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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03955913|
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : July 15, 2022
|Condition or disease||Intervention/treatment|
|Urothelial Cancer Receptors, Fibroblast Growth Factor||Other: Archival Tumor Tissue Sample|
|Study Type :||Observational|
|Estimated Enrollment :||4000 participants|
|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 :||April 4, 2023|
|Estimated Study Completion Date :||June 9, 2023|
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.
- 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.
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
|Contact: Study Contact||844-434-4210||Participate-In-This-Study@its.jnj.com|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|