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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.
This study targets 92 patients with urothelial cancer, whose tissue (from scheduled surgery) and urine samples can be obtained, regardless of the treatment stage.
â– Examination Methods
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BC | Patients who were diagnosed with bladder cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FGFR test | Diagnostic Test | Detection of FGFR gene mutations in the tumor tissue and urine of patients |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Suspected patients of urothelial cancer who will visit the National Cancer Center Korea.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ho Kyung Seo, MD, PhD | Contact | +82-31-920-1678 | seohk@ncc.re.kr | |
| Sahyun Pak, MD | Contact | +82-31-920-2794 | sahyun@ncc.re.kr |
| Name | Affiliation | Role |
|---|---|---|
| Ho Kyung Seo, MD, PhD | National Cancer Center, Korea | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24476821 | Background | 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. | |
| 31340094 | Background | 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. |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
| 23558953 | Background | 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |