NCT02595281已完成不适用
Determination of the Interest of HE4 as a Relapse Biomarker in Ovarian Cancers Stages IIIb, IIIc and IV After Neo-adjuvant Chemotherapy and Surgery.
Institut de Cancérologie de Lorraine14 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 14
- 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 more sensitive marker than CA-125 in patients with ovarian cancers. The interest of serum HE4 before surgery has been demonstrated to predict overall survival and its interest has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk patients. To date, no study shows clearly the predictive potential of serum HE4 as an early relapse biomarker in ovarian cancers.
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
- •Ovarian adenocarcinoma stage IIIa, IIIb or IV pleural, cytologically or histologically proven
- •Patient scheduled to undergo neoadjuvant chemotherapy based on platinum followed by surgery and adjuvant chemotherapy
- •Age ≥ 18 years .
- •Performance status ECOG > or = 2
- •Adequate haemoglobin rate ≥ 10 g/dL
- •Ability to provide written informed consent
- •Patient's legal capacity to consent to study participation
排除标准
- •Any previous treatment with platinum for ovarian carcinoma
- •Patient with visceral metastases
- •Contraindication for blood test
- •Contraindication for surgery
- •Contraindication for bevacizumab treatment
结局指标
主要结局
To evaluate the predictive and prognostic value of HE4 marker
时间窗: 24 months
Serum concentration of HE4 (pMol) will be analysed at each visit
次要结局
- Evaluate the quality of surgery(24 months)
- Compare the evolution of HE4 and CA-125 serum concentration(24 months)
- Evaluate the progression-free survival at 18 months(24 months)
研究者
研究点 (14)
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