HRD Status Reference Standard Based on WGS

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT06490380
• Lead Sponsor: Lei Li

Brief Summary

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.

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 Timeline

• Study Start: 2022-12-30
• Primary Completion: 2023-12-13
• Status Verified: 2024-06
• Study Completion: 2024-06-21
• Study First Submitted: 2024-06-30
• Study First Submitted QC: 2024-06-30
• Last Update Submitted: 2024-06-30
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival	Up to 42 months	Time from first dose of PARPi to disease progression or death, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Overall survival	Up to 48 months	Time from first dose of PARPi to death.

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China