Homologous Recombination Deficiency Status in Epithelial Ovarian Cancer

Epithelial Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04190667
• Other study ID #: EOC-HRD
• Status: Recruiting
• Start date: December 7, 2019
• Est. completion date: December 7, 2022

Study information

• Verified date: December 2019
• Source: Peking Union Medical College Hospital
• Contact: Lei Li
• Phone: +8613911988831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: December 7, 2022
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: No
• 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
• Ovarian Neoplasms
• Prognosis

Intervention

Diagnostic Test:
• Genomic testing
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.

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	Frequency of targeted genetic mutations	Frequency of pathogenic or likely pathogenic mutations in a multi-panel genes	Two years
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)	Two years
Secondary	Progression-free survival	Progression-free survival in recruited patients	Two years
Secondary	Overall survival	Overall survival in recruited patients	Two years
Secondary	Rate of sensitivity to platinum-based chemotherapy	Sensitivity to platinum-based chemotherapy in recruited patients	Two years
Secondary	Rate of sensitivity to poly-(ADP-ribose) polymerase inhibitors	Sensitivity to poly-(ADP-ribose) polymerase inhibitors in recruited patients	Two years