Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-30 @ 4:17 AM
Study NCT ID:
NCT05982561
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2023-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2023-07-27', 'studyFirstSubmitQcDate': '2023-08-06', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of BCDx (the proportion of negatives that are correctly identified as such by the gold standard)', 'timeFrame': "Participants' urine samples will be collected before cystoscopy and analyzed using the BCDx test within 6 months to establish its overall performance characteristics."}]}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'BCDx is a urine-based multi-omic assay for early cancer recurrence detection in patients with a history of bladder cancer. This prospective, blinded study evaluates its efficacy in detecting recurrent NMIBC, offering a noninvasive monitoring solution.', 'detailedDescription': 'BCDx is a urine-based multi-omic/multiplex molecular assay offers a promising solution for detecting cancer recurrence. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer. This is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel multi-omics test for the detection of recurrent NMIBC in patients with a history of bladder cancer undergoing surveillance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cystoscopic surveillance for non-muscle invasive bladder cancer (NMIBC) follow-up.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 Years and older\n* Patients who have been diagnosed with incident or recurrent NMIBC within the past 2 years and undergoing standard of care/routine monitoring cystoscopy.\n* Patients who are able to provide legally effective informed consent.\n* Patients who are able to provide minimum 30mL of voided urine.\n\nExclusion Criteria:\n\n* Patients planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma.'}, 'identificationModule': {'nctId': 'NCT05982561', 'briefTitle': 'Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Early is Good Inc.'}, 'officialTitle': 'Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer', 'orgStudyIdInfo': {'id': 'EIG 2023-02'}}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marotte,', 'role': 'CONTACT'}, {'name': 'Jeff Marotte, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arkansas Urology Research Center', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hristos Kaimakliotis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '63130', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zeynep G. Gul, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Thakshila Liyanage, PhD', 'role': 'CONTACT', 'email': 'thakshila@earlyisgood.com', 'phone': '(317) 941-6953'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Early is Good Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}