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Test validation for HRD detection using NGS methodology

Homologous recombination deficiency (HRD) test validation by NGS methodology at Oncoclínicas Precision Medicine laboratory in Brazil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-8nwxhs4
Enrollment
Unknown
Registered
2023-09-18
Start date
2023-10-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Neoplasms

Interventions

We will investigate samples from 40 patients with advanced or relapsed platinum-sensitive ovarian cancer in retrospective cohort. This is a retrospective cohort study conducted at the Oncoclínicas Pre
V03.175.500

Sponsors

Oncoclinicas do Brasil Serviços Médicos S.A
Lead Sponsor
LOCUS - Anatomia Patologia e Citologia LTDA
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: Patient that do not accept to sign the informed consent

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
No secondary outcomes are expected

Countries

Brazil

Contacts

Public ContactLeandro Camara

Oncoclinicas do Brasil Serviços Médicos S.A

leandro.camara@oncoclinicas.com+55 (21) 2127 0447

Outcome results

None listed

Source: REBEC (via WHO ICTRP)