Non-Invasive Diagnosis of Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Activating variants and MSI via cytology
研究概览
简要总结
The study aims to determine whether next generation sequencing and microsatellite analysis of cervical cytology is sensitive for the detection of endometrial carcinoma.
详细描述
Definitive diagnosis of endometrial cancer relies on endometrial biopsy, in addition to imaging. Biopsy is however invasive and often painful, and its sensitivity in only moderate. Cervical cytology could be an alternative. This is a proof-of-concept study. The investigators will carry out next generation sequencing of cervical cytology in patients with confirmed endometrial carcinoma, in order to determine whether activating variants are identified. About 15% of endometrial carcinomas are microsatellite instable (MSI). The investigators will therefore also carry out MSI analysis using MSICare in the subset of cases with MMR-deficient cancer.
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
- •Endometrial cancer requiring hysterectomy
- •Patient covered by French social Security
- •Patient capable of giving written informed consent
排除标准
- •Chemotherapy
研究组 & 干预措施
Endometrial cancer patients
Endometrial cancer patients Cervical cytology during surgical intervention.
干预措施: cervical cytology during surgery. (Procedure)
结局指标
主要结局
Activating variants and MSI via cytology
时间窗: 16 months
proportion of cases in whom genetic activating variants and microsatellite instability are detected by cytology
次要结局
- Comparison with the proportion of variants seen on the pathological(16 months)
- Frequency of variants(16 months)
- Number of variants(16 months)
- Comparison with the proportion of microsatellite instability detected on the pathological specimen.(16 months)
- Type of variants(16 months)