NCT07684846Completed
Longitudinal Plasma Proteomic Remodeling in Ovarian Cancer
Treatment-Associated Longitudinal Plasma Proteomic Remodeling in Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 33 (actual)
- First submitted
- 1 Jun 2026
- Start date
- 28 Sept 2018
- Primary completion date
- 9 Mar 2021
- Lead sponsor
- University Medical Centre Ljubljana
- Diseases
- Ovarian cancer
- NCT number
- NCT07684846
What you commit to
- Study type: Observational
- Participants enrolled: 33
- From 28 Sept 2018 to the primary completion date, 9 Mar 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another study that would prevent interpretation of biomarker analyses.
Other illness
- Non-epithelial ovarian malignancies.
Other
- Insufficient plasma sample volume or inadequate sample quality for proteomic analysis.
- Missing essential clinical data required for study analyses.
- Withdrawal of informed consent.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UMC Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.