New research initiative
The BRCA Founder Outreach Study (BFOR) pioneers innovative model to increase access to BRCA genetic testing
BRCA genetic screening to be available for qualified women and men of Ashkenazi (Eastern European) Jewish ancestry in four major U.S. cities as part of first-of-its-kind trial using unique digital platform and partnership with primary care providers
A team of leading experts in the fields of cancer research and genetics will soon launch the pilot phase of a new, independent research initiative in New York, Los Angeles, Philadelphia, and Boston: the BRCA Founder Outreach Study (BFOR), which is designed to increase access to one of the most common tests for hereditary cancer. The website for the study, BFORstudy.com, is now open to those interested in participating, with potential enrollees to be contacted by email in the coming month when the study opens to accrual.
The study will offer BRCA genetic testing at no cost to participants for women and men of Ashkenazi (Eastern European) Jewish ancestry over the age of 25—a group that is ten times more likely than the general population to inherit certain kinds of BRCA mutations, which are associated with greater risks for several types of cancer, including breast, ovarian, and prostate cancers. BFOR will screen for specific ancestral-related (“founder”) mutations in BRCA1 or BRCA2 genes through Quest Diagnostics, the world’s largest provider of diagnostic information services. BFOR was initiated by a gift from the Sharon Levine Corzine Foundation and support from the Breast Cancer Research Foundation, with additional support as described at BFORstudy.com/support.
BFOR seeks to enroll a total of 4,000 individuals in its pilot study, with 1,000 participants in each of the four regions that are included in the pilot. A much larger BFOR study is anticipated to begin later in 2018.
“BFOR will equip patients, families, and their doctors with better information to make healthcare decisions based on their cancer risks,” said Dr. Kenneth Offit, a Principal Investigator of BFOR. “At the same time, it will provide a new model to increase access to genetic testing to optimize and personalize medical and preventive care.”
“The BFOR trial seeks to establish a better care management model that enables individuals with heightened risk to gain the genetic insights to take charge of their health.” said Yuri A. Fesko, MD, Medical Director, Oncology, Quest Diagnostics.
BFOR’s Principal Investigators have been at the forefront of the effort to identify genetic changes that cause cancer, and to develop approaches to early detection, prevention, and treatment, and include Dr. Kenneth Offit and Dr. Mark Robson of Memorial Sloan Kettering Cancer Center in New York; Dr. Judy Garber of the Dana Farber Cancer Institute and Dr. Nadine Tung of Beth Israel Deaconess Medical Center in Boston; Dr. Beth Karlan of Cedars-Sinai Medical Center in Los Angeles; and Dr. Susan Domchek and Dr. Katherine L. Nathanson of the Basser Center for BRCA at the Abramson Cancer Center of the University of Pennsylvania in Philadelphia.
“Up to half of BRCA carriers do not have a typical family cancer history that would alert them to their cancer risk. We hope that BFOR will make it easier for patients, families, and their doctors to make more informed healthcare decisions and reduce their cancer risks,” said Dr. Judy Garber, a Principal Investigator of BFOR.
“BRCA genetic testing has been available for more than 20 years. Although we know that testing can save lives, the significant majority of those at risk have not been screened,” said Dr. Nadine Tung, a Principal Investigator of BFOR. “We hope that BFOR will show that a web-based system can help to make testing more accessible. This will enable more people to benefit from their genetic information and take appropriate action to safeguard their health.”
The study will assess a new model for genetic testing. Built on the LifeLink.com conversational patient engagement platform, the study will provide pre-testing counseling and a unique partnership with primary care providers. Study participants will confirm their eligibility and register on their smartphone or computer, complete an online education module, provide their informed consent electronically, and have their lab test order sent directly to lab facilities in their community for the participant to supply a DNA sample at a Quest Diagnostics Patient Service Center. The participant’s primary care physician or a BFOR cancer genetics specialist will provide test results, follow-up genetic counseling and order additional genetic testing if appropriate. Intensive screening or risk-reducing surgery for those found to carry a BRCA mutation is covered by most health insurance.
“The study is a first-of-its-kind,” said Dr. Beth Karlan, a Principal Investigator of BFOR. “It combines access to experts on the BRCA gene, a state-of-the-art digital health platform, and educational and genetic counseling resources available to participants and their health care providers.”
“Because of the simplicity of testing for BRCA founder mutations, it makes sense to pilot this approach in those of Ashkenazi ancestry,” commented Dr. Susan Domchek, a Principal Investigator of BFOR. “If this model proves successful, it will have implications for testing for a variety of genetic predispositions in the general population.”
To help prepare for the pilot launch, BFOR conducted an extensive community outreach campaign to Jewish communities of all denominations and backgrounds.
To learn more, go to BFORStudy.com