NCT04487405终止不适用
A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 721
- 试验地点
- 9
- 主要终点
- OVAnex
研究概览
简要总结
The objective of this project is to validate the sensitivity, specificity, positive predictive value and negative predictive values of the AMRA blood test for assessing risk of cancer in women at high risk for ovarian cancer, due to the presence of a symptomatic adnexal mass.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient, 18 years of age or older diagnosed with an ovarian adnexal mass, or in follow-up due to the presence of BRCA1/2 and other germline DNA variants.
- •Patient reviewed, understood, and provided the PI with written informed consent to allow blood specimen to be used for research and release of medical information.
排除标准
- •Patient is less than 18 years of age
- •Patient is not being treated in the U.S.
结局指标
主要结局
OVAnex
时间窗: 12 months
OVAnex is a multivariate index assay assessing ovarian cancer risk. The Ovanex MIA uses seven biomarkers with a stepwise algorithm to generate a risk score which ranges from 0 to 20.
次要结局
未报告次要终点
研究者
研究点 (9)
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