Inclusion Criteria

- INCLUSION CRITERIA:

To be considered at increased genetic risk of OC, subjects must have:

Age greater than or equal to 30;

No prior history of OC, including low malignant potential cancers (LMP), or primary
papillary serous carcinoma of the peritoneum;

At least one intact ovary:

Satisfied one of the following additional criteria:

The family of the subject has a documented deleterious BRCA1 or BRCA2 mutation - either:

- the subject herself has tested positive for a deleterious BRCA1 or BRCA2 mutation;
OR

- the subject has a first- or second-degree relative with a deleterious BRCA1 or BRCA2
mutation

OR

The family contains at least two ovarian and/or breast cancers among the subject or first-
or second-degree relatives of the subject within the same lineage. This condition is
satisfied by multiple primary cancers in the same person. Where breast cancer is required
to meet this criterion, at least one breast cancer must have been diagnosed prior to
menopause (age at diagnosis less than or equal to 50 if age at menopause is unknown); OR

The subject is of Ashkenazi Jewish ethnicity with one first-degree or two second-degree
relatives with breast and/or OC. Where breast cancer is required to meet this criterion,
at least one case must have been diagnosed prior to menopause (or at age less than or
equal to 50, if age at menopause is unknown).

OR

The subject is of Ashkenazi ancestry and has had breast cancer herself. To meet this
criterion, her breast cancer must have been diagnosed prior to menopause (age at diagnosis
less than or equal to 50 if age at menopause is unknown).

OR

The probability of carrying a BRCA1/2 mutation given the family pedigree of breast and OCs
exceeds 20% as calculated by BRCAPRO.

Note: BRCAPRO does NOT need to be calculated on everyone who enters the study. Patients
are eligible based on a family history which meets one of the specific patterns described
in this protocol, regardless of BRCAPRO results. BRCAPRO assessment is valuable in
families where genetic testing has not been done, and the family history does not fit one
of the specific patterns described, but the pattern of cancers leads you to believe that
the family might still be considered high-risk. At that point, if the BRCAPRO estimate of
being a mutation carrier is greater than 20 percent, then the patient IS eligible.

Signed an approved informed consent and authorization permitting release of personal
health information.

EXCLUSION CRITERIA:

A first- or second-degree relative has a deleterious BRCA1/2 mutation, and the subject has
tested NEGATIVE for the exact same mutation.

Women who are currently pregnant or planning pregnancy during the study.

Women who are participating in another OC early detection trial (except for the ROCA study
being run by the Cancer Genetics Network. Women who have enrolled in the ROCA study and
who subsequently choose to undergo surgery may enroll in the surgical cohort of GOG 0199).

Women with psychiatric, psychological or other conditions which prevent fully informed
consent.

Women with current untreated malignancy (excluding non-melanoma skin cancer).

Women with adjuvant radiation therapy or chemotherapy within the past 1 month (31 days).
For purposes of this study, any biologic agent administered with an anti-cancer
therapeutic intent (e.g., Herceptin) will also not be permitted.

Women who have been treated for prior metastatic malignant disease within the past 5
years.

Women who have undergone intraperitoneal surgery within the prior 3 months (includes
laparoscopy).

Women who have had both ovaries removed prior to study entry.

Women with a history of any medical condition which places the subject at risk related to
the need for donating blood for research purposes, e.g., chronic infectious diseases,
severe anemia, hemophilia.

Note: Enrollment of women in whom there is a significant pre-operative clinical suspicion
that there might exist ovarian or fallopian tube caner should be avoided. The intent of
the study is to ascertain subjects who are contemplating a risk-reducing, rather than a
therapeutic, procedure. Women with findings of uncertain significant on baseline TVUS
remain eligible.