Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT06456320
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-16
First Post:
2024-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mayo Clinic Tapestry 2.0: Applying Multi-Omics for Scientific Discovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}], 'ancestors': [{'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool, urine, saliva, plasma, white blood cells (WBC), peripheral blood mononuclear cells (PBMC), whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2024-06-07', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Creation of a unique integrated asset of multi-omics data', 'timeFrame': 'Up to 5 years', 'description': 'A variety of patient cohorts will be ascertained throughout this study. Data will be made available to researchers to query correlations of disease states and clinical outcomes to multi-omics findings. These insights will be invaluable to creating omics-informed care plans in the future. Standard descriptive statistics approaches will be used for analysis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Genetic Predisposition', 'Exposure, Environmental']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to use multi-omics testing on samples collected from Mayo Clinic patients to build and expand on what has been learned about genomic data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mayo Clinic patients', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Registered Mayo Clinic patient\n* Able to provide informed written consent\n* Able to receive mail and packages within a United States (US) state\n* Able to collect and ship samples within a US state\n\nExclusion Criteria:\n\n* Active hematological cancer or history of a hematological cancer\n* Allogeneic Bone Marrow Transplant (e.g., samples from autologous bone marrow transplant recipients are acceptable if collected at least one month after transplant)\n* Other co-morbidity that, in physician's opinion, would interfere with patient's ability to participate in the study (e.g., reduced ability to comprehend, i.e., dementia, intellectual disability, etc.)"}, 'identificationModule': {'nctId': 'NCT06456320', 'briefTitle': 'Mayo Clinic Tapestry 2.0: Applying Multi-Omics for Scientific Discovery', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Mayo Clinic Tapestry 2.0: Applying Multi-Omics for Scientific Discovery', 'orgStudyIdInfo': {'id': '23-004120'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Suspected Genetic Predisposition or Multi-Omics Contribution', 'description': 'Patients with a diagnosis or phenotype with the potential for association with a genetic predisposition or Multi-Omics Contribution.'}, {'label': 'Healthy Control', 'description': 'Patients with no diagnosis associated with a genetic predisposition or Multi-Omics Contribution.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Konstantinos N. Lazaridis, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive Director, Center for Individualized Medicine', 'investigatorFullName': 'Konstantinos N. Lazaridis, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}