RecruitingNCT06622798

Exploratory Study on the Correlation Between HRD Score and PARPi Efficacy Based on Chinese Ovarian Cancer Patients

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


Sponsor

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

Enrollment

470 participants

Start Date

Aug 20, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria4

  • 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.

Interventions

OTHERNon-interventional

Non-interventional


Locations(1)

Sun Yat-sen memorial hospital

Guangzhou, Guangdong, China

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NCT06622798