Ovarian Cancer Early Detection Screening Program
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 534
- 试验地点
- 2
- 主要终点
- Measuring for elevated levels of tumor marker CA-125 in the blood over time.
研究概览
简要总结
The main purpose of this program is to see whether periodically measuring CA-125 (tumor marker) levels in the blood and undergoing transvaginal ultrasounds over time will be effective in the early detection of ovarian cancer.
详细描述
The program will offer twice yearly CA-125 blood tests and annual transvaginal ultrasounds to monitor women at high risk for ovarian cancer. In addition to the main purpose of providing ovarian cancer screening, the researchers would also like to build a repository of blood specimens for use in ovarian and breast cancer research and to offer genetics counseling sessions to help educate women about risk-reducing options.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must meet one of the following:
- •The family contains at least two ovarian or breast cancers in the subject or first or second degree relatives of the subject.
- •The subject is of Ashkenazi Jewish ethnicity with one first degree or two second-degree relatives with breast or ovarian cancer, or subject is of Ashkenazi ancestry and has had breast cancer.
- •The subject has a male relative with breast cancer diagnosed at any age.
- •Probability of carrying a BRCA1/2 mutation given family pedigree of breast and ovarian cancers exceeds 20% (as determined by BRCAPRO 95% posterior probability interval).
排除标准
- •Prior ovarian cancer or peritoneal carcinomatosis
- •A first or second degree relative with a BRCA1/2 mutation and has tested negative for exactly the same mutation.
- •The subject has no ovaries.
- •Less than 30 years of age, unless 25-30 with BRCA I or II mutation confirmed
- •Currently pregnant
- •Currently receiving adjuvant chemotherapy or radiation therapy for cancer (excluding tamoxifen). Patients who are being treated for local disease may enroll 3 months after completion of last treatment (excluding tamoxifen).
- •Treatment (excluding tamoxifen) for prior metastatic malignancy within the past five years.
- •Intraperitoneal surgery within the last 3 months.
结局指标
主要结局
Measuring for elevated levels of tumor marker CA-125 in the blood over time.
时间窗: Average expected time of 1 year
次要结局
- Performing transvaginal ultrasounds to look for any abnormalities over time.(Average expected time of 1 year)
- Performing health status questionnaires over time(Average expected time of 1 year)