MACGN

麦肯锡

• 批准号: 7604556
• 负责人: DEBORAH K ARMSTRONG
• 金额: $ 0.04万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604556
• 关键词: Age; Algorithms; Atherosclerosis; BRCA1 gene; BRCA2 Mutation; Bilateral oophorectomy; Biological Markers; Blood Tests; Breast; CA-125 Antigen; Carcinomatosis; Clinical; Computer Retrieval of Information on Scientific Projects Database; Data Analyses; Early Diagnosis; Effectiveness; End Point; Family history of; Funding; Genetic Predisposition to Disease; Grant; High Risk Woman; Incidence; Institution; Lead; Malignant neoplasm of ovary; Measurement; Medical Surveillance; Menopausal Status; Menopause; Mutation; Osteoporosis; Ovariectomy; Peritoneal; Pilot Projects; Postmenopause; Predictive Value; Premature Menopause; Premenopause; Randomized; Research; Research Personnel; Resources; Risk; Screening for Ovarian Cancer; Screening procedure; Sensitivity and Specificity; Source; Staging; Symptoms; Testing; Transvaginal Ultrasound; Ultrasonography; United States National Institutes of Health; Woman; base; design; improved; lifetime risk; malignant breast neoplasm; pilot trial; prophylactic

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 CA 125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许多卵巢癌。 我们假设，对于卵巢癌高危女性，通过频繁的CA 125测量和超声筛查卵巢癌或腹膜癌转移可能比目前的做法更早发现。这样的试验也可以通过年龄和绝经状态初步估计卵巢癌的发病率。 虽然不是这项初步研究的终点，但早期检测可能会增加生存率。一项回顾性分析的数据，从一个随机试点试验的筛选与CA 125在绝经后妇女在正常风险的乳腺癌表明，使用计算的机制：卵巢癌的风险算法（ROCA），大大提高了敏感性和阳性预测值使用CA 125测量预测卵巢癌。 ROCA根据年龄、家族史和纵向CA 125值计算患卵巢癌的风险。 BRCA 1或BRCA 2突变的女性患卵巢癌的终生风险比没有这种突变的女性高10-20倍。 同样，有乳腺癌和/或卵巢癌家族史的女性也可能处于更高的风险中。 这些妇女，由于已知的遗传性卵巢癌易感性或强烈的家族史，风险增加，常规筛查CA 125血液测试和/或经阴道超声。 这些筛选测试可单独使用或组合使用。 本研究的目的是确定定期监测的有效性的敏感性和特异性，使用纵向CA 125测试结合经阴道超声检测卵巢癌在早期阶段的妇女在卵巢癌的高风险。 目前，大约50%的BRCA 1和BRCA 2突变的妇女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。 该试验允许通过年龄和绝经状态初步估计卵巢癌的发病率。