BRCA Founder OutReach (BFOR) Study

BRCA1 Mutation Clinical Trial

— BFOR  

Official title:

BRCA Founder OutReach (BFOR) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03351803
• Other study ID #: 17-568
• Status: Active, not recruiting
• Start date: November 10, 2017
• Est. completion date: May 10, 2024

Study information

• Verified date: June 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5412
• Est. completion date: May 10, 2024
• Est. primary completion date: May 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BRCA1 Mutation
• BRCA2 Mutation

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of California, Los Angeles	Los Angeles	California
United States	Memorial Sloan - Kettering Cancer Center	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (9)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of individuals receiving a standardized program of pretest education who then proceed to genetic testing		Up to 1 year
Primary	Proportions of individuals who choose to receive the results through their primary care providers or through the study-provided expert staff		Up to 1 year
Primary	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.	Up to 1 year
Primary	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	Up to 1 year
Primary	Participant health updates in personal familial cancer diagnosis and genetic testing depending on method of results communication	Written survey for health and diagnostic updates	Up to 1 year

External Links

•   Memorial Sloan Kettering Cancer Center