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临床试验/NCT04651920
NCT04651920已完成不适用

A Study on Association Between Homologous Recombination Genes and the Homologous Recombination Deficiency Status in Chinese Population With Epithelial Ovarian Cancer

Lei Li1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2020年11月26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
240
试验地点
1
主要终点
Homologous recombination deficiency (HRD) score

研究概览

简要总结

The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients is little known. This study would recruit 400 Chinese EOC patients with known targeted gene mutations via a multi-panel testing of 27 genes, including BRCA1/BRCA2. All patients accept evaluation of HRD model, which is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients, and a potential explanation of platinum-resistance in such population.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged 18 years or older
  • Pathological confirmation of epithelial ovarian cancer
  • With available tumor tissues
  • Given consents to participate the study

排除标准

  • Not meeting all of the inclusion criteria

结局指标

主要结局

Homologous recombination deficiency (HRD) score

时间窗: Two years

The HRD score for individual patient is a scale describing her HRD status. The score model is calculated by the analysis for three types of important molecular mechanism: loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). The minimum value is 0, but the maximun value is not available. Higher scores mean more sensitivity to poly-ADP-ribose polymerase inhibitor.

次要结局

  • Overall survival(Five years)
  • Progression-free survival(Five years)

研究者

发起方
Lei Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lei Li

Professor

Peking Union Medical College Hospital

研究点 (1)

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