FAQ

 

About the Breast Cancer Family Registry

 

1.   What is the Breast Cancer Family Registry all about?

 

  • The Breast Cancer Family Registry (BCFR) is a large cohort study of families who are at increased risk of breast and ovarian cancer based on family history or genetic mutations.  The study is based at 6 research sites: Stanford University in Stanford, CA, Columbia University in New York, NY, Fox Chase Cancer Center in Philadelphia, PA, Huntsman Cancer Institute in Salt Lake City, UT, Mt. Sinai Medical Center in Ontario, Canada, and The University of Melbourne in Melbourne, Australia. This important study is funded by the National Cancer Institute (NCI), one of the National Institutes of Health. The study follows approximately 30,000 individuals from nearly 12,000 families by administering questionnaires and collecting biospecimens and pathology information.

 

2.   What will the Breast Cancer Family Registry Study tell us?

 

  • Researchers believe the BCFR will help us better understand reasons why women get breast cancer, especially reasons that concern increased risk within families. Results from the BCFR may also help us understand how genes interact with the environment and how risk factors may vary for the different subtypes of breast cancer. Knowledge gained from the BCFR will be used to develop recommendations for preventing breast cancer in the future and promoting good health for families at increased risk of breast cancer.

 

3.   Who is running the study?

 

  • The Principal Investigators at each BCFR site are:
    • Esther John, PhD, Stanford University in Stanford, CA
    • Mary Beth Terry, PhD, Columbia University in New York, NY
    • Mary Daly, MD, PhD, Fox Chase Cancer Center in Philadelphia, PA
    • Saundra Buys, MD, Huntsman Cancer Institute in Salt Lake City, UT
    • Irene Andrulis, PhD, Samuel Lunenfeld Research Institute of Mt. Sinai Medical Center in Ontario, Canada
    • John Hopper, PhD, The University of Melbourne in Melbourne, Australia
    • Learn more about the Investigators leading the study by visiting Participating Sites.

 

4.    Why is it important for me to continue to help the Breast Cancer Family Registry?

 

  • Our understanding of breast cancer continues to develop. The family-based design of this study helps us to understand hereditary components contributing to risk of breast cancer. A major strength of the BCFR is that we continue to collect data from the same families and individuals over time. This is important for research because it allows us to examine how certain factors may affect risk throughout the different stages of one’s life. It is important for us to hear from you when there has been a new diagnosis of cancer for you or your family members, but it is also important for us to know when there haven’t been significant changes by completing our regular questionnaires and interviews.

 

5.    How will the information learned from the Breast Cancer Family Registry be used to benefit public health?

 

  • The information collected in the BCFR is used to identify risk factors that may increase a woman’s the chances of developing breast cancer. The results have been and will continue to be published in scientific literature, including journals read by physicians, epidemiologists, and laboratory scientists. By providing this information to the science community and the public, guidelines for prevention and reducing one’s risk can be based on research data from families with an increased risk of breast cancer, in addition to information available to those in the general population that have an average risk.

 

6.   Why does this study focus on families with breast cancer, instead of individuals?

 

  • By studying families we can gain insight into genetic and environmental factors that are shared at the family level rather than the individual level.  In addition, risk for each participant can be categorized not only by the presence or absence of a family history of breast cancer, but also by an estimated Familial Risk Profile, based on multigenerational family history data and genetic data. Researchers can utilize the Familial Risk Profile to develop risk prediction models that clinicians can utilize to help guide patients from high-risk families regarding screening and treatment decisions.

 

7.  Who makes sure this study is safe and scientifically sound?

 

  • Research funded by the U.S. government, like the BCFR, is carefully reviewed and monitored.  Each of the six research sites involved has an Institutional Review Board (IRB) that reviews the study protocol and questionnaires, identifying issues and concerns, and works with the investigators as needed to improve the study. The IRB at each site is diverse and includes ethicists, lawyers, physicians, scientists and community members. The investigators and staff who are conducting the study receive ongoing monitoring and education to ensure that these requirements are fulfilled.

 

Study participation

1.   Who can participate in the Breast Cancer Family Registry?

  • We have Breast Cancer Family Registry sites in the U.S. (New York City, Philadelphia, Salt Lake City, San Francisco Bay Area); Ontario, Canada; and Melbourne, Australia that recruited and followed families that have a family history of breast cancer or carry mutations in either the BRCA1 or BRCA2 gene. We are currently expanding the BCFR Cohort by inviting additional family members to participate. We would like to include adults (18 years or older) who have a first-degree relative that is affected with breast cancer. This could be someone’s sister, brother, parent or child. Please contact specific sites for information if you are interested. Please contact your local research site if you or one of your family members would like to join the BCFR (Participating Sites).

2.    What does participation in the Breast Cancer Family Registry involve?

  • At initial enrollment, we will send you a consent form discussing all the details about participation for you to review and sign, and a personal history questionnaire asking about health history, lifestyle habits, and demographic information. We will also ask for a blood or saliva sample.
  • We follow-up with all our participants through our annual mailings, or follow-up questionnaires for any health status changes and up to date information on screening, pregnancies and lifestyle habits. You can also contact us if you want to report any changes. This will help us learn about how changes in lifestyle habits, or other health related factors may affect breast and ovarian cancer risk.
  • If anyone reports a new or recurrent breast or ovarian cancer, we will contact you for information on treatment, and permission to obtain pathology reports and tumor samples from your clinician for more details on your diagnosis

3.    Will my information be kept confidential? How will this be done?

  • We have put in place several protections for the privacy of your data. When your data are collected, they are labeled with a unique identification (ID) number. After your data are collected, your biospecimen samples, questionnaires, and interview data are stored separately from any personal identifiers, such as your name, address, and phone number. Your personal contact information is kept in separate files available only to the research staff at the specific site where you participate.  When data are used for analysis, the only identifier available to researchers is the randomly assigned numeric ID.
  • Each site of the BCFR has received a Certificate of Confidentiality that helps us protect the confidentiality of your data against compulsory legal demands (e.g., court orders and subpoenas) that seek the name or other identifying characteristics of a research subject. With a Certificate of Confidentiality, researchers cannot be forced by anyone to give out information that could identify you.

4.    Does the Breast Cancer Family Registry provide BRCA testing?

  • Not all sites of the BCFR conducted BRCA testing on samples from their research participants.  Those sites that did conduct BRCA testing in the past are no longer providing genetic testing for participants.
  • For participants who did get clinical BRCA testing done with us in the past: if you are interested in obtaining results, or have any questions please contact your research site for more information by going to Participating Sites.

5.   Will I receive results from the study?

  •  Though we cannot provide individual results, we can provide results from general studies on all participants in the BCFR. Over the years, our participants have helped us make major advances in learning how to reduce breast and ovarian cancer risk. You can find more information on published research studies by going to Publication Highlights or Publications by Year.

6.    What if I no longer want to participate?

  • You can withdraw from the BCFR at any time. If you are no longer interested in participating, please contact the research site where you participate.  You can find the contact information at your research site by going to Participating Sites.

Also on the BCFR Website:

Ongoing Grants

Find out more about our ongoing studies, such as the ProF-SC grant.

Publications

Read highlights from recent publications utilizing BCFR data.

Initiating Collaborations

If you would like to utilize data from the BCFR, please read our data sharing policies and contact us to initiate this process.