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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05640024
• Other study ID #: 4-2022-1170
• Status: Recruiting
• Start date: November 6, 2022
• Est. completion date: October 30, 2025

Study information

• Verified date: November 2022
• Source: Yonsei University
• Contact: Jung-Yun Lee
• Phone: 82-2-2228-2237
• Email: jungyunlee[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of biomarkers for predicting response to PAPR inhibitor	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.	The primary endpont will be accessed 12 months after last patient registration.
Secondary	Identify dynamic immunological changes during PAPR inhibitor therapy	Investigators will utilize serial samples to identify dynamic immunological changes during PAPR inhibitor therapy.	Immunological changes (Time Frame: 6 months
Secondary	Identify promising novel targets to enhance survivla outcomes of high-risk pateints in PAPR inhibitor therapy.	Investigators will utilize serial samples to identify dynamic immunological changes during PAPR inhibitor therapy.	Identify promising novel targets (Time Frame: 12 months)