GOG-0199: USING SALPINGO-OOPHORECTOMY AND CA-125 TO SCREEN FOR OVARIAN CANCER

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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. It is not clear what course of screening/prevention is most efficacious and least harmful in women with known genetic risk factors for development of ovarian, breast and diffuse peritoneal carcinoma. In many places women who are BRCA1/2 positive or who have a strong family history of development of ovarian cancer undergo RRSO, whereas many other women prefer to undergo periodic screening tests (trans-vaginal ultrasound). There is no good evidence to suggest that one course or the other is superior at present. Therefore, the investigators have devised a large multicenter prospective observational trial of RRSO with periodic follow-up and quarterly testing for CA-125 and ROCA (risk adjusting follow-up of CA-125) versus quarterly ultrasound and CA-125/ROCA. In addition, all women in the study will undergo twice yearly administration of psychosocial questionnaires to determine the impact of surgery, insecurity about possibility of developing cancer, etc. The investigators intend to enroll approximately 1000 subjects in the RRSO group and 2400 patients in the screening group. All patients will be tested for BRCA1/2 at admission, and the investigators expect that each group will contain at least 400 mutation carriers. Other side studies include more thorough examination of surgical specimens for foci of carcinomatosis and collection of some samples for further study by culture. The endpoints for the trial include development of malignancy. This large multicenter study was recently initiated on t