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Trial Title:
Prospective Cohort Study for Validation of Predictive Immune Biomarkers of Response to PAPR Inhibitors
NCT ID:
NCT05640024
Condition:
Ovarian Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Ovarian cancer patients who receive PARP inhibitor
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
19 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yonsei University Health System, Severance Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jung-Yun Lee
Phone:
82-2-2228-2237
Email:
jungyunlee@yuhs.ac
Start date:
November 6, 2022
Completion date:
October 30, 2025
Lead sponsor:
Agency:
Yonsei University
Agency class:
Other
Source:
Yonsei University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05640024
