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 Philadelphia, Boston, Los Angeles, and New York: the BRCA Founder Outreach Study (BFOR), which is designed to increase access to one of the most common tests for hereditary cancer. The study is now open to those interested in participating, with potential enrollees to be contacted by email soon.
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 the Breast Cancer Research Foundation, with additional supporters.
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 provide patients, families, and their doctors with better information to make important decisions about their health and help reduce their cancer risks,” said Dr. Susan Domchek, a Principal Investigator of BFOR and executive director of the Basser Center for BRCA at the Abramson Cancer Center of the University of Pennsylvania. “The study will also explore how our health care system can use genetic testing in new ways to improve and personalize medical care in the future.”
“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. 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; Dr. Judy Garber of the Dana Farber Cancer Institute and Dr. Nadine Tung of Beth Israel Deaconess Medical Center in Boston; Dr. Kenneth Offit and Dr. Mark Robson of Memorial Sloan Kettering Cancer Center in New York; and Dr. Beth Karlan of Cedars-Sinai Medical Center in Los Angeles.
“We know that BRCA genetic testing can save lives. Although this testing has been available for more than two decades, many people at high-risk for carrying a BRCA mutation have not been screened,” said Dr. Nathanson. “Many men and women in the Ashkenazi Jewish population who carry these mutations have not been identified.”
The study will assess a new model for genetic testing. Built on the LifeLink 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 brings together the convenience of direct-to-consumer genetic tests and the advantages of receiving health-related testing with the guidance of a medical care provider. BFOR has decided to pilot this approach in those of Ashkenazi ancestry due to the higher frequency of that mutation in this population, and the simplicity of the BRCA test. If the 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 has conducted an extensive community outreach campaign to Jewish communities of all denominations and backgrounds. Non-Ashkenazi Jews are encouraged to get tested as well.