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Ovarian CancerTLPPROCNCT07684846

Longitudinal Plasma Proteomic Remodeling in Ovarian Cancer

An observational study of Ovarian Cancer and Ovarian Cancer Recurrent, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer, Ovarian Cancer Recurrent
What is being tested?
Longitudinal Plasma Biomarker Assessment
How many people
33 participants
Where
1 siteSlovenia
Study dates
28 Sep 2018to 10 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: This longitudinal observational study included 33 patients with histologically documented epithelial ovarian or primary peritoneal Müllerian tumors treated at University Medical Centre Ljubljana, Slovenia. Median age was 60.3 years, and 26 patients (78.8%) had FIGO stage III-IV disease. Histological subtypes included high-grade serous (n=21), low-grade serous (n=4), endometrioid (n=5), clear-cell (n=1), and serous borderline tumors (n=2). Twenty patients underwent primary surgery, while 13 received neoadjuvant chemotherapy followed by interval surgery. A total of 84 serum samples were collected at three treatment-related timepoints: preoperative (T1, n=31), postoperative (T2, n=26), and post-chemotherapy (T3, n=27). All participants provided written informed consent.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

  • UMC Ljubljana

    Ljubljana

Other trials in Slovenia

About this study

Official title: Treatment-Associated 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.

Read more

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.

Being tested
Longitudinal Plasma Biomarker Assessment
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Longitudinal Plasma Biomarker AssessmentOther

    Serial serum 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.

Study groups in NCT07684846
Study groupRoleWhat they receive
Standard-of-Care Ovarian Cancer TreatmentPatients with epithelial ovarian cancer or primary peritoneal Müllerian tumors undergoing standard clinical management, including primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery, platinum-based chemotherapy, and maintenance therapy when clinically indicated. Serial serum samples were collected for longitudinal proteomic analysis.
Receives: Other: Longitudinal Plasma Biomarker Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in serum protein levels

    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. Olink Target 96 Oncology II, NPX.

    Measured: Change between T1, T2 and T3. 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).

Secondary outcomes (1)

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

    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).

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2026
  2. Study start28 Sep 2018
  3. Primary completion9 Mar 2021
  4. Study completion10 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07684846
Sponsor's protocol ID
KOG UMC LJUBLJANA
Other IDs
20240125
Acronym
TLPPROC
Status last verified
May 2026
First submitted
1 Jun 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data that support the findings of the study are available from the corresponding author upon reasonable request.

Publications

  • [1] Konstantinopoulos PA, Matulonis UA. Clinical and translational advances in ovarian cancer therapy. Nat Cancer. 2023 Sep;4(9):1239-1257. doi: 10.1038/s43018-023-00617-9. [2] Whitwell HJ, Worthington J, Blyuss O, Gentry-Maharaj A, Ryan A, Gunu R et al. Improved early detection of ovarian cancer using longitudinal multimarker models. Br J Cancer. 2020 Mar;122(6):847-856. doi: 10.1038/s41416-019-0718-9. [3] Charkhchi P, Cybulski C, Gronwald J, Wong FO, Narod SA, Akbari MR. CA125 and Ovarian Cancer: A Comprehensive Review. Cancers (Basel). 2020 Dec 11;12(12):3730. doi: 10.3390/cancers12123730. [4] Alegría-Baños JA, Jiménez-López JC, Vergara-Castañeda A, de León DFC, Mohar-Betancourt A, Pérez-Montiel D et al. Kinetics of HE4 and CA125 as prognosis biomarkers during neoadjuvant chemotherapy in advanced epithelial ovarian cancer. J Ovarian Res. 2021 Jul 19;14(1):96. doi: 10.1186/s13048-021-00845-6. [5] You B, Colomban O, Heywood M, Lee C, Davy M, Reed N et al. The strong prognostic value of KELIM, a model-based parameter from CA 125 kinetics in ovarian cancer: data from CALYPSO trial (a GINECO-GCIG study). Gynecol Oncol. 2013 Aug;130(2):289-94. doi: 10.1016/j.ygyno.2013.05.013. [6] Lauby A, Colomban O, Corbaux P, Peron J, Van Wagensveld L, Gertych W et al. The Increasing Prognostic and Predictive Roles of the Tumor Primary Chemosensitivity Assessed by CA-125 Elimination Rate Constant K (KELIM) in Ovarian Cancer: A Narrative Review. Cancers (Basel). 2021 Dec 25;14(1):98. doi: 10.3390/cancers14010098. [7] Bradbury M, Borràs E, Pérez-Benavente A, Gil-Moreno A, Santamaria A, Sabidó E. Proteomic Studies on the Management of High-Grade Serous Ovarian Cancer Patients: A Mini-Review. Cancers (Basel). 2021 Apr 25;13(9):2067. doi: 10.3390/cancers13092067. [8] Qian L, Zhu J, Xue Z, et al. Proteomic landscape of epithelial ovarian cancer. Nat Commun. 2024;15(1):6462. doi: 10.1038/s41467-024-50786-z. [9] Li Y, Wang B, Yang W, Ma F, Zou J, Li K, Tan S, Feng J, Wang Y, Qin Z,

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Cancer and Ovarian Cancer Recurrent, run by University Medical Centre Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum protein levels (time frame: Change between T1, T2 and T3. 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07684846, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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