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

September 29, 2024 updated by: Jing Li, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

470

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HRD score
Time Frame: 2 years
Homologous recombination deficiency score
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Amoy Diagnostics Co., LTD

Investigators

  • Principal Investigator: Jing Li, M.D. Ph.D, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

July 7, 2026

Study Registration Dates

First Submitted

September 29, 2024

First Submitted That Met QC Criteria

September 29, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

September 29, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2024-218-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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