BRCA Founder OutReach (BFOR) Study (BFOR)

May 26, 2026 updated by: Memorial Sloan Kettering Cancer Center
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5412

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan - Kettering Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Under age 25
  • No Ashkenazi Jewish ancestry
  • Does not have insurance
  • Has previously had medical BRCA testing ordered by a health care provider

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with Ashkenazi ancestry
Other: BFOR Digital Health solution/Web Portal
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of individuals receiving a standardized program of pretest education who then proceed to genetic testing
Time Frame: Up to 1 year
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
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.
Up to 1 year
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
Up to 1 year
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
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

University of Pennsylvania
University of California, Los Angeles
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Breast Cancer Research Foundation
Quest Diagnostics-Nichols Insitute
LIFELINK.COM INC

Investigators

  • Principal Investigator: Kenneth Offit, MD, MPH, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2017

Primary Completion (Estimated)

May 10, 2027

Study Completion (Estimated)

May 10, 2027

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

November 20, 2017

First Posted (Actual)

November 24, 2017

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17-568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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