A Training Set for the HRD Model in EOC

• Conditions: Epithelial Ovarian Cancer; BRCA Mutation; Homologous Recombination Deficiency; Loss of Heterozygosity; Prognosis; Platinum Resistance
• Interventions: Genetic: Homologous recombination deficiency model

• Registration Number: NCT04651933
• Lead Sponsor: Lei Li

Brief Summary

A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH) is little explored in epithelial ovarian cancer (EOC) patients. This study would recruit 200 Chinese EOC patients with known BRCA1/2 mutation status and resistance to platinum-based chemotherapy. A LOH-HRD model is to be constructed based on the genetic testing in these patients. The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients, and a potential explanation of platinum-resistance in such population.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-26
• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-11-26
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-02
• Study First Posted: 2020-12-03
• Last Update Posted: 2020-12-04
• Primary Completion: 2022-11-26
• Study Completion: 2022-11-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Aged 18 years or older
• Pathological confirmation of epithelial ovarian cancer
• With available tumor tissues
• Given consents to participate the study

Exclusion Criteria

• Not meeting all of the inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epithelial ovarian cancer patients sensitive to platinum based chemotherapy	Homologous recombination deficiency model	-
Epithelial ovarian cancer patients resistant to platinum based chemotherapy	Homologous recombination deficiency model	-

Primary Outcome Measures

Name	Time	Method
Homologous recombination deficiency (HRD) score	Two years	The HRD score for individual patient is a scale describing her HRD status. The score model is calculated by the analysis for loss of heterozygosity (LOH), and the minimum value is 0, but the maximun value is not available. Higher scores mean more sensitivity to poly-ADP-ribose polymerase inhibitor

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Five years	Progression-free survival in recruited patients
Overall survival	Five years	Overall survival in recruited patients

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China