A Prospective Multicenter Diagnostic Biomarker Study to Discriminate Borderline From Stage I Invasive Ovarian Cancer (BIOC)

May 19, 2026 updated by: An Coosemans, KU Leuven

Discriminating Borderline From Stage I Invasive Ovarian Cancer (BIOC): a Prospective Multicenter Diagnostic Biomarker Study

The study aims to improve the diagnosis of ovarian cancer by distinguishing between borderline ovarian tumors (BOT) and stage I invasive ovarian cancer. Other than the traditional diagnostic biomarker CA125, the previous study TRANS-IOTA (translational-international ovarian tumor analysis; S51375/S59207), conducted by similar investigators, pointed at biomarkers like HE4, CA72.4, CA15.3, and CCL11, as potential markers to discriminate BOT from stage I cancer. BIOC is the follow-up study, which will include four additional promising biomarkers to expand the panel to nine. The investigators aim to confirm whether a subpanel of these nine biomarkers has diagnostic value. Such a biomarker signature would enhance the accuracy of distinguishing between BOT and stage I invasive ovarian cancer before surgery, leading to more precise treatment and improved patient outcomes.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The BIOC study, titled Discriminating Borderline from Stage I Invasive Ovarian Cancer, is a prospective, multicenter diagnostic biomarker study designed to refine diagnostic accuracy for ovarian cancer, specifically to differentiate between borderline ovarian tumors (BOT) and stage I invasive ovarian cancer. Existing diagnostic tools, such as the CA125 biomarker, are limited in their ability to provide precise differentiation in early stages, which is crucial for appropriate pre-surgical treatment planning. This study builds upon findings from the TRANS-IOTA (translational-international ovarian tumor analysis) study, expanding the biomarker panel to nine proteins, including CA125, HE4, CA72.4, and CCL11, alongside four additional biomarkers selected through systematic literature review.

The primary objective of BIOC is to develop a biomarker signature capable of distinguishing BOT from early-stage invasive ovarian cancer. This would allow for more accurate diagnoses either independently or in combination with ultrasound variables, thereby improving pre-surgical decision-making, reducing the need for second surgeries, and supporting more tailored treatments that improve patient outcomes. For younger patients with BOT, for instance, accurate differentiation could allow for fertility-preserving surgical options. A secondary aim of the study is to establish a robust database for BOT and stage I invasive ovarian cancer across Flanders (Belgium) and Europe, capturing detailed clinical, ultrasound, histological, and immune data that will guide future research and support gynecologists in refining their diagnostic approaches.

BIOC will be conducted across multiple hospitals in Flanders (Belgium) and a few European centers and aims to enroll 200 patients with BOT and 200 with stage I invasive ovarian cancer. Participants will primarily be recruited through gynecology ultrasound departments, where they will receive pre-surgical blood sampling and clinical evaluations. Recruitment will occur over three years, with the study concluding after a subsequent two-year analysis period, aiming for completion between 2028 and 2029.

By establishing a validated biomarker panel for early ovarian cancer diagnosis, BIOC has the potential to significantly enhance diagnostic accuracy and efficiency. This could transform the precision of preoperative assessments, reduce unnecessary invasive procedures, and improve overall treatment planning, thus enhancing patient outcomes and quality of life for those affected by ovarian cancer.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
        • Principal Investigator:
          • An Coosemans, MD, PhD
        • Sub-Investigator:
          • Dirk Timmerman, MD, PhD
        • Sub-Investigator:
          • Ben Van Calster, PhD
        • Sub-Investigator:
          • Thaïs Baert, MD, PhD
  • Czechia
      • Prague, Czechia
        • Recruiting
        • General Faculty Hospital of the Charles University
        • Contact:
        • Principal Investigator:
          • Daniela Fischerová, MD, PhD
  • Italy
      • Milan, Italy
      • Rome, Italy
        • Not yet recruiting
        • Universita Cattolica del Sacro Cuore
        • Contact:
        • Principal Investigator:
          • Antonia Carla Testa, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with ultrasound discovery of a cyst on the ovary, suspicious for BOT or stage I invasive tumor

Description

Inclusion Criteria:

  • Participants eligible for inclusion in this study must meet all of the following criteria:

    1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
    2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
    3. Ultrasound discovery of a cyst on the ovary, suspicious for BOT or stage I invasive tumor (subjective assessment)

Exclusion Criteria:

  • Participants eligible for this Study must not meet any of the following criteria:

    1. Participants younger than 18 years old,
    2. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
    3. Participants who refuse the preoperative transvaginal ultrasonography and/or blood sample
    4. Participants with known simultaneous and/or previous malignancies within five years prior to BIOC participation
    5. Participants with infectious serology (i.e. HIV, Hepatitis B, Hepatitis C)
    6. Participants who deny or withdraw the written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Borderline ovarian tumor cohort
Patients with ultrasound discovery of a cyst on the ovary, suspicious for BOT
stage I invasive ovarian cancer cohort
Patients with ultrasound discovery of a cyst on the ovary, suspicious for stage I invasive ovarian cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of biomarkers
Time Frame: After 12 months following the recruitment
Diagnostic performance of a protein-based biomarker or set of biomarkers that can discriminate between BOT and stage I invasive ovarian cancer in terms of area under the receiver operative characteristics curve (AUROC).
After 12 months following the recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Database establishment
Time Frame: Start registering the data of patients in the database from the day of recruitment
Establishment of a database for borderline ovarian tumors (BOT) and stage I invasive ovarian cancer to address future research questions.
Start registering the data of patients in the database from the day of recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Principal Investigator: An Coosemans, KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2025

Primary Completion (Estimated)

September 3, 2029

Study Completion (Estimated)

September 3, 2029

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S69849
  • 13583 (Other Grant/Funding Number: Stand up to Cancer (Kom op tegen Kanker))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Borderline Ovarian Tumors

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe