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.

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