Homologous Recombination Deficiency Status in Epithelial Ovarian Cancer

• Conditions: BRCA1 Mutation; Chinese; Epithelial Ovarian Cancer; Homologous Recombination Deficiency; BRCA2 Mutation; Prognosis

• Registration Number: NCT04190667
• Lead Sponsor: Lei Li

Brief Summary

The homologous recombination deficiency (HRD) status in Chinese population with epithelial ovarian cancer (EOC) is little known. This study would recruit 1300 Chinese EOC patients. A multi-panel testing of 36 genes would be given for these patients in their peripheral blood and tumor tissues. These 36 genes include: BRCA1, BRCA2, ABRAXAS1(FAM175A）, ATM, ATR, BAP1, BARD1, BRIP1, C11ORF30（EMSY）, CDK12, CHEK1, CHEK2, FANCA, FANCC, FANCD2, FANCI, FANCL, MRE11A, NBN, PALB2, PPP2R2A, PTEN, RAD50, RAD51B, RAD51C, RAD51D, RAD54B, RAD54, MLH1, MSH2, MSH6, PMS2, EPCAM, STK11, TP53, CDH1. The study would select 150 patients with pathogenic or likely pathogenic mutations in BRCA1/2 and 150 patients without these mutations to further explore the HRD status. The HRD model 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-05
• Last Update Submitted: 2019-12-06
• Study Start: 2019-12-07
• Study First Posted: 2019-12-09
• Last Update Posted: 2019-12-10
• Primary Completion: 2021-12-07
• Study Completion: 2022-12-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of targeted genetic mutations	Two years	Frequency of pathogenic or likely pathogenic mutations in a multi-panel genes
Homologous recombination deficiency (HRD) score	Two years	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)

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Two years	Progression-free survival in recruited patients
Rate of sensitivity to platinum-based chemotherapy	Two years	Sensitivity to platinum-based chemotherapy in recruited patients
Overall survival	Two years	Overall survival in recruited patients
Rate of sensitivity to poly-(ADP-ribose) polymerase inhibitors	Two years	Sensitivity to poly-(ADP-ribose) polymerase inhibitors in recruited patients

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China