Prospective Validation of the Association Between Circulating Tumor DNA Detection and Risk of Metastatic Relapse in Patients With Localized Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Recurrence-free survival
研究概览
简要总结
The objective of this study is to identify a population at risk of early recurrence after oncologic resection surgery of a primary uterine tumor based on the detection of ctDNA
详细描述
Despite early management, the risk of recurrence in non-metastatic endometrial cancer (FIGO I-III) is approximately 10-20%. The challenge is to identify the most high-risk cases for relapse in order to adapt surgical and medical management.
The development of digital PCR methods in nano-droplets, detecting circulating tumor DNA (ctDNA) with high sensitivity, could help to better specify the prognosis of patients with localized endometrial cancer and to identify a population with residual disease, the source of this ctDNA.
The investigators established a universal methylation signature in the laboratory based on analysis of endometrial cancer-specific DNA methylation using in silico analysis of public data from the Cancer Genome Atlas, validated in an independent cohort, with 99% sensitivity and 98% specificity.
A prospective biological cohort was established between the gynecology and medical oncology departments and the Cochin Hospital biological resources center (CARPEM-OncoCentre collection).
This is a prospective monocentric biological collection study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 patients over 18 years of age who are potentially eligible for inclusion in the OncoCentre collection (registered as a patient at APHP, without legal protection measures, affiliated with a social security system)
- •Patients diagnosed with histologically documented endometrial cancer on an endometrial biopsy
- •Surgical intervention performed at Hopital Cochin
排除标准
- •Failure to sign the OncoCentre consent form
- •Refusal of OncoCentre consent
- •Patient not eligible for upfront curative surgical treatment
结局指标
主要结局
Recurrence-free survival
时间窗: 1 year
次要结局
- Recurrence-free survival(3 years)
- Frequency of ctDNA detection in other prognostic groups(3 years)
- Frequency of ctDNA detection based on established prognostic parameters(3 years)
- Frequency of ctDNA detection based on the recurrence profile(3 years)