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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04190667
Other study ID # EOC-HRD
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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