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临床试验/NCT06622798
NCT06622798招募中不适用

A Retrospective Study Exploring the Correlation Between HRD Score and PARPi Efficacy Based on Chinese Ovarian Cancer Patients

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 470 人开始时间: 2024年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
470
试验地点
1
主要终点
HRD score

研究概览

简要总结

This study plans to retrospectively include 470 initial surgical specimens from 470 patients with epithelial ovarian, fallopian tube or primary peritoneal cancers who were treated with PARPi maintenance therapy in the hospital from 2018.01 to 2024.01. All patients included would be scored by the proprietary HRD ADx-GSS® algorithm with the detecting results of the three genomic statuses including heterozygous omission (LOH), telomere allelic imbalance (TAI), and large-segment translocation (LST). Finally, the correlation between the HRD scores and the prognosis of Chinese ovarian cancer patients and the efficacy of using PARPi as maintenance treatment would be explored.

详细描述

Although most advanced ovarian cancers achieve clinical remission after conventional initial treatment, the recurrence rate is still high in clinics. Poly ADP-ribose polymerase inhibitor (PARPi) is widely used in the maintenance treatment of ovarian cancer after chemotherapy to prolong the time to recurrence, and its main mechanism is to inhibit the repair of single-stranded DNA damage in tumour cells, which is synthetically lethal in the tumour cells with mutations in the BRCA1/2 gene. Numerous studies have shown that homologous recombination deficiency (HRD) exists in about 50% of epithelial ovarian cancer patients, and has been confirmed to be a predictor of ovarian cancer patients' response to PARPi therapy. However, up to now, there is still no uniform scoring and threshold standard for HRD detection in China. With the increasing attention of HRD detection in clinical diagnosis and treatment, acknowledged standards of HRD scoring algorithms and thresholds are essential. Using a retrospective. Thus, this observational and retrospective study intends to enroll 470 patients with epithelial ovarian, fallopian tube or primary peritoneal cancers who were treated with PARPi maintenance therapy in the hospital from 2018.01 to 2024.01. All patients included would be scored by the proprietary HRD ADx-GSS® algorithm with the detecting results of the three genomic statuses including heterozygous omission (LOH), telomere allelic imbalance (TAI), and large-segment translocation (LST). Finally, the correlation between the HRD scores and the prognosis of Chinese ovarian cancer patients and the efficacy of using PARPi as maintenance treatment would be explored.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer initially diagnosed after January 2015 or platinum-sensitive recurrent patients diagnosed with advanced epithelial ovarian, fallopian tube, and primary peritoneal cancers, and are treated with PARPi maintenance therapy by January 2024 after chemotherapy or Platinum-sensitive recurrent patients diagnosed with advanced epithelial ovarian, fallopian tube, and primary peritoneal cancers, and are treated with PARPi maintenance therapy by January 2024 after chemotherapy;
  • Age ≥ 18 years, female;
  • Stable CA125 level, ECOG: 0-2 points, and appropriate cardiac, liver and renal function before using PARPi.

排除标准

  • other malignancies combined within 5 years;
  • poor underlying condition, one of the following: ECOG PS score >2, KPS score <60, cardiac insufficiency (Class III-IV), hepatic insufficiency (Child-Pugh Class C), renal insufficiency (Stage 4-5);
  • patients whose sample residuals and quality do not support the need for testing;
  • conditions that, in the judgement of the investigator, may affect the conduct of the clinical study and the determination of the study results.

结局指标

主要结局

HRD score

时间窗: 2 years

Homologous recombination deficiency score

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jing Li

Associate chief physician

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (1)

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