NCT06490380已完成不适用
A Collaborative Project Aimed to Establish a WGS-based Reference Standard for Evaluating the Analytical Performance of HRD Status Testing
Lei Li1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年12月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
When evaluating the analytical performance of homologous recombination deficiency (HRD) status testing, there is currently no widely accepted reference standard. Therefore, a collaborative project was initiated to establish a HRD status reference standard for the industry. Although there is no genotyping strategy that is universally recognized as the most accurate for evaluating HRD status, whole-genome sequencing (WGS) is one of the best candidates.
详细描述
- Primary objective: To establish a HRD status reference standard based on WGS.
- Secondary objective: To validate the analytical performance of panel HRD status using WGS HRD status as reference standard.
- Exploratory objective 1: To explore how methylation of selective genes correlate with WGS HRD status and efficacy.
- Exploratory objective 2: To explore how HRR gene mutations correlate with WGS HRD status and efficacy.
- Exploratory objective 3: To set up a harmonized bioinformatic analysis workflow for WGS HRD status.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •At least 18 years of age at diagnosis
- •Ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- •High-grade serous or high-grade endometroid histological type
- •FIGO stage II, III, or IV
- •Complete response or partial response following completion of first-line adjuvant chemotherapy
- •PARPi administered as first-line maintenance therapy
排除标准
- •First-line surgery not conducted
- •Total round of first-line chemotherapy (neoadjuvant and adjuvant) less than 5
- •First-line PARPi maintenance therapy initiated beyond 12 weeks after last dose of chemotherapy
- •Genotyping quality-control failed
结局指标
主要结局
Progression-free survival
时间窗: Up to 42 months
Time from first dose of PARPi to disease progression or death, whichever occurs first.
次要结局
- Overall survival(Up to 48 months)
研究者
Lei Li
Professor
Peking Union Medical College Hospital
研究点 (1)
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