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

Yonsei University

Status: Enrolling

Conditions: Ovarian Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05640024

4-2022-1170

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: Female

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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