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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2021
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Genetic:
Evaluation 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)

Locations

Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

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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