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

Not yet recruiting

• Conditions: Bladder Cancer
• Interventions: Diagnostic Test: FGFR test

• Registration Number: NCT04339933
• Lead Sponsor: Ho Kyung Seo

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.

Study Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-09
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07
• Study Start: 2022-05-01
• Primary Completion: 2022-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Suspected patients of urothelial cancer who will visit the National Cancer Center Korea from the date of Institutional Review Board (IRB) approval to 2021 and with identified tumors in the bladder according to bladder endoscopy.
• Subjects who are scheduled for surgery (transurethral bladder tumor resection, radical bladder resection, and radical bladder ureterectomy) and have agreed to participate in the study

Exclusion Criteria

• History of other active malignant tumors treated within 24 months
• Patients with either mental illness or who cannot participate in clinical trials at the judgment of other doctors
• If patients and guardians do not want to participate in this study
• History of having administered FGFR inhibitors in the past

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BC	FGFR test	Patients who were diagnosed with bladder cancer

Primary Outcome Measures

Name	Time	Method
Correlation between FGFR mutations found in bladder cancer tissues and urine before and after treatment	Up to two weeks before and after surgery	The ratio of patients with matching test results to total patients

Secondary Outcome Measures

Name	Time	Method
PD-L1 expression	Up to two weeks before and after treatment	PD-L1 expression level will be measured using immunohistochemistry, RNA sequencing, and other suitable methods to analyze the bladder cancer subtypes
Patient prognosis	six months and one year after treatment	overall survivals
Changes in FGFR mutations in tissues before and after treatment	Up to two weeks before and after treatment	Changes in FGFR mutations in tissues before and after treatment will be observed in the patients with muscle-invasive and non-muscle-invasive bladder cancer undergoing neoadjuvant chemotherapy and transurethral bladder tumor resection, respectively, due to recurrence.