跳至主要内容
临床试验/NCT05334303
NCT05334303Unknown不适用

Prevalence and Prognostic Impact of Epigenetic MMRd in Endometrial Carcinomas

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University0 个研究点目标入组 400 人开始时间: 2022年11月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
主要终点
Proportion of MMRd caused by MLH1 promoter methylation in endometrial carcinoma

研究概览

简要总结

In recent years, the incidence of endometrial carcinoma (EC) has increased significantly and patients tends to be younger. In addition to known risk factors such as obesity, hypertension and diabetes, genetic factors also play an important role in the occurrence and development of EC. Among them, Mismatch Repair Defect (MMR) can produce mutant phenotypes, leading to cancer susceptibility. Although some articles indicated that epigenetic MMRd, one type of MMRd, predicted poor prognosis among endometrial carcinoma patients, hitherto, the clinicopathological significance and prognosis of epigenetic MMRd has not been determined. To date, there are no relevant large-sample data to investigate the prevalence of epigenetic MMRd in Chinese population, as well as the impact on the prognosis of endometrial cancer. In this setting, The purpose of this study was to investigate the prevalence of epigenetic MMRd and its impact on clinicopathology and prognosis on endometrial cancer among Chinese patients.

详细描述

We conducted a retrospective real-world study of all endometrial carcinoma cases from 2019 to 2022. The inclusion criterion is all patients diagnosed with endometrial cancer in our hospital from 2019 to 2022 and exclusion criteria are those without histological specimens in our hospital. After immunohistochemistry and MLH1-promoter methylation testing, tumors were classified into 3 groups according to status of mismatch repair defects. Tumors with MMR abnormalities by IHC and MLH1 methylation were classified as epigenetic MMR deficiency while those without MLH1 methylation were classified as probable MMR mutations, and those without MMRd were classified as MMR proficient. The first outcome is the prevalence of epigenetic MMRd in endometrial cancer, and the second outcome is Whether the clinicopathological features and prognosis of endometrioid adenocarcinoma differ between the epigenetic MMRd population, MMR proficient population and the Lynch/ Lynch-like population.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • all patients diagnosed with endometrial cancer in our hospital from 2019 to 2022

排除标准

  • those without histological specimens in our hospital

结局指标

主要结局

Proportion of MMRd caused by MLH1 promoter methylation in endometrial carcinoma

时间窗: up to two years

the prevalence of epigenetic MMRd in endometrial cancer

次要结局

  • progression-free survival time (PFS)(up to two years)

研究者

申办方类型
Other
责任方
Sponsor

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