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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bladder Cancer

Intervention / Treatment
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* Diagnostic Test: FGFR test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BC<br>Patients who were diagnosed with bladder cancer | Diagnostic Test: FGFR test<br>* Detection of FGFR gene mutations in the tumor tissue and urine of patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between FGFR mutations found in bladder cancer tissues and urine before and after treatment | The ratio of patients with matching test results to total patients | Up to two weeks before and after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in FGFR mutations in tissues 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. | Up to two weeks before and after treatment | 
| Patient prognosis | recurrence-free | six months and one year after treatment | 
| Patient prognosis | progression-free | six months and one year after treatment | 
| Patient prognosis | cancer-specific survivals | six months and one year after treatment | 
| Patient prognosis | overall survivals | six months and one year after treatment | 
| PD-L1 expression | PD-L1 expression level will be measured using immunohistochemistry, RNA sequencing, and other suitable methods to analyze the bladder cancer subtypes | Up to two weeks before and after treatment |