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

Sponsor
Lei Li (Other)
Overall Status
Completed
CT.gov ID
NCT04651920
Collaborator
(none)
240
1
15.9
15.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Evaluation of homologous recombination deficiency score

Study Design

Study Type:
Observational
Actual Enrollment :
240 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
A Study on Association Between Homologous Recombination Genes and the Homologous Recombination Deficiency Status in Chinese Population With Epithelial Ovarian Cancer
Actual Study Start Date :
Nov 26, 2020
Actual Primary Completion Date :
Mar 26, 2022
Actual Study Completion Date :
Mar 26, 2022

Arms and Interventions

Arm Intervention/Treatment
Epithelial ovarian cancer patients sensitive to platinum based chemotherapy

Genetic: Evaluation of homologous recombination deficiency score
Evaluation of homologous recombination deficiency score which is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST)

Epithelial ovarian cancer patients resistant to platinum based chemotherapy

Genetic: Evaluation of homologous recombination deficiency score
Evaluation of homologous recombination deficiency score which is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Progression-free survival [Five years]

    Progression-free survival in recruited patients

  2. Overall survival [Five years]

    Overall survival in recruited patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lei Li Beijing Beijing China 100730

Sponsors and Collaborators

  • Lei Li

Investigators

  • Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT04651920
Other Study ID Numbers:
  • EOC-HRD2
First Posted:
Dec 3, 2020
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022