Use of CA125 and Complementary Biomarkers for the Early Detection of Ovarian Cancer in Low Risk Women

Prior treatment

• Prior removal of both ovaries.
• Women who have a history of non-ovarian malignancy will be eligible if they have no persistent or recurrent disease and have not received treatment for \>12 months. If they are on SERMS (i.e. tamoxifen or aromatase inhibitors) they will not be excluded. Women maybe undergoing or have had treatment \<12 months prior to study entry for basal cell carcinoma only.

Other illness

• Psychiatric or psychological or other conditions which prevent a fully informed consent.
• Active non-ovarian malignancy.
• Hereditary Nonpolyposis Colorectal Cancer (HNPCC)/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam criteria.

Age

• Female: Less than 50 years old or older than 75 years at the time of enrollment.
• High risk for ovarian cancer due to familial predisposition as defined by the following: a. Known mutation in BRCA1 of BRCA2. b. Two 1st or 2nd degree relatives of same lineage who have: two ovarian cancers; one ovarian cancer \& one pre-menopausal breast cancer; two pre-menopausal breast cancers; one pre-menopausal \& one post-menopausal breast cancer. (These conditions can also be met using the patient and one 1st or 2nd degree female relative.) c. Ashkenazi Jewish descent with one 1st degree or two 2nd degree relatives with pre-menopausal breast or ovarian cancer or participant has had pre-menopausal breast cancer. d. 1st or 2nd degree male relative with breast cancer diagnosed at any age. (First degree relative defined as children, siblings and parents. Second degree relative defined as half-siblings, aunts, uncles, nieces, nephews, grandparents, and grandchildren.)

• Female, \>/= 50 years old or less than 75 years old.
• Postmenopausal (\>/= 12 months amenorrhea).
• Have at least one ovary.
• Cancer-free and have not received any chemotherapy or radiation therapy for \>/=12 months prior to enrolling on this study.
• Willingness to return for CA 125 blood tests annually or earlier if indicated.
• Willingness to return to undergo transvaginal ultrasound if indicated.
• Women need to provide the name of a gynecologist or qualified healthcare professional willing to provide appropriate follow-up care if indicated