Use of CA125 and Complementary Biomarkers for the Early Detection of Ovarian Cancer in Low Risk Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,000
- 试验地点
- 19
- 主要终点
- Rate of increase in CA 125 levels and other tumor markers over time
研究概览
简要总结
The goal of this clinical research study is to find out if combining a standard blood test (CA-125) that checks for ovarian cancer with other blood tests that check for related tumor markers may be helpful in the early detection of ovarian cancer in women who are at low risk. Tumor markers are substances in the blood that may be related to ovarian cancer.
详细描述
Up to 8,000 women will take part in this multicenter study.
Currently, there is no effective screening to detect ovarian cancer at its earliest stage in low risk women. CA-125 is an FDA approved blood test that may show the presence of ovarian cancer. Researchers have found other blood tests that detect ovarian cancers that may be missed by CA125 testing. Results of blood tests are combined into a Risk of Ovarian Cancer-2 (ROCA2) score to decide whether you need to return for additional bloodwork and/or an ultrasound.
If you are eligible to take part in this research study:
You will have blood (about 3-4 tablespoons) drawn for testing of tumor markers that can detect ovarian cancer.
You will be asked to complete a questionnaire about your medical and family history. It should take about 20-30 minutes to complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, >/= 50 years old or less than 75 years old.
- •Postmenopausal (>/= 12 months amenorrhea).
- •Have at least one ovary.
- •Cancer-free and have not received any chemotherapy or radiation therapy for >/=12 months prior to enrolling on this study.
- •Willingness to return for CA 125 blood tests annually or earlier if indicated.
- •Willingness to return to undergo transvaginal ultrasound if indicated.
- •Women need to provide the name of a gynecologist or qualified healthcare professional willing to provide appropriate follow-up care if indicated
排除标准
- •Female: Less than 50 years old or older than 75 years at the time of enrollment.
- •Psychiatric or psychological or other conditions which prevent a fully informed consent.
- •Prior removal of both ovaries.
- •Active non-ovarian malignancy.
- •Women who have a history of non-ovarian malignancy will be eligible if they have no persistent or recurrent disease and have not received treatment for >12 months. If they are on SERMS (i.e. tamoxifen or aromatase inhibitors) they will not be excluded. Women maybe undergoing or have had treatment <12 months prior to study entry for basal cell carcinoma only.
- •High risk for ovarian cancer due to familial predisposition as defined by the following: a. Known mutation in BRCA1 of BRCA
- •b. Two 1st or 2nd degree relatives of same lineage who have: two ovarian cancers; one ovarian cancer & one pre-menopausal breast cancer; two pre-menopausal breast cancers; one pre-menopausal & one post-menopausal breast cancer. (These conditions can also be met using the patient and one 1st or 2nd degree female relative.) c. Ashkenazi Jewish descent with one 1st degree or two 2nd degree relatives with pre-menopausal breast or ovarian cancer or participant has had pre-menopausal breast cancer. d. 1st or 2nd degree male relative with breast cancer diagnosed at any age. (First degree relative defined as children, siblings and parents. Second degree relative defined as half-siblings, aunts, uncles, nieces, nephews, grandparents, and grandchildren.)
- •Hereditary Nonpolyposis Colorectal Cancer (HNPCC)/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam criteria.
研究组 & 干预措施
CA 125 Analysis
Experimental: CA-125 Analysis
Experimental: CA-125, HE4, and Osteopontin bio-marker analysis. Participants will have blood (3-4 tablespoons) drawn for CA-125 and other tumor markers.
Depending on CA-125 level and other tumor markers:
Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers in 1 year.
Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers in 3 months, OR
Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers, and a transvaginal ultrasound in 6 weeks +/- 2 weeks.
干预措施: Questionnaire (Behavioral)
结局指标
主要结局
Rate of increase in CA 125 levels and other tumor markers over time
时间窗: Based on CA-125 level, 3 options will result: 1) re-draw blood (CA-125) in 1 year, 2) re-draw blood (CA-125) in 3 months), or 3) re-draw blood (CA-125) AND TVUS in 6 weeks +/- 2 weeks.
\[Time Frame: Based on CA-125 level and other tumor markers, 3 options will result: 1) re-draw blood (CA-125 and other tumor markers) in 1 year, 2) re-draw blood (CA-125 and other tumor markers) in 3 months, or 3) re-draw blood (CA-125 and other tumor markers) and TVUS in 6 weeks +/- 2 weeks.\]
次要结局
未报告次要终点