Detection of FGFR Gene Mutations in the Tumor Tissue and Urine of Patients With Urothelial Carcinoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
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FGFR mutations in bladder cancer tissues will be analyzed using next-generation sequencing and current companion diagnostic methods.
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FGFR mutations in urine samples obtained from patients with bladder cancer will be analyzed using nanowires.
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Bladder cancer subtyping will be performed by RNA sequencing of tumor tissues or other methods.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| BC Patients who were diagnosed with bladder cancer |
Diagnostic Test: FGFR test
Detection of FGFR gene mutations in the tumor tissue and urine of patients
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
- Patient prognosis [six months and one year after treatment]
recurrence-free
- Patient prognosis [six months and one year after treatment]
progression-free
- Patient prognosis [six months and one year after treatment]
cancer-specific survivals
- Patient prognosis [six months and one year after treatment]
overall survivals
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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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:
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History of other active malignant tumors treated within 24 months
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Patients with either mental illness or who cannot participate in clinical trials at the judgment of other doctors
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If patients and guardians do not want to participate in this study
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History of having administered FGFR inhibitors in the past
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ho Kyung Seo
Investigators
- Principal Investigator: Ho Kyung Seo, MD, PhD, National Cancer Center, Korea
Study Documents (Full-Text)
None provided.More Information
Publications
- Cancer Genome Atlas Research Network. Comprehensive molecular characterization of urothelial bladder carcinoma. Nature. 2014 Mar 20;507(7492):315-22. doi: 10.1038/nature12965. Epub 2014 Jan 29.
- Loriot Y, Necchi A, Park SH, Garcia-Donas J, Huddart R, Burgess E, Fleming M, Rezazadeh A, Mellado B, Varlamov S, Joshi M, Duran I, Tagawa ST, Zakharia Y, Zhong B, Stuyckens K, Santiago-Walker A, De Porre P, O'Hagan A, Avadhani A, Siefker-Radtke AO; BLC2001 Study Group. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2019 Jul 25;381(4):338-348. doi: 10.1056/NEJMoa1817323.
- Wu YM, Su F, Kalyana-Sundaram S, Khazanov N, Ateeq B, Cao X, Lonigro RJ, Vats P, Wang R, Lin SF, Cheng AJ, Kunju LP, Siddiqui J, Tomlins SA, Wyngaard P, Sadis S, Roychowdhury S, Hussain MH, Feng FY, Zalupski MM, Talpaz M, Pienta KJ, Rhodes DR, Robinson DR, Chinnaiyan AM. Identification of targetable FGFR gene fusions in diverse cancers. Cancer Discov. 2013 Jun;3(6):636-47. doi: 10.1158/2159-8290.CD-13-0050. Epub 2013 Apr 4.
- U-FGFR