Ignite Creation Date:
2024-07-17 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490380
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2024-06-30
Brief Title:
HRD Status Reference Standard Based on WGS
Sponsor:
Lei Li
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Collaborative Project Aimed to Establish a WGS-based Reference Standard for Evaluating the Analytical Performance of HRD Status Testing
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None