CANCER GENETICS NETWORK (CGN) OVARIAN SCREENING PILOT TRIAL IN HIGH RISK 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: 7608495
• 负责人: Claudine Isaacs
• 金额: $ 2.63万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608495
• 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.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 截至2006年07月2日： 尽管有新的治疗方法，但卵巢癌患者的五年存活率在过去30年里没有显著变化。然而，在早期被发现时，卵巢癌的存活率通常比在后期被发现时要好。这项研究是一项卵巢癌筛查方案，使用了一种名为CA125的测试。CA125是FDA批准的用于检测已经患有卵巢癌的女性疾病复发的标志物。这项研究旨在确定CA125是否有助于因乳腺癌或卵巢癌家族史或BRCA1和BRCA2基因遗传改变而导致卵巢癌高危女性早期发现卵巢癌。这项研究的第二个目标是评估卵巢癌筛查对女性生活质量的影响。这项研究是由美国国家癌症研究所(NCI)赞助的癌症遗传学网络(CGN)的一部分，将在两到三年的时间内评估研究参与者，测试CA125的有效性。 参与这一项目还将有助于确定高危类别的女性，希望及早发现卵巢癌。如果这些测试的结果表明，这一风险组的患者将被他们的医生转介进行超声波、腹腔镜和/或手术。 初始摘要： 具有BRCA1和BRCA2突变的女性患卵巢癌的终身风险比没有这种突变的女性高10-20倍。即使在预防性手术后，女性也可能患上腹膜癌，这是一种在临床和组织学上与晚期卵巢癌相同的疾病。我们推测，对于卵巢癌高危女性，用纵向CA125测量和超声筛查卵巢癌或腹膜癌可能会比目前的做法更早发现。这样的筛查试验还可以根据年龄和绝经状态初步估计卵巢癌的发病率。这项试验有四个具体目标：1)确定前瞻性计划的可行性，并在此框架内确定筛查的后勤问题及其解决方案；2)建立CA125值的正常范围和在高危妇女之间随时间的分布，并按绝经前/绝经后状态、ERT使用情况(是/否)和预防性卵巢切除术(是/否)进行细分；3)获得适用于设计高危妇女卵巢癌筛查明确试验的ROCA(卵巢癌风险算法)的特异度和阳性预测值的估计；4)建立一个纵向的血清和血浆生物信息库，用于对其他与遗传性卵巢癌和乳腺癌风险特别相关的有希望的生物标志物进行回顾性评估。 CGN卵巢筛查试验是一项多中心试验，招募来自卵巢癌高危家庭的妇女。这项设计是一项前瞻性的武装研究，根据基线和每三个月间隔测量的血液中肿瘤标志物CA125水平进行决策。受试者将在12个月的时间内被招募，筛查至少一年，如果在征募期开始时被招募，则最多两年，并对癌症的临床诊断进行额外一年的跟踪。对于每个新的CA125测量，ROCA将被计算并存储在CGN临床数据库中。ROCA根据年龄、家族史和纵向CA125值计算患卵巢癌的风险，然后根据风险水平对受试者进行分类。CA125值和要采取的行动将在发现卵巢癌风险后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，网站将负责联系患者。受试者还将被要求完成一份基线问卷，询问健康史、环境暴露和家族史，并在每次抽血时填写简短问卷，说明自上次CA125测试以来受试者健康状况的任何变化。 GCRC将对研究参与者进行抽血，并将在每次抽血后24小时内旋转样本。GCRC还将把样本保存在零下70摄氏度，直到每周运往中心实验室。