NCT06709872Recruiting
A Prospective Multicenter Diagnostic Biomarker Study to Discriminate Borderline From Stage I Invasive Ovarian Cancer
Discriminating Borderline From Stage I Invasive Ovarian Cancer (BIOC): a Prospective Multicenter Diagnostic Biomarker Study
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 26 Nov 2024
- Start date
- 3 Jun 2025
- Primary completion date
- 3 Sept 2029
- Lead sponsor
- KU Leuven
- Diseases
- Ovarian cancer
- NCT number
- NCT06709872
What you commit to
- Study type: Observational
- Planned participants: 400
- From 3 Jun 2025 to the primary completion date, 3 Sept 2029
- 4 sites in 3 countries
- 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.
Age
- Participants eligible for this Study must not meet any of the following criteria:
- Participants younger than 18 years old,
- 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
- Participants who refuse the preoperative transvaginal ultrasonography and/or blood sample
- Participants with known simultaneous and/or previous malignancies within five years prior to BIOC participation
- Participants with infectious serology (i.e. HIV, Hepatitis B, Hepatitis C)
- Participants who deny or withdraw the written informed consent
Who the study is looking for
- Participants eligible for inclusion in this study must meet all of the following criteria:
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- Ultrasound discovery of a cyst on the ovary, suspicious for BOT or stage I invasive tumor (subjective assessment)
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| General Faculty Hospital of the Charles University Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Istituto Nazionale dei Tumore Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Università Cattolica del Sacro Cuore Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.