HRD Status Reference Standard Based on WGS

A Collaborative Project Aimed to Establish a WGS-based Reference Standard for Evaluating the Analytical Performance of HRD Status Testing

When evaluating the analytical performance of homologous recombination deficiency (HRD) status testing, there is currently no widely accepted reference standard. Therefore, a collaborative project was initiated to establish a HRD status reference standard for the industry. Although there is no genotyping strategy that is universally recognized as the most accurate for evaluating HRD status, whole-genome sequencing (WGS) is one of the best candidates.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: PARPi

Detailed Description

• Primary objective: To establish a HRD status reference standard based on WGS.
• Secondary objective: To validate the analytical performance of panel HRD status using WGS HRD status as reference standard.
• Exploratory objective 1: To explore how methylation of selective genes correlate with WGS HRD status and efficacy.
• Exploratory objective 2: To explore how HRR gene mutations correlate with WGS HRD status and efficacy.
• Exploratory objective 3: To set up a harmonized bioinformatic analysis workflow for WGS HRD status.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Lei Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Ovarian cancer patients received first-line PARPi maintenance therapy

Description

Inclusion Criteria:

• At least 18 years of age at diagnosis
• Ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
• High-grade serous or high-grade endometroid histological type
• FIGO stage II, III, or IV
• Complete response or partial response following completion of first-line adjuvant chemotherapy
• PARPi administered as first-line maintenance therapy

Exclusion Criteria:

• First-line surgery not conducted
• Total round of first-line chemotherapy (neoadjuvant and adjuvant) less than 5
• First-line PARPi maintenance therapy initiated beyond 12 weeks after last dose of chemotherapy
• Genotyping quality-control failed

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Time from first dose of PARPi to disease progression or death, whichever occurs first.	Up to 42 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Time from first dose of PARPi to death.	Up to 48 months

Collaborators and Investigators

• Sponsor: Lei Li
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences; National Institutes for Food and Drug Control, China

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2022
• Primary Completion (Actual): December 13, 2023
• Study Completion (Actual): June 21, 2024

Study Registration Dates

• First Submitted: June 30, 2024
• First Submitted That Met QC Criteria: June 30, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: June 30, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HRDref-WGS

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