Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT05298904
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-18
First Post:
2022-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pro-active Genetic Testing in Kidney Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Participants will be asked to provide a blood sample. Participants may be asked to provide an additional research blood sample for biobanking purposes, up to 40mL of blood per subject .'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2038-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-15', 'studyFirstSubmitDate': '2022-03-11', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2037-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Genetic mutations of cardiomyopathy', 'timeFrame': '1 year', 'description': 'Prevalence of genetic mutations for cardiomyopathies in kidney transplant recipients'}], 'primaryOutcomes': [{'measure': 'Genetic mutations of cancer', 'timeFrame': '1 year', 'description': 'Number of subjects to have genetic mutations of cancer in kidney transplant patients receiving care at Mayo Clinic Arizona'}], 'secondaryOutcomes': [{'measure': 'The impact of genetic testing', 'timeFrame': '1 Year', 'description': "Current guidelines for cancer screening have limitations, as its mostly age based. Immunosuppression can lead to a increased risk of cancer in the kidney transplant population.\n\nBy utilizing a multi gene panel we'll look for the number subjects with positive findings and see how recommendations of care change vs standard of care as recommended by the National Comprehensive Cancer Network (NCCN). Genetic testing and family history may change the practice regarding cancer screening in subjects undergoing kidney transplant evaluation."}, {'measure': 'Develop a Biorepository', 'timeFrame': '1 year', 'description': 'Create a biorepository based on whole exome sequencing and clinical data for future analysis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplant']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the prevalence of genetic mutations that increase the risk of cancer and other medically actionable diseases in kidney transplant patients and to assess the impact of genetic testing on subsequent surveillance for cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be identified internally to Mayo Clinic Arizona via the kidney transplant program within one-year post transplant.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Post transplant Kidney and Kidney Pancreas recipients.\n\nExclusion Criteria:\n\n* Simultaneous Liver Kidney Transplant.\n* Simultaneous Heart Kidney Transplant.\n* Non renal transplant history.'}, 'identificationModule': {'nctId': 'NCT05298904', 'briefTitle': 'Pro-active Genetic Testing in Kidney Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Pro-active Genetic Testing in Kidney Transplant Patients', 'orgStudyIdInfo': {'id': '21-009697'}, 'secondaryIdInfos': [{'id': 'NCI-2022-02382', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trials Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Kidney Transplants', 'description': 'Kidney transplant patients who are within one-year post transplant.', 'interventionNames': ['Diagnostic Test: Genetic Health Screen Panel']}], 'interventions': [{'name': 'Genetic Health Screen Panel', 'type': 'DIAGNOSTIC_TEST', 'description': 'This panel covers cardiomyopathy genes, and cancer genes. The results of this panel are reported as Positive (pathogenic or likely pathogenic mutation identified in one or more genes) or Negative (no pathogenic/likely pathogenic mutations identified).', 'armGroupLabels': ['Kidney Transplants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Girish Mour, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Girish K. Mour', 'investigatorAffiliation': 'Mayo Clinic'}}}}