What to Expect

If you join the study, you will be asked to do the following:

• Choose the study group you prefer. This will be done after discussing the risks and benefits of surgery and screening with your health care providers.
• Fill out forms. At the first visit, you will fill out forms about your personal health, your family's medical history, and your quality of life. At follow-up visits, you will fill out a shorter form about any changes in your health, your family's health related to cancer, and your quality of life.
• Assist the researchers in learning your BRCA1/BRCA2 mutation status. It is essential to the study for researchers to know whether each study participant has a BRCA1/BRCA2 mutation or not.
  • If you already know your mutation status, the investigators will request that you provide a copy of the mutation test report.
  • If you have chosen not to know your mutation status, research testing will be done on the blood sample that you provide at the time of study entry. The results of this testing, which will be done for research purposes, will not be routinely disclosed to study participants. This information will be kept in strictly confidential, coded, password-protected files.
  • It is not the intention of this study to provide BRCA mutation testing for clinical purposes or for use in making decisions regarding whether to be screened or to have surgery. If you wish to know your mutation status prior to deciding which part of the study to join - and we recommend that women planning surgery learn their mutation status first - that testing will need to be done prior to entering this study. If you have not been tested for BRCA mutations, and if you are interested in doing so before entering the study, please ask your doctor to help you arrange for genetic counseling and testing.
  • Continue to get your regular medical care. Women at increased genetic risk of ovarian cancer are also at increased risk of breast cancer. You will continue to receive routine mammograms at least once yearly, under the supervision of your regular health care providers. Women who undergo surgery will enter menopause at an earlier-than-usual age. Health care guidelines related to early menopause will be provided.

If you are in the screening group, you will also be asked to:

• Give a blood sample. At the beginning of the study, and every three months for 5 years thereafter, you will have a small amount of blood taken from your arm. Doctors will look at the amount of CA-125 in your blood. Blood samples will be saved for future research related to familial ovarian/breast cancer.
• Have a transvaginal ovarian ultrasound. Each participant in the screening group of the study will have a transvaginal ovarian ultrasound done at the beginning of the study, and once a year thereafter. In addition, some women may be asked to get an extra ultrasound examination if the CA-125 blood test is abnormal. This is currently considered the standard way to monitor women at increased genetic risk for the development of ovarian cancer.

If you are in the surgical group, you will also be asked to:

• Undergo surgery if you have chosen to participate in the surgical group of the study. Both the ovaries and the fallopian tubes will be removed. The tissue removed at the time of surgery will be reviewed by the study pathologists after the pathologists at your hospital have completed their evaluation. Small portions of normal ovarian and fallopian tube tissue will be frozen and stored for future research related to familial breast/ovarian cancer. If a tumor is found at the time of surgery, a small portion of tumor tissue will also be stored.
• Have a transvaginal ovarian ultrasound. Each participant in the surgical group of the study will have a transvaginal ovarian ultrasound done at the beginning of the study only. Once the ovaries have been removed, transvaginal ultrasound is no longer required.
• Give a blood sample. At the beginning of the study, and every 6 months for 5 years thereafter, you will have a small amount of blood taken from your arm. Doctors will look at the amount of CA-125 in your blood. Blood samples will be saved for future research related to familial ovarian/breast cancer.