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UnknownNCT04190667

Homologous Recombination Deficiency Status in Epithelial Ovarian Cancer

A Study on the Homologous Recombination Deficiency Status in Chinese Population With Epithelial Ovarian Cancer

Status
Unknown
Phase
Study type
Observational
Enrollment
1,300 (estimated)
Sponsor
Lei Li · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTGenomic testingA 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.

Timeline

Start date
2019-12-07
Primary completion
2021-12-07
Completion
2022-12-07
First posted
2019-12-09
Last updated
2019-12-10

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT04190667. Inclusion in this directory is not an endorsement.