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

NCT05640024 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2022-12-07

No results posted yet for this study

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Jung-Yun Lee · Yonsei University College of Medicine Department of Obstetrics and Gynecology

Eligibility

Min Age
19 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-06
Primary Completion
2025-10-30
Completion
2025-10-30

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05640024 on ClinicalTrials.gov