Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-01-04 @ 4:46 PM
Study NCT ID:
NCT04339933
Status:
UNKNOWN
Last Update Posted:
2022-04-07
First Post:
2020-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of FGFR Gene Mutations in the Tumor Tissue and Urine of Patients With Urothelial Carcinoma
Sponsor:
Ho Kyung Seo
Organization:
Study Overview
Official Title:
Detection of FGFR Gene Mutations in the Tumor Tissue and Urine of Patients With Urothelial Carcinoma
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to compare the correlation between FGFR mutations found in bladder cancer tissues and urine to develop a companion diagnostic method for predicting the effect of FGFR inhibitors using urine samples of the patients with urothelial cancer.
Detailed Description:
This study targets 92 patients with urothelial cancer, whose tissue (from scheduled surgery) and urine samples can be obtained, regardless of the treatment stage.
■ Examination Methods
* FGFR mutations in bladder cancer tissues will be analyzed using next-generation sequencing and current companion diagnostic methods.
* FGFR mutations in urine samples obtained from patients with bladder cancer will be analyzed using nanowires.
* Bladder cancer subtyping will be performed by RNA sequencing of tumor tissues or other methods.
* Analysis of paired tissues before and after chemotherapy will be performed on transurethral resection of bladder tumor (TUR-BT) and cystectomy tissues before and after neoadjuvant chemotherapy.
■ Examination Methods
* FGFR mutations in bladder cancer tissues will be analyzed using next-generation sequencing and current companion diagnostic methods.
* FGFR mutations in urine samples obtained from patients with bladder cancer will be analyzed using nanowires.
* Bladder cancer subtyping will be performed by RNA sequencing of tumor tissues or other methods.
* Analysis of paired tissues before and after chemotherapy will be performed on transurethral resection of bladder tumor (TUR-BT) and cystectomy tissues before and after neoadjuvant chemotherapy.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: