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

November 25, 2022 updated by: Yonsei University
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei University Health System, Severance Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Ovarian cancer patients who receive PARP inhibitor

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of biomarkers for predicting response to PAPR inhibitor
Time Frame: 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.
The primary endpont will be accessed 12 months after last patient registration.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Jung-Yun Lee, Yonsei University College of Medicine Department of Obstetrics and Gynecology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2022

Primary Completion (Anticipated)

October 30, 2025

Study Completion (Anticipated)

October 30, 2025

Study Registration Dates

First Submitted

November 25, 2022

First Submitted That Met QC Criteria

November 25, 2022

First Posted (Estimate)

December 7, 2022

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

November 25, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 4-2022-1170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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