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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05310370
Other study ID # EOC-HRD3
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 26, 2022
Est. completion date March 26, 2025

Study information

Verified date March 2022
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone 86-139-1198-8831
Email lileigh@163.com
Is FDA regulated No
Health authority
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 has been investigated in previous studies (NCT04190667 and NCT04651920). This study is to investigate the correlation between HRD and the resistance to poly(ADP-ribose) polymerase inhibitors (PARPi) in a Chinese cohort confirmed of epithelial ovarian cancer. The mutated genes, HRD score model and their relationship with the prognosis is the primary endpoint in this study. All enrolled patients will accept PARPi as maintenance therapy after the complete or partial remission of targeted lesions. A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date March 26, 2025
Est. primary completion date March 26, 2024
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 - With detailed follow-up outcomes Exclusion Criteria: - Not meeting all of the inclusion criteria - Declining to accept PARPi as maintenance therapy after the major treatment for cancer

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
Testing of homologous recombination deficiency
A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.

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 Progression-free survival Progression-free survival after the start of PARPi One year
Secondary Overall survival Overall survival after the start of PARPi One year
Secondary Severe adverse events Severe adverse events after the start of PARPi One year
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