Stage I Ovarian CancerBIOCNCT06709872
A Prospective Multicenter Diagnostic Biomarker Study to Discriminate Borderline From Stage I Invasive Ovarian Cancer
An observational study of Stage I Ovarian Cancer and Borderline Ovarian Tumors, run by KU Leuven at 4 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage I Ovarian Cancer, Borderline Ovarian Tumors
- How many people
- 400 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 3 Jun 2025to 3 Sep 2029
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with ultrasound discovery of a cyst on the ovary, suspicious for BOT or stage I invasive tumor
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Italy2 sites, 2 recruiting
- Not yet recruiting
Istituto Nazionale dei Tumore
Milan
Valentina Chiappa, +390223903470, Valentina.chiappa@associazionetumori.mi.it
Valentina Chiappa, MD
- Not yet recruiting
Università Cattolica del Sacro Cuore
Rome
Antonia Carla Testa, +39 06 30158192, antoniacarla.testa@policlinicogemelli.it
Antonia Carla Testa, MD, PhD
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Flemish Brabant, 3000
Kainat Jamil, +3216343957, kainat.jamil@kuleuven.be
An Coosemans, MD, PhD
Czechia1 site, 1 recruiting
- Recruiting
General Faculty Hospital of the Charles University
Prague
Tereza Poľanová, +420 224 967 432, tereza.polanova@vfn.cz
Daniela Fischerová, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Stage I Ovarian Cancer, Borderline Ovarian Tumors
- Keywords
- Borderline ovarian tumors, stage I ovarian cancer, diagnostic, biomarkers
- Medical subject headings
- Ovarian Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of biomarkers
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).
Measured: After 12 months following the recruitment
Secondary outcomes (1)
Database establishment
Establishment of a database for borderline ovarian tumors (BOT) and stage I invasive ovarian cancer to address future research questions.
Measured: Start registering the data of patients in the database from the day of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start3 Jun 2025
- Primary completion3 Sep 2029 (estimated)
- Study completion3 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Ovarian CancerStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, An Coosemans, KU Leuven
- Investigators
- An Coosemans, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709872
- Sponsor's protocol ID
- S69849
- Other IDs
- 13583
- Acronym
- BIOC
- Status last verified
- Mar 2026
- First submitted
- 26 Nov 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discriminating Borderline From Stage I Invasive Ovarian Cancer (BIOC): a Prospective Multicenter Diagnostic Biomarker Study
- ClinicalTrials.gov ID
- NCT06709872
- Acronym / sponsor ID
- BIOC / S69849
- Conditions
- Stage I Ovarian Cancer, Borderline Ovarian Tumors
- Keywords
- Borderline ovarian tumors, stage I ovarian cancer, diagnostic, biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 3 Sep 2029 (estimated)
- Study completion
- 3 Sep 2029 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ultrasound discovery of a cyst on the ovary, suspicious for BOT or stage I invasive tumor
Key inclusion criteria (4 listed)
- Participants eligible for inclusion in this study must meet all of the following criteria:
Key exclusion criteria (7 listed)
- Participants eligible for this Study must not meet any of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Database establishment
Time frame: Start registering the data of patients in the database from the day of recruitment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
An Coosemans principal investigator
KU Leuven
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage I Ovarian Cancer and Borderline Ovarian Tumors, run by KU Leuven at 4 sites in 3 countries.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Belgium, Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact An Coosemans (+32 16 37 77 88, an.coosemans@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of biomarkers (time frame: After 12 months following the recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026; AzTrials last refreshed its copy on 2 Nov 2026.