Clinical trial NCT04339933: Detection of FGFR Gene Mutations in the Tumor Tissue and Urine of Patients With Urothelial Carcinoma
Official title: Detection of FGFR Gene Mutations in the Tumor Tissue and Urine of Patients With Urothelial Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2020-04-09
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Suspected patients of urothelial cancer who will visit the National Cancer Center Korea.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between FGFR mutations found in bladder cancer tissues and urine before and after treatment
timeFrame: Up to two weeks before and after surgery
Secondary outcomes:
measure: Changes in FGFR mutations in tissues before and after treatment
timeFrame: Up to two weeks before and after treatment
measure: Patient prognosis
timeFrame: six months and one year after treatment
measure: Patient prognosis
timeFrame: six months and one year after treatment
measure: Patient prognosis
timeFrame: six months and one year after treatment
measure: Patient prognosis
timeFrame: six months and one year after treatment
measure: PD-L1 expression
timeFrame: Up to two weeks before and after treatment
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Center, Korea
name: Ho Kyung Seo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.