Evaluation of CA125 and HE4 Assays to Estimate the Risk of Ovarian Cancer in Patients Presenting to a General Surgeon or Obstetrician/Gynecologist With an Adnexal Mass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 512
- 试验地点
- 13
- 主要终点
- 1. A statistically higher number of cancer patients are correctly assigned by the combination of Initial Cancer Risk assessment and positive ROMA test result than by Initial Cancer Risk assessment alone
研究概览
简要总结
The purpose of this study is to determine whether the Risk of Ovarian Cancer Algorithm (ROMA) is effective in the determination of a woman's risk of cancer when she is scheduled to have surgery to remove a pelvic mass.
After Informed Consent is obtained, an Initial Cancer Risk Assessment will be made. A blood sample will be collected within 30 days of the surgical procedure. Results of the surgical procedure will be collected and analyzed against the CA125 and HE4 results used in the calculation of the ROMA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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, age ≥ 18 years
- •Adnexal mass present documented by imaging
- •Scheduled to undergo surgery based on a finding of adnexal mass (defined as a simple, complex or a solid ovarian cyst/or any mass in pelvis)
- •Able to understand and willing to provide Informed Consent
排除标准
- •Previous history of ovarian cancer
- •Previous history of bilateral oophorectomy
- •Currently known to be pregnant
- •Unable to provide informed consent
结局指标
主要结局
1. A statistically higher number of cancer patients are correctly assigned by the combination of Initial Cancer Risk assessment and positive ROMA test result than by Initial Cancer Risk assessment alone
时间窗: Blood draw within 30 days of surgery
次要结局
未报告次要终点