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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03955913
Recruitment Status : Active, not recruiting
First Posted : May 20, 2019
Last Update Posted : December 29, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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.

Condition or disease Intervention/treatment
Urothelial Cancer Receptors, Fibroblast Growth Factor Other: Archival Tumor Tissue Sample

Study Design
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Study Type : Observational
Actual Enrollment : 3693 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarker Study to Identify Subjects With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : June 9, 2023
Estimated Study Completion Date : June 9, 2023

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Participants with Urothelial Cancer,selected FGFR aberrations
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations [ Time Frame: Up to 3.9 years ]
    Percentage of participants with selected FGFR gene aberrations will be assessed through molecular testing of their archival tumor tissue.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations.
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:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955913


Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03955913    
Other Study ID Numbers: CR108627
42756493BLC0002 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: December 29, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Device Product: No