Epithelial Ovarian Cancer Clinical Trial
Official title:
A Study on Association Between Homologous Recombination Genes and the Homologous Recombination Deficiency Status in Chinese Population With Epithelial Ovarian Cancer
NCT number | NCT04651920 |
Other study ID # | EOC-HRD2 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 26, 2020 |
Est. completion date | March 26, 2022 |
Verified date | March 2021 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 240 |
Est. completion date | March 26, 2022 |
Est. primary completion date | March 26, 2022 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Lei Li | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Lei Li |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Progression-free survival | Progression-free survival in recruited patients | Five years | |
Secondary | Overall survival | Overall survival in recruited patients | Five years |
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