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Longitudinal Plasma Proteomic Remodeling in Ovarian Cancer

NCT07684846 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-07-06

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Helmholtz Zentrum München

    collaborator INDUSTRY

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Joško Osredkar, Prof, PhD · Institute of Clinical Chemistry and Biochemistry, Ljubljana University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-23
Primary Completion
2025-01-07
Completion
2025-03-10

Countries

  • Slovenia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07684846 on ClinicalTrials.gov