Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-05 @ 6:08 PM
Study NCT ID:
NCT06304168
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2024-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2024-02-27', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall cancer (Y/N) - blood test', 'timeFrame': 'Baseline (samples collected at enrollment)', 'description': 'Blood samples will be assayed for known cancer markers to explore the potential value of a new blood test approach to detecting cancer. Accuracy of results may be evaluated based on review of past, present, and future medical record information.'}, {'measure': 'Overall cancer (Y/N) - urine test', 'timeFrame': 'Baseline (samples collected at enrollment)', 'description': 'Urine samples will be assayed for known cancer markers to explore the potential value of a new urine test approach to detecting cancer. Accuracy of results may be evaluated based on review of past, present, and future medical record information.'}, {'measure': 'Cancer specific site prediction - blood samples/MDM', 'timeFrame': 'Baseline (samples collected at enrollment)', 'description': 'Blood samples will be assayed for methylated DNA markers (MDMs) to identify individual organ sites of primary tumors.'}, {'measure': 'Cancer specific site prediction - urine samples/MDM', 'timeFrame': 'Baseline (samples collected at enrollment)', 'description': 'Urine samples will be assayed for methylated DNA markers (MDMs) to identify individual organ sites of primary tumors.'}, {'measure': 'Cancer specific site prediction - blood samples/RNA', 'timeFrame': 'Baseline (samples collected at enrollment)', 'description': 'Blood samples will be assayed for ribonucleic acid (RNA) to identify individual organ sites of primary tumors.'}, {'measure': 'Cancer specific site prediction - urine samples/RNA', 'timeFrame': 'Baseline (samples collected at enrollment)', 'description': 'Urine samples will be assayed for ribonucleic acid (RNA) to identify individual organ sites of primary tumors.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphatic System Neoplasm', 'Malignant Solid Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study explores the potential value of a new blood test approach for early detection of cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Validate candidate universal and site-specific MDMs in DNA extracted from formalin-fixed paraffin embedded primary tumor and control specimens.\n\nII. Test MDM-based models for detection of the top 16 most lethal human cancers using a non-invasive biological medium, specifically blood.\n\nIII. Assess feasibility for detection of cancers using urine samples to assay MDMs, RNA or protein in cell free or extra-cellular vesicles; patients may be the same or unique individuals from Aim 1 and 2.\n\nOUTLINE: This is an observational study.\n\nPatients undergo blood, urine, and/or residual tissue sample collection and have their medical records reviewed on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer and control patients who will be seen or treated at Mayo clinic.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aim 1 Tissue\n\n * Cases:\n\n * Patient has a biopsy confirmed diagnosis of target histology\n * Tissue samples from synchronous or metachronous primary cancers may be used as long as they are clearly of a different target organ.\n * Tumors from patients with an underlying genetic disorder pre-disposing to cancer may be included as long as they are stratified from those without\n * Controls:\n\n * Patient does not have the diagnosis of target histology\n* Aim 2 Blood\n\n * Cases:\n\n * Patient has a biopsy confirmed diagnosis of target histology or radiographic criteria that are unequivocal for diagnosis (example, meets radiographic criteria for hepatocellular carcinoma)\n * Controls:\n\n * Patient does not have a diagnosis of the target histology\n* Aim 3 Urine\n\n * Cases:\n\n * Patient has a biopsy confirmed diagnosis of target histology or radiographic criteria that are unequivocal for diagnosis (example, meets radiographic criteria for hepatocellular carcinoma)\n * Controls:\n\n * Patient does not have a diagnosis of the target histology\n\nExclusion Criteria:\n\n* Aim 1 Tissue\n\n * Cases and Controls:\n\n * Patient has had any transplants prior to tissue collection\n * Patient has received chemotherapy class drugs within 5 years prior to tissue collection\n * Cases:\n\n * Patient has had radiation to the current target lesion prior to tissue collection\n * Patient has multi-centric/multi-focal breast cancer with differing genetic profiles (ER/HER2/PR status differ; if multiple masses are present and not all are tested then exclude patient)\n * Patient has bilateral breast cancer/Ductal carcinoma in situ (DCIS)\n* Aim 2 Blood\n\n * Cases and Controls:\n\n * Patient has known cancer outside of the target cancer 5 years prior to blood collection (not including basal cell or squamous cell skin cancers)\n * Patient has received chemotherapy class drugs in the 5 years prior to blood collection\n * Patient has had any prior radiation therapy to the target lesion prior to blood collection\n * Patient has had a biopsy to the target organ and/or lesion within 3 days before blood collection\n * Cases:\n\n * Patient has had an intervention to completely remove current target pathology\n * The current target pathology is a recurrence\n * Patient has multi-centric/multi-focal breast cancer with differing genetic profiles (ER/HER2/PR status differ; if multiple masses are present and not all are tested then exclude patient)\n * Patient has bilateral breast cancer/DCIS\n* Aim 3 Urine\n\n * Patient has known cancer outside of the target cancer 5 years prior to urine collection (not including basal cell or squamous cell skin cancers)\n * Patient has received chemotherapy class drugs in the 5 years prior to urine collection\n * Patient has had any prior radiation therapy to the target lesion prior to urine collection\n * Patient has had a biopsy to the target organ and/or lesion within 3 days before urine collection\n * The current target pathology is a recurrence\n * Patient has chronic indwelling urinary catheter\n * Patient has had a urinary tract infection within the 14 days prior to sample collection\n * If patient does not have a primary bladder, ureter or urethral cancer, patient has a history of bladder ureter, or urethral cancer\n * Cases:\n\n * Patient has had an intervention to completely remove current target pathology\n * The current target pathology is a recurrence\n * Patient has multi-centric/multi-focal breast cancer with differing genetic profiles \\[estrogen receptor (ER)/human epidermal growth factor receptor 2 (HER2)/progesterone receptor (PR)\\] status differ; if multiple masses are present and not all are tested then exclude patient)\n * Patient has bilateral breast cancer/DCIS'}, 'identificationModule': {'nctId': 'NCT06304168', 'briefTitle': 'Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Validation of DNA Methylation Markers for the Universal and Site-Specific Guided Cancer Detection (the VANGUARD Study)', 'orgStudyIdInfo': {'id': '19-000890'}, 'secondaryIdInfos': [{'id': 'NCI-2024-00954', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '19-000890', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Patients undergo blood, urine, and/or residual tissue sample collection and have their medical records reviewed 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, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'John B. Kisiel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}