BRCA1 MutationBFORNCT03351803
BRCA Founder OutReach (BFOR) Study
An observational study of BRCA1 Mutation and BRCA2 Mutation, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- BRCA1 Mutation, BRCA2 Mutation
- What is being tested?
- BFOR Digital Health solution/Web Portal
- How many people
- 5,412 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Nov 2017to 10 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Self-reported age ≥ 25
- Self identify as having at least one of their four grandparents as Ashkenazi Jewish
- Has medical insurance
- Able to understand and read the English-language
- 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
Who cannot join
- Under age 25
- No Ashkenazi Jewish ancestry
- Does not have insurance
- Has previously had medical BRCA testing ordered by a health care provider
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of California, Los Angeles
Los Angeles, California, 90095
Memorial Sloan - Kettering Cancer Center
New York, New York, 10021
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
About this study
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.
- Conditions
- BRCA1 Mutation, BRCA2 Mutation
- Being tested
- BFOR Digital Health solution/Web Portal
- Keywords
- BRCA, BFOR, Ashkenazi, 17-568
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFOR Digital Health solution/Web PortalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Ashkenazi ancestry | Not described Receives: Other: BFOR Digital Health solution/Web Portal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of individuals receiving a standardized program of pretest education who then proceed to genetic testing
Measured: Up to 1 year
Proportions of individuals who choose to receive the results through their primary care providers or through the study-provided expert staff
Measured: Up to 1 year
Psychosocial impact of genetic population screening utilizing a digital health solution
Quality of life questionnaires measuring cancer-specific distress, perceived risk and BRCA 1/2 testing knowledge will be used.
Measured: Up to 1 year
Facilitators and barriers to engaging primary care providers (PCPs) in the BRCA1/2 results disclosure process
Post-disclosure PCP survey will be used to assess facilitators and barriers in the disclosure process
Measured: Up to 1 year
Participant health updates in personal familial cancer diagnosis and genetic testing depending on method of results communication
Written survey for health and diagnostic updates
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start10 Nov 2017
- Primary completion10 May 2027 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BRCA1 MutationStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, University of Pennsylvania, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Breast Cancer Research Foundation, Quest Diagnostics-Nichols Insitute, LIFELINK.COM INC, University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Kenneth Offit, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351803
- Sponsor's protocol ID
- 17-568
- Acronym
- BFOR
- Status last verified
- May 2026
- First submitted
- 14 Nov 2017
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34173196Pace 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.
PubMed 32807084
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRCA Founder OutReach (BFOR) Study
- ClinicalTrials.gov ID
- NCT03351803
- Acronym / sponsor ID
- BFOR / 17-568
- Conditions
- BRCA1 Mutation, BRCA2 Mutation
- Keywords
- BRCA, BFOR, Ashkenazi, 17-568
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,412 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, University of Pennsylvania, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Breast Cancer Research Foundation, Quest Diagnostics-Nichols Insitute, LIFELINK.COM INC, University of California, Los Angeles
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 10 May 2027 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Ashkenazi ancestry | – | Other: BFOR Digital Health solution/Web Portal |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Self-reported age ≥ 25
- Self identify as having at least one of their four grandparents as Ashkenazi Jewish
- Has medical insurance
- Able to understand and read the English-language
- 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
Key exclusion criteria (4 listed)
- Under age 25
- No Ashkenazi Jewish ancestry
- Does not have insurance
- Has previously had medical BRCA testing ordered by a health care provider
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BFOR Digital Health solution/Web PortalA 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. | Other | Participants with Ashkenazi ancestry |
Primary outcome
Proportion of individuals receiving a standardized program of pretest education who then proceed to genetic testing
Time frame: Up to 1 year
Proportions of individuals who choose to receive the results through their primary care providers or through the study-provided expert staff
Time frame: Up to 1 year
Psychosocial impact of genetic population screening utilizing a digital health solution
Time frame: Up to 1 year
Quality of life questionnaires measuring cancer-specific distress, perceived risk and BRCA 1/2 testing knowledge will be used.
Facilitators and barriers to engaging primary care providers (PCPs) in the BRCA1/2 results disclosure process
Time frame: Up to 1 year
Post-disclosure PCP survey will be used to assess facilitators and barriers in the disclosure process
Participant health updates in personal familial cancer diagnosis and genetic testing depending on method of results communication
Time frame: Up to 1 year
Written survey for health and diagnostic updates
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Derived from this study: PubMed 34173196Pace 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.
- Derived from this study: PubMed 32807084Pace 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.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Offit, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BRCA1 Mutation and BRCA2 Mutation, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of individuals receiving a standardized program of pretest education who then proceed to genetic testing (time frame: Up to 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03351803, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.