About this Study

Study Sponsor

The study is sponsored by the National Cancer Institute (NCI), and is being run by the Clinical Genetics Branch of NCI, in close collaboration with the Gynecologic Oncology Group and the Cancer Genetics Network.

Who May Benefit from this Study?

This is an international study of women who are at increased risk of ovarian cancer, either because they have a strong family history of breast and/or ovarian cancer or because they, or a close relative, have a mutation in the BRCA1 or BRCA2 genes.

Informed Choice

After discussion with their own health care providers, high-risk women participating in the study will choose either risk-reducing surgery or ovarian cancer screening. Both groups of women will be followed for 5 years. It is planned that about 1000 women will be enrolled in the surgical portion of this study, and that 2400 women will be enrolled in the screening portion of the study.

Women in the study can choose to be in one of two groups:

1. Screening Group:

   One group of women will have regular blood tests to measure the levels of a chemical in the body called CA-125. Doctors have found that checking CA-125 levels can help find a return of cancer in women who have had ovarian cancer in the past.

   In the current study, we are looking at a new way of using the CA-125 test to screen for ovarian cancer in women who are not known to have it. Instead of the current method of looking for ovarian cancer in women who have a single "higher-than-normal" CA-125 level (usually 35 IU/ml or greater), the new screening method is based on looking at changes in multiple CA-125 levels over time. This is done with a special computer program known as "ROCA," which stands for the Risk of Ovarian Cancer Algorithm.

   In the current research study, women found to have a rising trend in CA-125 over time will undergo additional studies to determine if they actually have ovarian cancer. It is hoped that this new way of using the CA-125 blood test will be more effective in finding early ovarian cancer. However, it is important to understand that this screening method has never been used before, and we do not know whether it will be an improvement over the current screening method or not.

2. Surgical Group:

   The other group of women will be those who have chosen to have their ovaries and fallopian tubes surgically removed to help prevent the development of ovarian and fallopian tube cancer. These women will be studied to determine by how much the surgery decreases the risk of ovarian, fallopian tube, and breast cancers. The tissue removed at surgery will also be studied to see whether a new way of examining the ovaries after they are removed provides better information about cancer-related tissue changes.

The choice regarding which study group each woman will join is made by the patient and her doctor, after reviewing the risks and benefits of the two different approaches to their care. If a woman chooses to enroll in the screening arm of GOG 0199, but later decides that she would prefer to have surgery, she is permitted to switch to the surgical arm of the study at that time.