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NCT Number: NCT07684846

Longitudinal Plasma Proteomic Remodeling in Ovarian Cancer

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Recurrent Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UMC Ljubljana

Ljubljana, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years.
  • Histologically confirmed epithelial ovarian cancer or primary peritoneal Müllerian carcinoma.
  • Undergoing standard treatment including surgery and/or systemic therapy.
  • Availability of plasma samples collected at one or more predefined treatment timepoints (pre-operative, post-operative, and/or post-chemotherapy).
  • Availability of corresponding clinical and biomarker data (CA125 and/or HE4).
  • Written informed consent

Exclusion criteria

  • Non-epithelial ovarian malignancies.
  • Insufficient plasma sample volume or inadequate sample quality for proteomic analysis.
  • Missing essential clinical data required for study analyses.
  • Withdrawal of informed consent.
  • Concurrent participation in another study that would prevent interpretation of biomarker analyses.

Treatment and study plan

Longitudinal Plasma Biomarker Assessment

Other

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.

Primary outcomes

  1. Treatment-associated changes in circulating plasma protein levels

    Time frame: Time 1 (Baseline, prior to primary cytoreductive surgery); Time 2 (1 month after primary cytoreductive surgery); Time 3 (after completion of first-line chemotherapy, up to 12 months after treatment initiation).

    Identification of circulating proteins significantly associated with treatment timepoint (pre-operative, post-operative, and post-chemotherapy) as measured by Olink normalized protein expression (NPX) values and analyzed using longitudinal mixed-effects models.

Secondary outcomes

  1. Changes in serum CA125 and HE4 concentrations across treatment timepoints and their association with longitudinal proteomic remodeling.

    Time frame: Time 1 (Baseline, prior to surgery); Time 2 (1 month after primary cytoreductive surgery); Time 3 (after completion of first-line chemotherapy, up to 12 months after treatment initiation).

    Correlation between changes in plasma protein levels and changes in CA125 and HE4 concentrations between baseline (Time 1) and post-treatment measurements (Time 2 and Time 3).

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • Helmholtz Zentrum München

Registry information

Official study title

Treatment-Associated Longitudinal Plasma Proteomic Remodeling in Ovarian Cancer

Acronym: TLPPROC

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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