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Active, Not Recruiting

NCT Number: NCT03351803

BRCA Founder OutReach (BFOR) 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

BRCA1 Mutation BRCA2 Mutation

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Los Angeles, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BFOR Digital Health solution/Web Portal

Other

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.

Primary outcomes

  1. Proportion of individuals receiving a standardized program of pretest education who then proceed to genetic testing

    Time frame: Up to 1 year

  2. 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

  3. 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.

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

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

Registry information

Acronym: BFOR

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Nov 24, 2017
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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