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

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。目前尚不清楚哪种筛查/预防方案对患有卵巢癌、乳腺癌和弥漫性腹膜癌的已知遗传风险因素的妇女最有效、危害最小。在许多地方，BRCA1/2阳性或有卵巢癌家族史的妇女接受RRSO，而许多其他妇女更喜欢接受定期筛查检查(经阴道超声)。目前，没有充分的证据表明这两门课程中的一门更好。因此，研究人员设计了一项大型多中心RRSO前瞻性观察试验，定期随访并每季度检测CA-125和ROCA(调整CA-125的随访风险)与季度超声和CA-125/ROCA。此外，研究中的所有女性都将每年接受两次心理社会问卷调查，以确定手术的影响、对患癌症可能性的不安全感等。调查人员打算将大约1000名受试者纳入RRSO组，2400名患者加入筛查组。所有患者入院时都将接受BRCA1/2检测，调查人员预计每组患者至少有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症病灶检查，以及收集一些样本以供进一步培养研究。试验的终点包括恶性肿瘤的发展。这项大型多中心研究最近在t

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