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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04651920
• Other study ID #: EOC-HRD2
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

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

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