Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2026-01-02 @ 3:23 AM
Study NCT ID:
NCT06109857
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2023-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bladder Bank (a Prospective Banking Study)
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_WITHOUT_DNA', 'description': 'Blood Collection: At study enrollment for subjects, 60 ml (4 tablespoons) of blood will be drawn from all participants and will be processed according to standardized study biospecimen protocol. Specimens will be stored in a secure lab for future approved research.\n\nUrine Collection: At study enrollment for subjects, up to 20mL of urine in 5 ml aliquots (stored with or without fixative in up to 5 equal aliquots) from the same or unique case patients above targeted for blood collection.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood sample to support the development of non-invasive tests for early detection of bladder cancer', 'timeFrame': 'Baseline (at enrollment)', 'description': 'At study enrollment for subjects, 60 ml (4 tablespoons) of blood will be drawn from all participants and processed according to standardized study biospecimen protocol. All samples will be stored for future analysis in Molecular Cancer Diagnostic Laboratory at Mayo Clinic.'}, {'measure': 'Urine sample to support the development of non-invasive tests for early detection of bladder cancer', 'timeFrame': 'Baseline (at enrollment)', 'description': 'At study enrollment for subjects, up to 20mL of urine will be collected from the same or unique case patients identified for blood collection. All samples will be stored for future analysis in Molecular Cancer Diagnostic Laboratory at Mayo Clinic.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study collects blood and urine samples from patients with bladder cancer to support the development of tests for early detection of bladder cancer.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To establish a biobank of samples (blood and urine) to support the development of non-invasive tests for early detection of bladder cancer.\n\nOUTLINE: This is an observational study.\n\nPatients undergo blood and urine sample collection and have their medical records reviewed while on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient has undergone office-based evaluation for hematuria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Patient has undergone office-based evaluation for hematuria \\[computed tomography (CT), ultrasound, cystoscopy\\]\n\nExclusion Criteria:\n\n* Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible)\n* Patient has recurrent muscle invasive bladder cancer\n* Patient has ever been previously diagnosed with UTUC (upper tract urothelial carcinoma) prior to bladder resection\n* Patient has received chemotherapy class drugs for the treatment of non-target origin cancer in the 5 years prior to current collection\n* Patient has had any prior radiation therapy to the target lesion prior to current collection\n* Patient has had a biopsy to the target organ and/or lesion within 3 days before collection\n* Patient has undergone cystectomy or cystoprostatectomy\n* Patient has transurethral instrumentation (placement of urinary catheter) within 7 days prior to urine collection\n* Patient has had a urinary tract infection within 14 days prior to urine collection\n* Patient has chronic indwelling urinary catheter'}, 'identificationModule': {'nctId': 'NCT06109857', 'briefTitle': 'Bladder Bank (a Prospective Banking Study)', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Bladder Bank (a Prospective Banking Study)', 'orgStudyIdInfo': {'id': '21-009854'}, 'secondaryIdInfos': [{'id': 'NCI-2023-00644', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '21-009854', 'type': 'OTHER', 'domain': 'Mayo Clinic in Rochester'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Patients undergo blood and urine sample collection and have their medical records reviewed while on study.', 'interventionNames': ['Other: Non-Interventional Study']}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'description': 'Non-interventional study', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'John B. Kisiel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}], 'overallOfficials': [{'name': 'John B. Kisiel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}