跳至主要内容
临床试验/NCT05255861
NCT05255861招募中不适用

An Exploratory Study of HRD Score in Chinese Ovarian Cancer Patients Benefiting From PARP Inhibitor Targeted Therapy

Xin Wu1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Homologous Recombination Deficiency score

研究概览

简要总结

This project intends to evaluate the sensitivity of different Homologous Recombination Deficiency (HRD) score to Poly(ADP-ribose) polymerase inhibitor (PARPi) by retrospectively analyzing the tissue samples of patients with ovarian cancer using PARPi, and to determine the cut off value of the HRD score algorithm suitable for the Chinese population, so as to provide evidence for the role of PARPi in ovarian cancer. The screening of the beneficiaries of maintenance therapy provides precise guidance and can be used as a reference for other cancer types.

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 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • age ≥ 18 years;
  • high-grade serous/endometrioid epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer;
  • FIGO stage III or IV;
  • at least 6 cycles and no more than 9 cycles First-line platinum-containing chemotherapy;
  • CR or PR after chemotherapy;
  • sufficient biological samples for HRD score detection;
  • patients signed informed consent;
  • good bone marrow function.

排除标准

  • incomplete follow-up records of survival information;
  • unqualified biological sample quality control

结局指标

主要结局

Homologous Recombination Deficiency score

时间窗: After the ovarian tissue is obtained, an average of 3 year

Optimize the Homologous Recombination Deficiency scoring algorithm to calculate the Homologous Recombination Deficiency score of each patient's ovarian cancer tissue

次要结局

未报告次要终点

研究者

发起方
Xin Wu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xin Wu

Department Director

Obstetrics & Gynecology Hospital of Fudan University

研究点 (1)

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