NCT06490380

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Lei Li · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	PARPi	Poly(adenosine diphosphate-ribose) polymerase inhibitor (PARPi)

Timeline

• Start date: 2022-12-30
• Primary completion: 2023-12-13
• Completion: 2024-06-21
• First posted: 2024-07-08
• Last updated: 2024-07-08

Locations

1 site across 1 country: China