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CompletedNCT04651920Updated Mar 29, 2022

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

An observational study in Epithelial Ovarian Cancer, Chinese and Homologous Recombination Deficiency, sponsored by Lei Li. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-29.

Sponsored by Lei Li · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
240
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Epithelial Ovarian Cancer
  • Chinese
  • Homologous Recombination Deficiency
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Prognosis
  • Homologous Recombination Genes
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 240 is above the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Lei Li is the lead sponsor of 60 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Chinese population with confirmed diagnosis of epithelial ovarian cancer with known targeted gene mutations via a multi-panel testing of 27 genes and known resistance to platinum-based chemotherapy

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

Exclusion Criteria:

  • Not meeting all of the inclusion criteria
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
240 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Epithelial ovarian cancer patients sensitive to platinum based chemotherapy

    Genetic: Evaluation of homologous recombination deficiency score

  • Epithelial ovarian cancer patients resistant to platinum based chemotherapy

    Genetic: Evaluation of homologous recombination deficiency score

Interventions

  • GeneticEvaluation 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)

06

What researchers measure

Primary outcomes

  1. Homologous recombination deficiency (HRD) score

    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.

    Time frame: Two years

Secondary outcomes

  1. Progression-free survival

    Progression-free survival in recruited patients

    Time frame: Five years

  2. Overall survival

    Overall survival in recruited patients

    Time frame: Five years

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Study locations

1 site
  • Lei Li
    Beijing, Beijing 100730, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04651920
Lead sponsor
Lei Li
Responsible party
Lei Li (Professor, Peking Union Medical College Hospital) — Sponsor-investigator
First posted
Dec 3, 2020
Start date
Nov 26, 2020
Primary completion
Mar 26, 2022
Completion
Mar 26, 2022
Last update
Mar 29, 2022

Study contacts

Lei Li, M.D.
principal investigator · Peking Union Medical College Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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