A Study on the Homologous Recombination Deficiency Status in Chinese Population With Epithelial Ovarian Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Frequency of targeted genetic mutations
研究概览
简要总结
The homologous recombination deficiency (HRD) status in Chinese population with epithelial ovarian cancer (EOC) is little known. This study would recruit 1300 Chinese EOC patients. A multi-panel testing of 36 genes would be given for these patients in their peripheral blood and tumor tissues. These 36 genes include: BRCA1, BRCA2, ABRAXAS1(FAM175A）, ATM, ATR, BAP1, BARD1, BRIP1, C11ORF30（EMSY）, CDK12, CHEK1, CHEK2, FANCA, FANCC, FANCD2, FANCI, FANCL, MRE11A, NBN, PALB2, PPP2R2A, PTEN, RAD50, RAD51B, RAD51C, RAD51D, RAD54B, RAD54, MLH1, MSH2, MSH6, PMS2, EPCAM, STK11, TP53, CDH1. The study would select 150 patients with pathogenic or likely pathogenic mutations in BRCA1/2 and 150 patients without these mutations to further explore the HRD status. The HRD model 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.
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
- •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
Frequency of targeted genetic mutations
时间窗: Two years
Frequency of pathogenic or likely pathogenic mutations in a multi-panel genes
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)
次要结局
- Progression-free survival(Two years)
- Rate of sensitivity to platinum-based chemotherapy(Two years)
- Overall survival(Two years)
- Rate of sensitivity to poly-(ADP-ribose) polymerase inhibitors(Two years)
研究者
Lei Li
Professor
Peking Union Medical College Hospital