Pilot Study on the Contribution of Molecular Analysis of Endometrial Cancers: Reliability, and Interest of Circulating Tumor DNA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- The main objective of the study is to determine the concordance rate between molecular analysis of tumor tissue and that of cDNA in patients with endometrial cancer during treatment.
研究概览
简要总结
The recent histo-prognostic molecular discoveries of the TCGA (The Cancer Genome Atlas) have shed new light on the classification of endometrial carcinomas.
After carrying out different types of high-throughput molecular analyzes on 373 endometrial carcinomas of different histological types, 4 major tumor subtypes could be identified, each with a different survival profile (the "ultra-mutated" group with POLE mutations, the "hypermuted" group with microsatellite instability (MSI), the "low number of copies" group, and the "high number of copies" group).
This histomolecular classification is not yet directly transposable to clinical practice and tumor genetic characteristics have not had any direct therapeutic impact to date.
The main objective of the study is to determine the concordance rate between molecular analysis of tumor tissue and that of cDNA in patients with endometrial cancer during treatment.
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 proven endometrial adenocarcinoma type I or type II.
- •With recent abdomino-pelvic imaging, less than 3 months old.
- •Tumor tissue sufficiently exploitable for research (> 20% of tumor cells)
- •Informed consent signed by the patient after clear and fair information about the study.
- •Free patient, without tutorship, curatorship or subordination.
- •Patient benefiting from a Social Security scheme or benefiting from it through a third person.
- •Patient not opposed to participating in the study.
排除标准
- •Histologies other than adenocarcinoma (sarcoma, leiomyosarcoma)
- •Linguistic or mental refusal or incapacity to understand and / or sign the informed consent
- •Patients benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection.
- •Pregnant and / or lactating women
研究组 & 干预措施
One arm only
干预措施: One arm only (Diagnostic Test)
结局指标
主要结局
The main objective of the study is to determine the concordance rate between molecular analysis of tumor tissue and that of cDNA in patients with endometrial cancer during treatment.
时间窗: 15 days
Concordance between molecular analysis of tumor tissue and that of cDNA, in patients with endometrial cancer during treatment
次要结局
- Analysis of the association of molecular anomalies on cDNA with clinical histological data.(15 days)
- Analysis of the association of molecular anomalies on cDNA and the amount of total circulating DNA to the radiological response in a metastatic situation.(3 months)