Determination of the Prognostic and Predictive Value of the New Marker HE4 in Metastatic Ovarian Cancer Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 4
- 主要终点
- To evaluate the predictive and prognostic value of HE4 marker
研究概览
简要总结
HE4 is a new marker that could improve the detection of ovarian cancer. The HE4 assay may have an advantage over the CA-125 assay in that it is less frequently positive in patients with non malignant disease. Since the evaluation of HE4 for detection and diagnosis of ovarian cancer is well known, the behaviour of the marker during chemotherapy and follow-up period after treatment in metastatic ovarian cancer should be studied. It could be used in patient with non CA-125 secretary tumors. Prognosis and predictive value of HE4 should be compared with information provided by CA-125. The kinetics of HE4 values after treatment should be also analysed to determine the role that HE4 could play in the detection of recurrences during the follow-up of metastatic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Histologically proved epithelial ovarian cancer (serous, mucinous, clear cell, endometrioid, undifferentiated type)
- •Recurrence of anytime necessitating a new line of chemotherapy
- •Patient having received adjuvant chemotherapy
- •Informed consent signed prior any study specific procedures
排除标准
- •More than 3 lines of chemotherapy
- •Pregnancy or breastfeeding
- •History of other cancers within the past 5 years (except curatively treated non-melanoma skin cancer and in situ cervical cancer)
- •Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment modalities and study follow-up).
结局指标
主要结局
To evaluate the predictive and prognostic value of HE4 marker
时间窗: 18 months
次要结局
- Determine the rate of patients without elevation of CA-125 presenting an elevation of HE4 that could be used for monitoring the disease.(18 months)