Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-01-04 @ 4:46 PM
Study NCT ID:
NCT04339933
Status:
UNKNOWN
Last Update Posted:
2022-04-07
First Post:
2020-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of FGFR Gene Mutations in the Tumor Tissue and Urine of Patients With Urothelial Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Study samples (8 ml blood and 20 ml urine) will be collected once within one month before treatment and once within three months after treatment, from the subjects who will agree to participate in the study.\n* Additional study samples will be collected once (8 ml blood and 20 ml urine) after surgery (or neoadjuvant chemotherapy).\n* Tissue samples will be collected during transurethral resection of bladder tumor (TUR-BT) before BCG therapy or after TUR-BT and cystectomy before and after neoadjuvant chemotherapy.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2020-04-07', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'The ratio of patients with matching test results to total patients'}], 'secondaryOutcomes': [{'measure': 'Changes in FGFR mutations in tissues before and after treatment', 'timeFrame': 'Up to two weeks before and after treatment', 'description': '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.'}, {'measure': 'Patient prognosis', 'timeFrame': 'six months and one year after treatment', 'description': 'recurrence-free'}, {'measure': 'Patient prognosis', 'timeFrame': 'six months and one year after treatment', 'description': 'progression-free'}, {'measure': 'Patient prognosis', 'timeFrame': 'six months and one year after treatment', 'description': 'cancer-specific survivals'}, {'measure': 'Patient prognosis', 'timeFrame': 'six months and one year after treatment', 'description': 'overall survivals'}, {'measure': 'PD-L1 expression', 'timeFrame': 'Up to two weeks before and after treatment', 'description': 'PD-L1 expression level will be measured using immunohistochemistry, RNA sequencing, and other suitable methods to analyze the bladder cancer subtypes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '24476821', 'type': 'BACKGROUND', '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.'}, {'pmid': '31340094', 'type': 'BACKGROUND', '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."}, {'pmid': '23558953', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This study targets 92 patients with urothelial cancer, whose tissue (from scheduled surgery) and urine samples can be obtained, regardless of the treatment stage.\n\n■ Examination Methods\n\n* FGFR mutations in bladder cancer tissues will be analyzed using next-generation sequencing and current companion diagnostic methods.\n* FGFR mutations in urine samples obtained from patients with bladder cancer will be analyzed using nanowires.\n* Bladder cancer subtyping will be performed by RNA sequencing of tumor tissues or other methods.\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Suspected patients of urothelial cancer who will visit the National Cancer Center Korea.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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\n\nExclusion Criteria:\n\n* History of other active malignant tumors treated within 24 months\n* Patients with either mental illness or who cannot participate in clinical trials at the judgment of other doctors\n* If patients and guardians do not want to participate in this study\n* History of having administered FGFR inhibitors in the past'}, 'identificationModule': {'nctId': 'NCT04339933', 'briefTitle': 'Detection of FGFR Gene Mutations in the Tumor Tissue and Urine of Patients With Urothelial Carcinoma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'Detection of FGFR Gene Mutations in the Tumor Tissue and Urine of Patients With Urothelial Carcinoma', 'orgStudyIdInfo': {'id': 'U-FGFR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BC', 'description': 'Patients who were diagnosed with bladder cancer', 'interventionNames': ['Diagnostic Test: FGFR test']}], 'interventions': [{'name': 'FGFR test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Detection of FGFR gene mutations in the tumor tissue and urine of patients', 'armGroupLabels': ['BC']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ho Kyung Seo, MD, PhD', 'role': 'CONTACT', 'email': 'seohk@ncc.re.kr', 'phone': '+82-31-920-1678'}, {'name': 'Sahyun Pak, MD', 'role': 'CONTACT', 'email': 'sahyun@ncc.re.kr', 'phone': '+82-31-920-2794'}], 'overallOfficials': [{'name': 'Ho Kyung Seo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center, Korea'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ho Kyung Seo', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Scientist', 'investigatorFullName': 'Ho Kyung Seo', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}