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

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05640024
Collaborator
(none)
54
Enrollment
1
Location
35.8
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    54 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Prospective Cohort Study for Validation of Predictive Immune Biomarkers of Response to PAPR Inhibitors
    Actual Study Start Date :
    Nov 6, 2022
    Anticipated Primary Completion Date :
    Oct 30, 2025
    Anticipated Study Completion Date :
    Oct 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Validation of biomarkers for predicting response to PAPR inhibitor [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.

    Secondary Outcome Measures

    1. Identify dynamic immunological changes during PAPR inhibitor therapy [Immunological changes (Time Frame: 6 months]

      Investigators will utilize serial samples to identify dynamic immunological changes during PAPR inhibitor therapy.

    2. Identify promising novel targets to enhance survivla outcomes of high-risk pateints in PAPR inhibitor therapy. [Identify promising novel targets (Time Frame: 12 months)]

      Investigators will utilize serial samples to identify dynamic immunological changes during PAPR inhibitor therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 85 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yonsei University Health System, Severance Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT05640024
    Other Study ID Numbers:
    • 4-2022-1170
    First Posted:
    Dec 7, 2022
    Last Update Posted:
    Dec 7, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Dec 7, 2022