HRD and Resistance to PAPPi in EOC Patients

Recruiting

• Conditions: Drug Resistance; Poly(ADP-ribose) Polymerase Inhibitor; Progression-free Survival; Overall Survival; Epithelial Ovarian Cancer; Homologous Recombination Deficiency; Homologous Recombination Repair Gene Mutation

• Registration Number: NCT05310370
• Lead Sponsor: Lei Li

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-26
• Study First Submitted: 2022-03-26
• Study First Submitted QC: 2022-03-26
• Last Update Submitted: 2022-03-26
• Study First Posted: 2022-04-04
• Last Update Posted: 2022-04-04
• Primary Completion: 2024-03-26
• Study Completion: 2025-03-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival	One year	Progression-free survival after the start of PARPi

Secondary Outcome Measures

Name	Time	Method
Overall survival	One year	Overall survival after the start of PARPi
Severe adverse events	One year	Severe adverse events after the start of PARPi

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China