • Tsuchiura Kyodo General Hospital

    Tsuchiura, 300-0028

  • Tsukuba Medical Center Hospital

    Tsukuba, 305-8558

Other trials in Japan

Brazil25 sites

  • NAIC - Nair Antunes Instituto do Câncer

    Bauru, 17033-490

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, 30150-221

  • Nucleo de Ensino e Pesquisa do Instituto Mario Penna

    Belo Horizonte, 30380-472

  • Clinica de Oncologia Reichow

    Blumenau, 89010-340

  • Universidade Estadual De Campinas

    Campinas, 13083-888

  • Instituto Do Cancer Do Hospital Pompeia

    Caxias do Sul, 95010-005

  • Instituto de Oncologia do Paraná

    Curitiba, 80530-010

  • Ynova Pesquisa Clinica

    Florianópolis, 88020-210

  • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

    Goiânia, 74605-070

  • SCMI Santa Casa de Misericórdia de Itabuna

    Itabuna, 45603-023

  • Fundacao Doutor Amaral Carvalho

    Jaú, 17210-080

  • Cepeville - Centro de Hematologia e Oncologia

    Joinville, 89201-260

  • Hospital do Cancer de Londrina

    Londrina, 86015

  • Instituto Sensumed de Ensino e Pesquisa Ruy França - ISENP

    Manaus, 69057-250

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050-170

  • Hospital Ernesto Dornelles

    Porto Alegre, 90160-092

  • IRPCC - Instituto Ribeiraopretano de Combate ao Cancer

    Ribeirão Preto, 14015-130

  • Núcleo de Oncologia da Bahia

    Salvador, 40170-110

  • Ensino e Terapia de Inovacao Clinica AMO - Etica

    Salvador, 41950-640

  • Centro de Pesquisa em Oncologia Onco SG

    Santa Cruz do Sul, 96810110

  • Hospital Paulistano

    São Paulo, 01321-001

  • Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas

    Sorocaba, 18030-005

  • Instituto do Cancer De Tres Lagoas

    Três Lagoas, 79601-001

  • Associacao Feminina de Educacao e Combate ao Cancer - Hospital Santa Rita de Cassia

    Vitória, 29043-260

  • CEDOES - Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda.

    Vitória, 29055-450

Other trials in Brazil

Italy25 sites

  • Azienda Ulss 6 Euganea- Ospedale Di Camposampiero

    Camposampiero, 35012

  • Ospedale Di Carrara

    Carrara, 54033

  • Fondazione Istituto G. Giglio

    Cefalù, 90015

  • Hospital SS Annunziata - University G.D'Annunzio

    Chieti, 66100

  • Ospedale Città Di Castello

    Città di Castello, 06012

  • Az. USL 12 di Viareggio Ospedale Versilia

    Lido di Camaiore

  • Ospedale San Luca

    Lucca, 55100

  • Azienda Ospedaliera Carlo Poma

    Mantua, 46100

  • Azienda Ospedaliera Ospedale San Carlo Borromeo

    Milan, 20153

  • Ospedale Civile di Mirano

    Mirano (VE), 30035

  • Azienda Ospedaliera 'A. Cardarelli'

    Naples, 80131

  • Ospedale Buccheri La Ferla Fatebenefratelli

    Palermo, 90123

  • A.O.R Villa Sofia Cervello

    Palermo, 90146

  • Casa di Cura La Maddalena

    Palermo, 90146

  • Policlinico San Pietro

    Ponte San Pietro, 24100

  • Nuovo Ospedale Di Prato - S. Stefano

    Prato, 59100

  • Asst Rhodense - Ospedale Di Rho

    Rho, 20017

  • Polo Ospedaliero Unico Integrato- Presidio S.Camillo De Lellis Di Rieti

    Rieti, 20100

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144

  • Ospedale Generale Provinciale - Saronno

    Saronno, 21047

  • Ospedale Bolognini

    Seriate, 24020

  • Ospedale Treviglio-Caravaggio

    Treviglio, 24047

  • SC Oncologia ASL CN2

    Verduno (CN), 12060

  • Azienda Ulss 8 Berica- Ospedale Di Vicenza

    Vicenza, 36100

  • Azienda Ospedaliera "Ospedale Civile" di Vimercate - Ospedal

    Vimercate, 20087

Other trials in Italy

United States23 sites

  • New York Oncology Hematology

    Albany, New York, 12206

  • Maryland Oncology Hematology, PA

    Brandywine, Maryland, 20613

  • Affiliated Oncologists, LLC

    Chicago Ridge, Illinois, 60415

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Texas Oncology-Denton South

    Denton, Texas, 76210

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Texas Oncology, P.A. - Flower Mound

    Flower Mound, Texas, 75028

  • Texas Oncology-Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • Consultants in Medical Oncology and Hematology, P.C. - Abington

    Horsham, Pennsylvania, 19044

  • Texas Oncology-Memorial City

    Houston, Texas, 77024

  • Broome Oncology

    Johnson City, New York, 13790

  • Texas Oncology-Midland Allison Cancer Center

    Midland, Texas, 79701

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Medical Oncology Hematology Consultants, PA

    Newark, Delaware, 19713

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • University of Texas at San Antonio

    San Antonio, Texas, 78217

  • Texas Oncology-Sherman

    Sherman, Texas, 75090

  • Northwest Cancer Specialists PC

    Tualatin, Oregon, 97062

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85711

  • Texas Oncology-Tyler

    Tyler, Texas, 75702

  • Texas Oncology -Waco

    Waco, Texas, 76712

Other trials in United States

France17 sites

  • Polyclinique du Parc Rambot

    Aix-en-Provence, 13090

  • CHU Amiens Picardie

    Amiens, 80054

  • Hôpital Privé d'Anthony

    Antony, 92160

  • Institut Sainte Catherine

    Avignon, 84918

  • Centre Hospitalier de Boulogne-sur-Mer

    Boulogne-sur-Mer Cédex, 62321

  • Hôpital de Fleyriat

    Bourg-en-Bresse, 01012

  • Centre Hospitalier Dr Jean-Eric TECHER

    Calais, 62100

  • CH Chambéry

    Chambéry, 73000

  • Centre Hospitalier Alpes Léman

    Contamine-sur-Arve, 74130

  • Institut Andree DUTREIX

    Dunkirk, 59240

  • Centre Hospitalier Annecy Genevois

    Epagny Metz-Tessy, 74370

  • Centre Hospitalier Eure-Seine - Hopitaux d'Evreux - Vernon

    Évreux, 27015

  • Clinique de la Sauvegarde

    Lyon, 69009

  • Hôpital Privé Clairval

    Marseilli, 13009

  • Ch De St Quentin

    Saint-Quentin, 2321

  • Hôpital Privé Drome Ardèche

    Valence, 26000

  • Ch Bretagne Atlantique De Vannes

    Vannes, 56017

Other trials in France

Turkey (Türkiye)14 sites

  • Adana Acibadem Hospital

    Adana, 1130

  • Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 6200

  • Adnan Menderes University Training and Research Hospital

    Aydin, 09100

  • Canakkale Onsekiz Mart University Health Practices and Research Hospital

    Çanakkale, 17110

  • Şişli Etfal Research Training Hospital

    Istanbul, 34371

  • Haydarpasa Numune Training and Research Hospital

    Istanbul, 34668

  • Kartal Dr. Lutfi Kirdar Egitim ve Arastirma Hastanesi

    Istanbul, 34890

  • Izmir Katip Celebi University Ataturk Training and Research Hospital

    Izmir, 35360

  • Izmir Medical Park Hospital

    Izmir, 35575

  • Derince Egitim ve Arastirma Hastanesi

    Kocaeli, 41900

  • Necmettin Erbakan University Meram Medical Faculty

    Konya, 42080

  • Manisa Celal Bayar University

    Manisa, 45030

  • Medical Park Samsun Hastanesi

    Samsun, 55200

  • Ondokuz Mayis University

    Samsun, 55200

Other trials in Turkey (Türkiye)

Spain12 sites

  • Hosp. Univ. Fundacion Alcorcon

    Alcorcón, 28922

  • Hosp. Gral. de Granollers

    Barcelona, 08400

  • Hosp. Puerta Del Mar

    Cadiz, 11009

  • Hosp. Univ. Donostia

    Donostia / San Sebastian, 20080

  • Genesiscare Jerez de La Frontera

    Jerez de la Frontera, 11407

  • Hosp. Univ. de La Princesa

    Madrid, 28006

  • Hosp. Univ. Del Henares

    Madrid, 28822

  • Hosp. Univ. Central de Asturias

    Oviedo, 33011

  • Hosp. Univ. Infanta Sofia

    San Sebastián de los Reyes, 28702

  • Hosp. Quiron Sagrado Corazon

    Seville, 41013

  • Hosp. de Terrassa

    Terrassa, 08227

  • Hosp. Virgen de La Salud

    Toledo, 45004

Other trials in Spain

Ukraine11 sites

  • Municipal Non-profit enterprise 'Bukovinian clinical oncology center'

    Chernivtsi, 58013

  • Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council

    Kamyanske, 51900

  • Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval

    Kharkiv, 61037

  • Khmelnitckiy regional hospital

    Khmelnytsky, 29000

  • Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council'

    Kropyvnytskyi, 25011

  • State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center

    Kyiv, 03115

  • Lviv Clinical Regional Hospital

    Lviv, 79031

  • ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'

    Poltava, 36024

  • Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

    Uzhhorod, 88000

  • Medical Center 'Diaservis'

    Zaporizhzhya, 69076

  • Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council

    Zhytomyr, 10002

Other trials in Ukraine

Russia9 sites

  • State Budgetary Healthcare Institution Inter-regional Multi-specialty Hospital

    Anzorey, 361336

  • LLC Evimed

    Chelyabinsk, 454048

  • FSBI A.V. Vishnevsky National Medical Research Center of Surgery of the MoH RF

    Moscow, 17997

  • LLC 1 named after Berezin Sergey

    Saint Petersburg, 194354

  • Oncology Medical Clinics AV Medical group

    Saint Petersburg, 196006

  • Komi Republican Oncology Dispensary

    Syktivkar, 167094

  • Tomsk National Research Medical Center of the Russian Academy of Sciences

    Tomsk, 634009

  • Yaroslavl Regional Clinical Oncology Hospital

    Yaroslavl, 150054

  • SHI Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, 620102

Other trials in Russia

Argentina7 sites

  • CIPREC

    Buenos Aires, C1119ACN

  • Investigaciones Clinico Moleculares (ICM)

    CABA, C1425

  • FUCDIM - Centro Urológico Modelo

    Córdoba, 5008

  • Sanatorio Allende Cerro

    Córdoba, X5021FPQ

  • Instituto Médico de Río Cuarto

    Córdoba, X5800

  • Hospital Privado de Cordoba

    Córdoba, XX5016KEH

  • Sanatorio Mayo SA

    Santa Fe, S3000AZH

Other trials in Argentina

Belgium7 sites

  • Jolimont

    Haine-Saint-Paul, La Louviere, 7100

  • Az Groeninge

    Kortrijk, 8500

  • CHU de Liège - Domaine Universitaire du Sart Tilman

    Liège, 4000

  • ZNA Jan Palfijn

    Merksem, 2170

  • CHU UCL Namur - Site Sainte Elisabeth

    Namur, 5000

  • Clinique Saint Pierre

    Ottignies, 1340

  • CHPLT Verviers

    Verviers, 4800

Other trials in Belgium

Germany7 sites

  • Markus Krankenhaus Frankfurt

    Frankfurt, 60431

  • Prostata zentrum Nordwest

    Gronau, 48599

  • Marien hospital Herne

    Herne, 44625

  • MVZ Urologie 24 gGmbH

    Nuremberg, 90491

  • ELBLANDKLINIKUM Riesa

    Riesa, 1589

  • Hegau Klinikum Singen

    Singen, 78224

  • Urologischen Praxisgemeinschaft

    Wolfsburg, 38440

Other trials in Germany

United Kingdom5 sites

  • Colchester Hospital University NHS

    Colchester, CO4 5JL

  • Royal Devon & Exeter Hospital

    Exeter, EX2 5DW

  • The Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, CH63 4JY

  • Queen Alexandra Hospital

    Portsmouth, PO6 3LY

  • Royal Preston Hospital

    Preston, PR2 9HT

Other trials in United Kingdom

Israel2 sites

  • Haemek Medical Center - Afula

    Afula, 1834111

  • Carmel Medical Center

    Haifa, 3436212

Other trials in Israel

About this study

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

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.

Being tested
Archival Tumor Tissue Sample
Medical subject headings
Acrocephalosyndactylia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Archival Tumor Tissue SampleOther

    Percentage of participants with UC and selected FGFR aberrations will be assessed through molecular testing of their archival tumor tissue.

Study groups in NCT03955913
Study groupRoleWhat they receive
Participants with Urothelial Cancer,selected FGFR aberrationsParticipants 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.
Receives: Other: Archival Tumor Tissue Sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 3.9 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2019
  2. Study start1 Aug 2019
  3. Primary completion19 Sep 2022
  4. Study completion19 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,679 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03955913
Sponsor's protocol ID
CR108627
Other IDs
42756493BLC0002
Status last verified
Feb 2023
First submitted
17 May 2019
Last updated
24 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Urothelial Cancer and Receptors, Fibroblast Growth Factor, run by Janssen Research & Development, LLC at 199 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 199 sites in Japan, Brazil, Italy, United States, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations (time frame: Up to 3.9 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03955913.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.

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