About this Study
- The study is sponsored by the National Cancer Institute
- This is an international study of women who are at increased
risk of ovarian cancer.
- After discussion with their own health care providers,
high-risk women will choose either risk-reducing surgery
or ovarian cancer screening.
- 2400 women will be enrolled in the screening portion of
the study and about 1000 women will be enrolled in the surgical
portion of this study.
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
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
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:
- 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
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
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.
The other group of women will be those who have chosen to have
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.