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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04339933
• Other study ID #: U-FGFR
• Status: Not yet recruiting
• Start date: May 1, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2022
• Source: National Cancer Center, Korea
• Contact: Ho Kyung Seo, MD, PhD
• Phone: +82-31-920-1678
• Email: seohk[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 92
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell

Intervention

Diagnostic Test:
• FGFR test
Detection of FGFR gene mutations in the tumor tissue and urine of patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ho Kyung Seo

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Patient prognosis	recurrence-free	six months and one year after treatment
Secondary	Patient prognosis	progression-free	six months and one year after treatment
Secondary	Patient prognosis	cancer-specific survivals	six months and one year after treatment
Secondary	Patient prognosis	overall survivals	six months and one year after treatment
Secondary	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