This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. CA125 is a biomarker for the presence of ovarian cancer that may identify many ovarian cancers before clinical symptoms develop. We hypothesize that for women with a high risk of developing ovarian cancer, screening for ovarian cancer or peritoneal carcinomatosis with frequent CA125 measurements and ultrasound may permit earlier detection than current practice. Such a trial would also permit initial estimation of the incidence of ovarian cancer by age and menopausal status. While not the endpoint of this pilot study, earlier detection may lead to an increased survival. A retrospective analysis of data from a randomized pilot trial of screening with CA 125 in post-menopausal women at normal risk for breast cancer indicated that using the computed mechanism: the Risk of Ovarian Cancer Algorithm (ROCA), substantially improved sensitivity and positive predictive value of using CA125 measurements to predict ovarian cancer. ROCA calculates the risk of having ovarian cancer based on the age, family history and longitudinal CA125 values. Women with a BRCA1 or BRCA2 mutation have an increased lifetime risk for ovarian cancer that is 10-20 fold higher than that of women without such mutations. As well, women with a strong family history of breast and/or ovarian cancer may also be at higher risk. These women, at an increased risk either because of a known inherited predisposition to ovarian cancer or a strong family history, are routinely screened with CA125 blood tests and/or transvaginal ultrasounds. These screening tests are used individually or in combination. This study is designed to determine the sensitivity and specificity of the effectiveness of regular surveillance using longitudinal CA125 tests in combination with transvaginal ultrasounds in detecting ovarian cancer at early stages in woman at high risk for ovarian cancer. Currently approximately 50% of women with BRCA 1 and BRCA 2 mutations undergo prophylactic oophorectomy, usually prior to natural menopause. Premature menopause increases the risk of atherosclerosis and osteoporosis. Yet, prophylactic oophorectomy is done in the absence of knowing the incidence of ovarian cancer in high risk, premenopausal women. This trial permits an initial estimation of the incidence of ovarian cancer by age and menopausal status.
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