Exploring the link between HRD scores and PARPi effectiveness in Chinese ovarian cancer patients
A Retrospective Study Exploring the Correlation Between HRD Score and PARPi Efficacy Based on Chinese Ovarian Cancer Patients
This study is trying to see if a special scoring system for genetic changes can help doctors better understand how well a certain treatment works for Chinese patients with advanced ovarian cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 470 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06622798 on ClinicalTrials.gov |
What this trial studies
This observational study aims to retrospectively analyze 470 surgical specimens from patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancers who received PARPi maintenance therapy. The study will utilize the proprietary HRD ADx-GSS® algorithm to assess genomic statuses such as heterozygous omission, telomere allelic imbalance, and large-segment translocation. By correlating HRD scores with patient prognosis and treatment outcomes, the study seeks to establish standardized HRD scoring methods in China, which could enhance treatment personalization for ovarian cancer patients.
Who should consider this trial
Good fit: Ideal candidates include female patients aged 18 and older with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancers who have undergone PARPi maintenance therapy.
Not a fit: Patients with other malignancies within the last five years or those with severely compromised health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for ovarian cancer patients by identifying those most likely to benefit from PARPi therapy.
How similar studies have performed: Previous studies have indicated that HRD scores can predict responses to PARPi therapy, suggesting that this approach has potential based on existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen memorial hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Jing Li, M.D. Ph.D — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Jing Li, M.D. Ph.D
- Email: lijing228@mail.sysu.edu.cn
- Phone: 15915893493
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.