A Training Set for the HRD Model in EOC

Overview

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.

Full Title of Study: “A Training Set for the Homologous Recombination Deficiency Scoring Model With Loss of Heterozygosity Status in Epithelial Ovarian Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: November 26, 2022

Interventions

  • Genetic: Homologous recombination deficiency model
    • A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH)

Arms, Groups and Cohorts

  • Epithelial ovarian cancer patients sensitive to platinum based chemotherapy
  • Epithelial ovarian cancer patients resistant to platinum based chemotherapy

Clinical Trial Outcome Measures

Primary Measures

  • 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 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 Measures

  • Progression-free survival
    • Time Frame: Five years
    • Progression-free survival in recruited patients
  • Overall survival
    • Time Frame: Five years
    • Overall survival in recruited patients

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lei Li
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Lei Li, Professor – Peking Union Medical College Hospital
  • Overall Official(s)
    • Lei Li, M.D., Principal Investigator, Peking Union Medical College Hospital
  • Overall Contact(s)
    • Lei Li, M.D., +8613911988831, lileigh@163.com

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