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COMPLETED
NCT07684846
NA

Longitudinal Plasma Proteomic Remodeling in Ovarian Cancer

Sponsor: University Medical Centre Ljubljana

View on ClinicalTrials.gov

Summary

This longitudinal observational study investigates treatment-associated changes in the circulating plasma proteome of patients with ovarian cancer undergoing standard treatment. Although CA125 and HE4 are established biomarkers for monitoring treatment response, they provide only a limited view of the complex biological processes occurring during therapy. The study includes patients with epithelial ovarian cancer and primary peritoneal Müllerian tumors who underwent surgery and/or platinum-based chemotherapy. Plasma samples were collected at three predefined treatment timepoints: before surgery (T1), after surgery (T2), and after completion of chemotherapy (T3). A panel of 92 circulating proteins was quantified using Olink proximity extension assay technology. Longitudinal proteomic changes were evaluated in relation to established clinical biomarkers (CA125 and HE4), exploratory proliferation-associated biomarker thymidine kinase 1 (TK1), and KELIM-defined chemosensitivity. The primary objective is to characterize treatment-associated remodeling of the circulating proteome and determine whether these molecular changes reflect tumor burden reduction, treatment exposure, or chemotherapy sensitivity. Secondary objectives include identification of proteins and biological pathways associated with treatment timepoints and assessment of concordance between proteomic changes and established clinical biomarkers. This study aims to improve understanding of dynamic tumor-host interactions during ovarian cancer treatment and to explore the potential role of longitudinal proteomic profiling as a complement to conventional biomarker monitoring.

Official title: Treatment-Associated Longitudinal Plasma Proteomic Remodeling in Ovarian Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2021-10-23

Completion Date

2025-03-10

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

OTHER

Longitudinal Plasma Biomarker Assessment

Serial plasma sampling and proteomic profiling using Olink proximity extension assay technology performed at predefined treatment timepoints (pre-operative, post-operative, and post-chemotherapy). Clinical biomarkers including CA125, HE4, thymidine kinase 1 (TK1), and KELIM-defined chemosensitivity were analyzed in relation to longitudinal proteomic changes.

Locations (1)

UMC Ljubljana

Ljubljana, Slovenia