Test validation for HRD detection using NGS methodology

• Conditions: G05.728.615; Ovarian Neoplasms

• Registration Number: RBR-8nwxhs4
• Lead Sponsor: Oncoclinicas do Brasil Serviços Médicos S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-18
• Last Update Posted: 16 October 2023
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Patients > 18 years old; diagnosed with high grade serous ovarian cancer; platinum-sensitive; mutant or wild type for germline or somatic HRR genes based on OCPM Next Generation Sequencing (NGS) panels.

Exclusion Criteria

Patient that do not accept to sign the informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This is a retrospective cohort study conducted at the Oncoclínicas Precision Medicine laboratory facilities to technically validate a new HRD test. Specifically, this study aims to verify the concordance of the QIAseq HRD Panel (QIAGEN) with the gold standard HRD test myChoice CDx (Myriad Genetics). As an exploratory objective, we will assess the clinical impact of HRD test results by stratifying patients according to response status to platinum-based regimen and/or PARPi therapy.

Secondary Outcome Measures

Name	Time	Method
o secondary outcomes are expected