Prospective Cohort Study for Validation of Predictive Immune Biomarkers of Response to PAPR Inhibitors

Recruiting

• Conditions: Ovarian Cancer

• Registration Number: NCT05640024
• Lead Sponsor: Yonsei University

Brief Summary

Increasing number of ovarian cancer patients are receiving PARP inhibitor as maintenance therapy. Predictive factors to PARP inhibitor other than BRCA mutation or HRD status are unknown. Previous study, we analyzed the dynamic immunological changes in peripheral T cells during PARP inhibitor maintenance therapy and found predictive biomarkers. The purpose of this study is to prospectively validate the biomarkers for predicting response to PAPR inhibitors in ovarian cancer. We collect serial blood samples (before initiation of therapy and after 1, 3, and 6 months) in ovarian cancer patients who receive PARP inhibitor and analyze immunological characteristics of peripheral CD8 and regulatory T cells. Through assessment of the baseline properties and dynamic changes in T cells, we aim to validate the predictive biomarker and develope promising novel targets to enhancing survival outcomes of high-risk patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study Start: 2022-11-06
• Study First Submitted: 2022-11-25
• Study First Submitted QC: 2022-11-25
• Last Update Submitted: 2022-11-25
• Study First Posted: 2022-12-07
• Last Update Posted: 2022-12-07
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

1. Pathological diagnosis of epithelial ovarian cancer, 2. Presence of germline or somatic BRCA mutational status result, 3. Advanced or recurrent ovarian cancer patients who responded to their most recent platinum-based chemotherapy and plan to start PARPi (olaparib or niraparib) maintenance therapy.

Exclusion Criteria

1. Patients who refuse to participate, 2. Patients having difficulty understanding the protocol due to language barrier

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of biomarkers for predicting response to PAPR inhibitor	The primary endpont will be accessed 12 months after last patient registration.	Investigators will utilize baseline peripherap blood mononuclear cells (PBMCs) to validate predictive biomarkers to PARP inhibitor. Response to PAPR inhibitor was defined by BRCA1/2 status and duration of PAPR inhibitor treatment.

Secondary Outcome Measures

Name	Time	Method
Identify promising novel targets to enhance survivla outcomes of high-risk pateints in PAPR inhibitor therapy.	Identify promising novel targets (Time Frame: 12 months)	Investigators will utilize serial samples to identify dynamic immunological changes during PAPR inhibitor therapy.
Identify dynamic immunological changes during PAPR inhibitor therapy	Immunological changes (Time Frame: 6 months	Investigators will utilize serial samples to identify dynamic immunological changes during PAPR inhibitor therapy.

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of