CANCER GENETICS NETWORK (CGN) OVARIAN SCREENING PILOT TRIAL IN HIGH RIS WOMEN

癌症遗传学网络 (CGN) 在高危女性中进行卵巢筛查试点试验

• 批准号: 7608283
• 负责人: Claudine Isaacs
• 金额: $ 12.78万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 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 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608283
• 关键词: Age; Algorithms; BRCA1 gene; BRCA2 Mutation; BRCA2 gene; Bilateral oophorectomy; Biological Markers; Blood; Breast; CA-125 Antigen; Cancer Genetics Network; Carcinomatosis; Categories; Classification; Clinical; Computer Retrieval of Information on Scientific Projects Database; Databases; Decision Making; Disease; Early Diagnosis; Effectiveness; Eligibility Determination; Environmental Exposure; Evaluation; Family; Family history of; Funding; Genes; Goals; Grant; Health; High Risk Woman; Histologic; Hour; Incidence; Inherited; Institution; Laboratories; Malignant neoplasm of ovary; Measurement; Measures; Menopausal Status; Moths; Mutation; National Cancer Institute; Normal Range; Operative Surgical Procedures; Ovarian; Ovariectomy; Participant; Patients; Peritoneal; Physicians; Plasma; Postmenopause; Predictive Value; Quality of life; Questionnaires; Recording of previous events; Recruitment Activity; Recurrence; Research; Research Personnel; Resources; Risk; Sampling; Screening for Ovarian Cancer; Screening procedure; Shipping; Ships; Site; Solutions; Source; Specificity; Staging; Survival Rate; Test Result; Testing; Time; Triage; Tumor Markers; Ultrasonography; United States Food and Drug Administration; United States National Institutes of Health; Upper arm; Week; Woman; abstracting; base; cancer diagnosis; cancer risk; clinical Diagnosis; design; lifetime risk; malignant breast neoplasm; pilot trial; programs; prophylactic; prospective; repository; research study

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. As of 2/07/06: Despite new therapies, the five-year survival rate for patients with ovarian cancer has not changed significantly over the past thirty years. When detected in early stages, however, survival from ovarian cancer is usually better than when it is detected at later stages. This study is an ovarian cancer screening protocol, using a test called CA125. CA125 is an FDA approved marker for detecting recurrence of disease in women who have already had ovarian cancer. This research study aims to determine if CA125 is helpful in the early detection of ovarian cancer among women at high-risk for ovarian cancer due to a family history of breast or ovarian cancer, or an inherited alteration in genes called BRCA1 and BRCA2. A secondary goal of this study is to assess the impact of ovarian cancer screening on women's quality of life. This study is part of the Cancer Genetics Network (CGN) sponsored by the National Cancer Institute (NCI) and will evaluate study participants over a two to three-year period testing the effectiveness of CA125. Participation in this project will also help identify women in a high-risk category with the hope of detecting ovarian cancer early. Patients in this risk group will be referred by their physicians for ultrasound, laparascopy and/or surgery if it is indicated by the results of these tests. Initial Abstract: Women with a BRCA1 and BRCA2 mutation have an increased lifetime risk for ovarian cancer of 10-20 fold higher than women without such mutations. Even after prophylactic surgery women may develop peritoneal carcinomatosis, a disease clinically and histologically identical to late stage ovarian cancer. We hypothesize that for women with a high risk of developing ovarian cancer, screening for ovarian cancer or peritoneal carcinomatosis with longitudinal CA125 measurements and ultrasound may permit earlier detection than current practice. Such a screening trial would also permit initial estimation of the incidence of ovarian cancer by age and menopausal status. There are four specific aims of this trial: 1) determine the feasibility of prospective programs, and identify the logistical issues of screening and their solutions within this framework; 2) establish normal ranges and distribution within and between high risk women for CA125 values over time, with sub-classification by pre/post-menopausal status, ERT usage (yes/no), and prophylactic oophorectomy (yes/no); 3) obtain estimates of the specificity and positive predictive value of ROCA (risk of ovarian cancer algorithm)suitable for desgning a definitve trial of screening for ovarian cancer in high risk women; 4) establish a longitudinal serum and plasma bio-repository for retrospective evaluation of other promising biomarkers with special relevance to inherited ovarian and breast cancer risk. The CGN ovarian screening trial is a mulit-center trial, recruiting women from families with high risk for ovarian cancer. The design is a prospective one=armed study with decision making based on the tumor marker CA125 levels measured in blood at baseline and every three-moth interval. Subjects will be recruited over a period of twelve moths, screened for at lease one year and for up to two years if recruited at the beginning of the recruitment period, and followed for clinical diagnosis of cancer for an additional year. For each new CA125 measurement, the ROCA will be calculated and stored in the CGN clinical database. ROCA calculates the risk of having ovarian cancer based on age, family history, and longitudinal CA125 values and then triages the subject according to the level of risk. The CA125 value and the action to be taken will be emailed to the site project manager immediately upon availability of the risk of having ovarian cancer. The choice of action will depend on the level of risk, and the site will be responsible for contacting the patient. Subjects will also be asked to complete a baseline questionnaire asking about health history, environmental exposures, and family history, as well as brief questionnaires at each blood draw regarding any changes in the subject's health since the last CA125 test. The GCRC will perform blood draws on study participants, and will spin samples within 24 hours of each draw. The GCRC will also store samples at -70o C until shipping to the central laboratory every week.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 截至2/07/06： 尽管有新的疗法，但在过去的三十年中，卵巢癌患者的五年生存率并未发生显着变化。 但是，在早期发现时，卵巢癌的生存通常比在后期发现的卵巢癌生存更好。 这项研究是一种使用称为CA125的测试，是一种卵巢癌筛查方案。 CA125是FDA批准的标记，用于检测已经患有卵巢癌的女性疾病复发。 这项研究旨在确定CA125是否有助于由于乳腺癌或卵巢癌的家族史，还是在高风险的卵巢癌中对卵巢癌的早期发现，或称为BRCA1和BRCA2的遗传改变。 这项研究的次要目标是评估卵巢癌筛查对女性生活质量的影响。 这项研究是国家癌症研究所（NCI）赞助的癌症遗传网络（CGN）的一部分，并将在两到三年的时间内评估研究参与者，以测试CA125的有效性。 参与该项目还将有助于确定高风险类别的女性，希望尽早发现卵巢癌。 如果这些测试的结果表明，则该风险组中的患者将由其医生进行超声检查，腹腔内和/或手术转诊。 初始摘要： 患有BRCA1和BRCA2突变的女性患卵巢癌的寿命风险增加了10-20倍的倍数，而没有这种突变的女性。即使在预防手术后，妇女也可能患上腹膜癌，这是一种疾病，在临床和组织学上与晚期卵巢癌相同。我们假设对于患有卵巢癌的高风险，筛查卵巢癌或腹膜癌和纵向CA125测量和超声检查的女性可能允许比目前的实践更早地进行检测。这样的筛查试验还将允许对年龄和绝经状态的卵巢癌发病率进行初步估计。该试验有四个具体的目的：1）确定潜在计划的可行性，并在本框架内确定筛查及其解决方案的后勤问题； 2）在CA125值的高风险女性内和在高风险妇女之间建立正常范围和分布，随着时间的推移/绝经后状态，ERT使用情况（是/否）和预防性的卵形切除术（是/否），并进行了亚分类； 3）获得适合于高风险女性卵巢癌筛查的确定试验的ROCA（卵巢癌算法的风险）的特异性和积极预测价值的估计； 4）建立纵向血清和等离子体生物叛逆者，以回顾性评估其他有前途的生物标志物，与遗传的卵巢癌和乳腺癌风险特别相关。 CGN卵巢筛查试验是一项Mulit-Center试验，招募了来自患有卵巢癌风险的家庭的妇女。该设计是一项前瞻性的一项=武装研究，其决策基于肿瘤标记物CA125水平在基线和每三个摩托车间隔时测得的。受试者将在十二个飞蛾中招募，如果在招募期开始时招募了一年的租赁，最多可招募两年，则随后进行癌症的临床诊断一年。对于每个新的CA125测量，将计算ROCA并存储在CGN临床数据库中。 ROCA根据年龄，家族史和纵向CA125值来计算患卵巢癌的风险，然后根据风险水平将受试者分类。 CA125的价值和要采取的行动将在患有卵巢癌的风险下立即通过电子邮件发送给现场项目经理。行动的选择将取决于风险水平，该站点将负责与患者联系。还将要求受试者填写一份基线问卷，询问有关健康历史，环境暴露和家族史的询问，以及自上次CA125测试以来受试者健康的任何变化的每次血液中的简短问卷。 GCRC将对研究参与者进行抽血，并在每次抽奖后的24小时内旋转样品。 GCRC还将在-70o C中存储样品，直到每周运送到中央实验室。