Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-02 @ 1:59 AM
Study NCT ID:
NCT05467267
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2022-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Urine Biomarker for Patients With Bladder Cancer
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': 'Tumor DNA - extracted from Tumor tissue and the urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-17', 'studyFirstSubmitDate': '2022-02-21', 'studyFirstSubmitQcDate': '2022-07-17', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of somatic mutations in bladder tumor cells', 'timeFrame': '24 months', 'description': 'A set of selected somatic mutations will be checked against extracted urine cell free DNA from patients with bladder cancer, then a profile for each patient will be performed separately'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bladder neoplasm, urine, biomarker'], 'conditions': ['Bladder Neoplasm']}, 'descriptionModule': {'briefSummary': 'Introduction\n\nBladder cancer is the most common malignancy involving the urinary system and the ninth most common malignancy worldwide. Urothelial carcinoma is accounts for approximately 90 percent of bladder cancers in the western world.\n\nIn the United States, approximately 80,000 new cases and 17,000 deaths occur each year due to bladder cancer.\n\nApproximately 75% of patients present with superficial disease (Ta and T1), while 25% present with muscle invasive (T2 or greater) disease. Overall, 70% of treated tumors recur, with 30% of recurrent tumors progressing to muscle invasive disease.\n\nThe majority of these patients have a recurrence after endoscopic resection, thus lifelong surveillance with periodically cystoscopy is recommended. Cystoscopy, which is the "gold standard" for the detection of bladder cancer, is an expensive and invasive procedure, and it also can miss a flat lesion, especially carcinoma in situ which is considered a high grade malignant condition, therefore better follow-up tools should be developed in order to address those issues.\n\nVoided urinary cytology is a useful noninvasive adjunct to cystoscopy due to its high specificity, more than 90%. Although it has a high sensitivity at detecting high-grade lesions, between 80 to 90%,, in low-grade its sensitivity is very low, between 20 to 50%. Amongst the non-muscle-invasive, low grade tumors will progress to muscle-invasive or metastatic cancer at approximately 10% and roughly a third of high-grade tumors progress, therefore, close monitoring and early detection of all lesions are important for management, and noninvasive tumor markers with high accuracy for the detection of all grades of urothelial carcinoma will significantly reduce patient cost, anxiety and morbidity.\n\nCystoscopy in combination with cytology remains the most effective means of detecting bladder cancer. However, cystoscopy is an invasive procedure, and while cytology remains a useful method for detecting high grade tumors, its utility in detecting low grade tumors remains limited due to the lack of distinguishing cytological features between low grade disease and reactive processes. Currently there are several markers available or under investigation for the detection and monitoring/surveillance of bladder cancer, most of them have higher sensitivities, especially when used to identify low grade disease, but with lower specificities when compared to cytology. Furthermore, all of these tests must still be utilized in conjunction with cystoscopy findings.\n\nRecently, cell-free DNA (cfDNA) isolated from urine supernatant has been shown to have great potential in bladder cancer detection and surveillance. Bladder cancer exhibits unique genetic features that can be identified from sequencing and expression of cfDNA.\n\nAim of study:\n\nThe aim of this study is to establish a method for a personalized urinary biomarker with the usage of well explored urothelail cancer genetic mutations in urine cfDNA, for the detection of bladder cancer presence.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include 20 participants of patients with urothelial cancer of bladder who are planned for TURBT procedure.', 'genderDescription': 'Males', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18+ years old\n* Able to give a written consent\n* Able to provide a minimum of 60 mL of urine prior to undergoing transurethral resection of bladder tumor (TURBT)\n* Presence of a bladder tumor\n\nExclusion Criteria:\n\n* Active urinary infection\n* Macro-hematuria\n* Inadequate material for testing\n* Benign bladder tumor'}, 'identificationModule': {'nctId': 'NCT05467267', 'briefTitle': 'Personalized Urine Biomarker for Patients With Bladder Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ziv Hospital'}, 'officialTitle': 'Personalized Urine Biomarker for Patients With Bladder Cancer: Pilot Study', 'orgStudyIdInfo': {'id': '0121-21-ZIV'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TURBT', 'type': 'PROCEDURE', 'description': 'Patients with known bladder tumor undergoing TURBT - A biopsy from the tumor tissue will be taken. Peri operation a urine sample will be taken.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ran Katz, MD', 'role': 'CONTACT', 'email': 'rank@ziv.gov.il', 'phone': '+972-4-8629775'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziv Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}