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出境医 / 临床实验 / A Study to Identify Participants With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations

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

Study Description
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
Estimated Enrollment : 2000 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 : May 3, 2024
Estimated Study Completion Date : May 10, 2024
Arms and Interventions
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
Primary Outcome Measures :
  1. 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.

  2. 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.


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 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:

-

Contacts and Locations

Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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