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

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。目前尚不清楚什么样的筛查/预防过程是最有效的和最有害的妇女与已知的遗传风险因素的发展卵巢癌，乳腺癌和弥漫性腹膜癌。在许多地方，BRCA 1/2阳性或有卵巢癌家族史的妇女接受RRSO，而许多其他妇女更愿意接受定期筛查测试（经阴道超声）。目前还没有充分的证据表明哪一种方法上级。因此，研究人员设计了一项大型多中心前瞻性观察性RRSO试验，定期随访和每季度检测CA-125和ROCA（CA-125的风险调整随访）与每季度超声和CA-125/ROCA。此外，研究中的所有女性将接受每年两次的社会心理问卷调查，以确定手术的影响，对发展癌症的可能性的不安全感等。研究者计划在RRSO组中招募约1000例受试者，在筛选组中招募2400例患者。所有患者在入院时都将接受BRCA 1/2检测，研究人员预计每组将包含至少400名突变携带者。其他辅助研究包括对手术标本进行更彻底的癌灶检查，并收集一些样本进行进一步的培养研究。试验的终点包括恶性肿瘤的发展。这项大型多中心研究是最近开始的，

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