Development of an Assay for the Early Detection of Ovarian Cancer.

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Meets 1 of the following criteria:

- Presenting to a gynecological oncologist with a unilateral or bilateral pelvic
mass (defined as a simple, complex, or a solid ovarian/pelvic mass) and
scheduled to undergo surgery

- Newly diagnosed epithelial ovarian cancer and undergoing first-line chemotherapy

- History of epithelial ovarian carcinoma status post-primary chemotherapy
treatment, currently in clinical remission according to the following criteria:

- Absence of symptoms that may be related to disease

- Imaging without abnormalities ≥ 1 cm suspicious for disease (no ascites)

- CA125 obtained twice at least 3 weeks apart and not increasing by 50% and <
40 units/mL

- Known BRCA mutations and intact ovaries (no prior bilateral
salpingo-oophorectomy)

- No synchronous primary endometrial cancer or a past history of primary endometrial
cancer, unless all of the following conditions are met:

- Stage not greater than IB

- No more than superficial myometrial invasion, without vascular or lymphatic
invasion

- No poorly differentiated subtypes, including papillary serous, clear cell, or
other FIGO grade 3 lesions

- No epithelial ovarian carcinoma of low malignant potential (borderline carcinomas)

- Patients of any stage who have recurred and are in second chemotherapy induced
remission are not eligible

PATIENT CHARACTERISTICS:

- Pre- or post-menopausal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other invasive malignancies within the past 5 years, with the exception of
nonmelanoma skin cancer

- No septicemia, severe infection, or acute hepatitis

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior radiotherapy to any portion of the abdominal cavity or pelvis

- No prior chemotherapy for another malignancy