Clinical Protocol to Evaluate Glycans Analysis As a Diagnostic Test for Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 581
- 试验地点
- 1
- 主要终点
- Accuracy of glycan analysis
研究概览
简要总结
RATIONALE: New diagnostic procedures, such as glycan analysis, may be effective in finding ovarian epithelial cancer.
PURPOSE: This clinical trial is studying how well glycan analysis works in diagnosing cancer in women with ovarian epithelial cancer and in healthy female participants.
详细描述
OBJECTIVES:
Primary
- Evaluate the accuracy of glycan analysis to distinguish between normal healthy control female subjects and those with ovarian epithelial cancer.
Secondary
- Compare the new assay to the standard CA 125 for diagnostic accuracy.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able to understand consent document for participation in the study
- •Not pregnant
- •Negative pregnancy test
- •Participants must meet 1 of the following criteria:
- •Patients scheduled for ovarian surgery for an ovarian mass
- •Healthy female volunteers with no active cancer or history of cancer
排除标准
- 未提供
结局指标
主要结局
Accuracy of glycan analysis
时间窗: one time for healthy volunteers; up to 2 years for patients with cancer
For healthy controls, a single sample will be obtained. For patients scheduled for surgery, two samples will be obtained: one preoperatively and one postoperatively. Ovarian cancer patients who agree to participate in the longitudinal study will have follow-up serum samples drawn periodically during chemotherapy treatments and then during surveillance visits, to correspond with routine blood testing for CA 125. They will be asked to participate for 2 years, with a maximum of 8 blood draws per year (to be coordinated with other venipunctures, if possible).
次要结局
- Comparison of the new assay to the standard CA 125 assay(one time for healthy volunteers; up to 2 years for patients with cancer)