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

Study Overview
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Brief Summary
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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.

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

Conditions
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Epithelial Ovarian Cancer, Chinese, Homologous Recombination Deficiency, BRCA1 Mutation, BRCA2 Mutation, Prognosis, Homologous Recombination Genes

Intervention / Treatment
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* Genetic: Evaluation of homologous recombination deficiency score


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epithelial ovarian cancer patients sensitive to platinum based chemotherapy<br> | Genetic: Evaluation of homologous recombination deficiency score<br>* 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)<br>|
| Epithelial ovarian cancer patients resistant to platinum based chemotherapy<br> | Genetic: Evaluation of homologous recombination deficiency score<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival in recruited patients | Five years | 
| Overall survival | Overall survival in recruited patients | Five years |