MACGN

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。CA125是卵巢癌存在的生物标志物，可以在临床症状出现之前识别出许多卵巢癌。我们假设，对于患卵巢癌的高风险妇女，通过频繁的CA125测量和超声筛查卵巢癌或腹膜癌可能比目前的做法更早发现。这样的试验还可以根据年龄和更年期状况初步估计卵巢癌的发病率。虽然不是这项初步研究的终点，但早期发现可能会增加生存率。一项对正常乳腺癌风险的绝经后妇女CA125筛查的随机试验数据的回顾性分析表明，使用计算机制：卵巢癌风险算法（ROCA），大大提高了使用CA125测量预测卵巢癌的敏感性和阳性预测值。ROCA根据年龄、家族史和纵向CA125值计算患卵巢癌的风险。携带BRCA1或BRCA2突变的女性一生患卵巢癌的风险比没有这种突变的女性高10-20倍。同样，有强烈的乳腺癌和/或卵巢癌家族史的女性也可能有更高的风险。由于已知的遗传性卵巢癌易感性或强烈的家族史，这些妇女患卵巢癌的风险增加，应常规进行CA125血液检查和/或经阴道超声检查。这些筛选测试可单独使用或组合使用。本研究旨在确定纵向CA125检测联合经阴道超声定期监测在卵巢癌高危妇女早期检测卵巢癌有效性的敏感性和特异性。目前，大约50%的brca1和brca2突变女性接受预防性卵巢切除术，通常在自然绝经之前。过早绝经会增加动脉粥样硬化和骨质疏松症的风险。然而，预防性卵巢切除术是在不了解高危绝经前妇女卵巢癌发病率的情况下进行的。该试验允许按年龄和绝经状态对卵巢癌发病率进行初步估计。

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.