Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-02-28 @ 2:51 AM
Study NCT ID:
NCT03351803
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-03
First Post:
2017-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BRCA Founder OutReach (BFOR) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5412}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2017-11-14', 'studyFirstSubmitQcDate': '2017-11-20', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of individuals receiving a standardized program of pretest education who then proceed to genetic testing', 'timeFrame': 'Up to 1 year'}, {'measure': 'Proportions of individuals who choose to receive the results through their primary care providers or through the study-provided expert staff', 'timeFrame': 'Up to 1 year'}, {'measure': 'Psychosocial impact of genetic population screening utilizing a digital health solution', 'timeFrame': 'Up to 1 year', 'description': 'Quality of life questionnaires measuring cancer-specific distress, perceived risk and BRCA 1/2 testing knowledge will be used.'}, {'measure': 'Facilitators and barriers to engaging primary care providers (PCPs) in the BRCA1/2 results disclosure process', 'timeFrame': 'Up to 1 year', 'description': 'Post-disclosure PCP survey will be used to assess facilitators and barriers in the disclosure process'}, {'measure': 'Participant health updates in personal familial cancer diagnosis and genetic testing depending on method of results communication', 'timeFrame': 'Up to 1 year', 'description': 'Written survey for health and diagnostic updates'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BRCA', 'BFOR', 'Ashkenazi', '17-568'], 'conditions': ['BRCA1 Mutation', 'BRCA2 Mutation']}, 'referencesModule': {'references': [{'pmid': '34173196', 'type': 'DERIVED', 'citation': 'Pace LE, Tung N, Lee YS, Hamilton JG, Gabriel C, Revette A, Raja S, Jenkins C, Braswell A, Morgan K, Levin J, Block J, Domchek SM, Nathanson K, Symecko H, Spielman K, Karlan B, Kamara D, Lester J, Offit K, Garber JE, Keating NL. Challenges and Opportunities in Engaging Primary Care Providers in BRCA Testing: Results from the BFOR Study. J Gen Intern Med. 2022 Jun;37(8):1862-1869. doi: 10.1007/s11606-021-06970-8. Epub 2021 Jun 25.'}, {'pmid': '32807084', 'type': 'DERIVED', 'citation': 'Pace LE, Lee YS, Tung N, Hamilton JG, Gabriel C, Raja SC, Jenkins C, Braswell A, Domchek SM, Symecko H, Spielman K, Karlan BY, Lester J, Kamara D, Levin J, Morgan K, Offit K, Garber J, Keating NL. Comparison of up-front cash cards and checks as incentives for participation in a clinician survey: a study within a trial. BMC Med Res Methodol. 2020 Aug 17;20(1):210. doi: 10.1186/s12874-020-01086-9.'}], 'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to learn how to provide BRCA gene testing to a larger number of people as well as to make testing part of a person's regular medical care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be invited to join the BFOR study through information provided to their PCPs by the testing laboratories, and media and community outreach. The study will also be promoted through search engines and by genetics providers who are aware of the study. Approach to the study will be entirely participant-initiated and controlled.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-reported age ≥ 25\n* Self identify as having at least one of their four grandparents as Ashkenazi Jewish\n* Has medical insurance\n* Able to understand and read the English-language\n* Zip code falls within the catchment areas of the phase of the study (e.g. New York City, Boston, Philadelphia, Los Angeles) accessible to a BFOR designated provider\n\nExclusion Criteria:\n\n* Under age 25\n* No Ashkenazi Jewish ancestry\n* Does not have insurance\n* Has previously had medical BRCA testing ordered by a health care provider'}, 'identificationModule': {'nctId': 'NCT03351803', 'acronym': 'BFOR', 'briefTitle': 'BRCA Founder OutReach (BFOR) Study', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'BRCA Founder OutReach (BFOR) Study', 'orgStudyIdInfo': {'id': '17-568'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with Ashkenazi ancestry', 'interventionNames': ['Other: BFOR Digital Health solution/Web Portal']}], 'interventions': [{'name': 'BFOR Digital Health solution/Web Portal', 'type': 'OTHER', 'description': "A digital health solution with Internet-based participant recruitment and ascertainment is a mechanism for distributing access to genetic testing to populations who might not otherwise have access. For this project, LifeLink will build a private web-portal designed by the PI's of the study as described in this protocol, including the wireframes that are in the appendices, that will enable secure contact between study participants and the participating commercial laboratory (Quest Diagnostics) and BFOR researchers, as well as facilitate contacts between study participants and their primary care providers and/or a list of BFOR study centers and BFOR providers.", 'armGroupLabels': ['Participants with Ashkenazi ancestry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan - Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104-4283', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Kenneth Offit, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Breast Cancer Research Foundation', 'class': 'OTHER'}, {'name': 'Quest Diagnostics-Nichols Insitute', 'class': 'INDUSTRY'}, {'name': 'LIFELINK.COM INC', 'class': 'UNKNOWN'}, {'name': 'University of California, Los Angeles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}