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Clinical Trials/NCT04651920
NCT04651920
Completed
Not Applicable

A Study on Association Between Homologous Recombination Genes and the Homologous Recombination Deficiency Status in Chinese Population With Epithelial Ovarian Cancer

Lei Li1 site in 1 country240 target enrollmentNovember 26, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epithelial Ovarian Cancer
Sponsor
Lei Li
Enrollment
240
Locations
1
Primary Endpoint
Homologous recombination deficiency (HRD) score
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 26, 2020
End Date
March 26, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Lei Li
Responsible Party
Sponsor Investigator
Principal Investigator

Lei Li

Professor

Peking Union Medical College Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Homologous recombination deficiency (HRD) score

Time Frame: 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 Outcomes

  • Overall survival(Five years)
  • Progression-free survival(Five years)

Study Sites (1)

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