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

Ho Kyung Seo

Status: Not yet enrolling

Conditions: Bladder Cancer

Treatments: Diagnostic Test: FGFR test

Study type: Observational

Funder types: Other

Identifiers

NCT04339933

U-FGFR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

92 participants in 1 patient group

BC

Description:

Patients who were diagnosed with bladder cancer

Treatment:

Diagnostic Test: FGFR test