NCT06622798 Exploratory Study on the Correlation Between HRD Score and PARPi Efficacy Based on Chinese Ovarian Cancer Patients

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 470 participants in total. It began in 2024-08-20 with a primary completion date of 2025-01-01.

Brief 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 Criteria

Inclusion Criteria: 1. 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; 2. Age ≥ 18 years, female; 3. Stable CA125 level, ECOG: 0-2 points, and appropriate cardiac, liver and renal function before using PARPi. Exclusion Criteria: 1. other malignancies combined within 5 years; 2. 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); 3. patients whose sample residuals and quality do not support the need for testing; 4. conditions that, in the judgement of the investigator, may affect the conduct of the clinical study and the determination of the study results.

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