NCT05640024

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 54 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: Female
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer

Timeline

• Start date: 2022-11-06
• Primary completion: 2025-10-30
• Completion: 2025-10-30
• First posted: 2022-12-07
• Last updated: 2022-12-07

Locations

1 site across 1 country: South Korea