Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-16 @ 12:37 PM
Study NCT ID:
NCT04242667
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2020-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Penn Biobank Return of Research Results Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-28', 'studyFirstSubmitDate': '2020-01-24', 'studyFirstSubmitQcDate': '2020-01-24', 'lastUpdatePostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of surveys', 'timeFrame': 'Baseline survey prior to disclosure of results, and then two post-disclosure surveys at 2-7 days and 6 months', 'description': 'Participant will self-complete surveys to collect psychological and knowledge outcomes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Cardiovascular Diseases', 'Hereditary Cancer', 'Hereditary Cardiac Amyloidosis']}, 'referencesModule': {'references': [{'pmid': '41241316', 'type': 'DERIVED', 'citation': 'Cocchella G, Phung L, Wood E, Egleston B, Hoffman-Andrews L, Brown S, Ofidis D, Mim R, Griffin H, Fetzer D, Owens A, Domchek S, Pyeritz R, Katona BW, Kallish S, Sirugo G, Weaver J, Nathanson KL, Rader DJ, Bradbury AR. An electronic review of clinical outcomes after return of actionable genetic research results from a health system research biobank. Eur J Med Genet. 2025 Dec;78:105061. doi: 10.1016/j.ejmg.2025.105061. Epub 2025 Nov 13.'}]}, 'descriptionModule': {'briefSummary': 'The overall goal of the proposed research is to assess the feasibility of a randomized study evaluating the non-inferiority of an electronic Health (e-Health) delivery alternative (e.g. private web portal) as compared to return of actionable genetic research results with a genetic counselor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Consented participant in University of Pennsylvania Biobank who previously submitted a DNA sample for research testing\n2. English speaking\n3. Aged 18 years or older\n4. Agreed to be re-contacted in the future or did not indicate a preference on future contact regarding research results\n5. Have an actionable mutation or have been selected as a control participant\n6. Have not previously received actionable results of clinical genetic testing\n\nExclusion Criteria:\n\n1. Deceased assessed by electronic medical record, death index or identified after contact\n2. Evidence in the electronic medical record that the subject has already received the same actionable result through clinical genetic testing'}, 'identificationModule': {'nctId': 'NCT04242667', 'briefTitle': 'Penn Biobank Return of Research Results Program', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'A Randomized Protocol Evaluating Return of Actionable Genetic Research Results to Biobank Participants', 'orgStudyIdInfo': {'id': 'UPCC 08021'}, 'secondaryIdInfos': [{'id': '833373', 'type': 'OTHER', 'domain': 'University of Pennsylvania IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Actionable gene result for cancer risk', 'interventionNames': ['Behavioral: e-Health (web-based) disclosure portal', 'Behavioral: Provider mediated disclosure']}, {'type': 'EXPERIMENTAL', 'label': 'Actionable gene result for cardiovascular disease risk', 'interventionNames': ['Behavioral: e-Health (web-based) disclosure portal', 'Behavioral: Provider mediated disclosure']}], 'interventions': [{'name': 'e-Health (web-based) disclosure portal', 'type': 'BEHAVIORAL', 'description': 'Patient uses secure web-based portal to access genetic research results', 'armGroupLabels': ['Actionable gene result for cancer risk', 'Actionable gene result for cardiovascular disease risk']}, {'name': 'Provider mediated disclosure', 'type': 'BEHAVIORAL', 'description': 'Patient has disclosure of genetic research result by a provider (genetic counselor)', 'armGroupLabels': ['Actionable gene result for cancer risk', 'Actionable gene result for cardiovascular disease risk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Angela Bradbury, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fox Chase Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}