A Study on Association Between HR Genes and the HRD Status in Chinese Epithelial Ovarian Cancer

Completed

• Conditions: Homologous Recombination Deficiency; Epithelial Ovarian Cancer; Chinese; BRCA2 Mutation; Prognosis; Homologous Recombination Genes; BRCA1 Mutation
• Interventions: Genetic: Evaluation of homologous recombination deficiency score

• Registration Number: NCT04651920
• Lead Sponsor: Lei Li

Brief Summary

The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients is little known. This study would recruit 400 Chinese EOC patients with known targeted gene mutations via a multi-panel testing of 27 genes, including BRCA1/BRCA2. All patients accept evaluation of HRD model, which is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). 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
• Study First Posted: 2020-12-03
• Status Verified: 2021-03
• Primary Completion: 2022-03-26
• Study Completion: 2022-03-26
• Last Update Submitted: 2022-03-26
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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	Evaluation of homologous recombination deficiency score	-
Epithelial ovarian cancer patients resistant to platinum based chemotherapy	Evaluation of homologous recombination deficiency score	-

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 three types of important molecular mechanism: loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). 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
Overall survival	Five years	Overall survival in recruited patients
Progression-free survival	Five years	Progression-free survival in recruited patients

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China