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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 2, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date May 17, 2019
First Posted Date May 20, 2019
Last Update Posted Date December 2, 2022
Actual Study Start Date August 1, 2019
Estimated Primary Completion Date June 9, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2021)
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.
Original Primary Outcome Measures
 (submitted: May 17, 2019)
  • Percentage of Participants with Urothelial Cancer (UC) [ Time Frame: Approximately 1.3 years ]
    Percentage of participants with UC will be assessed through molecular testing of their archival tumor tissue.
  • Percentage of Participants with Selected Fibroblast Growth Factor Receptor (FGFR) Aberrations [ Time Frame: Approximately 1.3 years ]
    Percentage of participants with selected FGFR aberrations will be assessed through molecular testing of their archival tumor tissue.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations.
Condition
  • Urothelial Cancer
  • Receptors, Fibroblast Growth Factor
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Other: Archival Tumor Tissue Sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: December 1, 2022)
3702
Original Estimated Enrollment
 (submitted: May 17, 2019)
2000
Estimated Study Completion Date June 9, 2023
Estimated Primary Completion Date June 9, 2023   (Final data collection date for primary outcome measure)
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:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina,   Belgium,   Brazil,   France,   Germany,   Israel,   Italy,   Japan,   Russian Federation,   Spain,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number NCT03955913
Other Study ID Numbers CR108627
42756493BLC0002 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Janssen Research & Development, LLC
Original Responsible Party Same as current
Current Study Sponsor Janssen Research & Development, LLC
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date December 2022