NCT04339933

Detection of FGFR Gene Mutations in the Tumor Tissue and Urine of Patients With Urothelial Carcinoma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 92 (estimated)
• Sponsor: Ho Kyung Seo · Other Government
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FGFR test	Detection of FGFR gene mutations in the tumor tissue and urine of patients

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-12-31
• Completion: 2025-03-31
• First posted: 2020-04-09
• Last updated: 2022-04-07