Clinical Trial

Longitudinal Plasma Proteomic Remodeling in Ovarian Cancer

Study acronym: TLPPROC
Completed
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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.
Trial Details
NCT Number NCT07684846
Lead Sponsor University Medical Centre Ljubljana
Collaborators: Helmholtz Zentrum München
Conditions Ovarian Cancer, Ovarian Cancer Recurrent
Enrollment 33 participants
Start Date 2021-10-23
Primary Completion 2025-01-07 (estimated)
Study Completion 2025-03-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-06