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NCT Number: NCT04651920

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

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.

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases BRCA1 Mutation BRCA2 Mutation Carcinoma Carcinoma, Ovarian Epithelial Chinese Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Homologous Recombination Deficiency Homologous Recombination Genes Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Prognosis Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Lei Li

Beijing, Beijing Municipality, 100730, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of homologous recombination deficiency score

Genetic

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)

Primary outcomes

  1. 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

  1. Progression-free survival

    Time frame: Five years

    Progression-free survival in recruited patients

  2. Overall survival

    Time frame: Five years

    Overall survival in recruited patients

Sponsors and collaborators

Lead sponsor

Lei Li

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 3, 2020
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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