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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04651920
Enrollment
240
Registered
2020-12-03
Start date
2020-11-26
Completion date
2022-03-26
Last updated
2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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)

Sponsors

Lei Li
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Homologous recombination deficiency (HRD) scoreTwo yearsThe 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

MeasureTime frameDescription
Overall survivalFive yearsOverall survival in recruited patients
Progression-free survivalFive yearsProgression-free survival in recruited patients

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026