Biomarker panel to tell BOT from stage I ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational study aiming to improve preoperative discrimination between borderline ovarian tumors and stage I invasive ovarian cancer. Building on prior work, it expands a biomarker panel to nine proteins, including CA125, HE4, CA72.4, and CCL11, to identify a signature that works with or without ultrasound data. The goal is to guide surgical planning and treatment decisions and to create a robust BOT versus stage I cancer database across Europe. Participants are adults with ultrasound-detected ovarian cysts suspicious for BOT or stage I cancer, undergoing preoperative assessment and blood sampling. The study does not specify an intervention beyond biomarker testing and data collection.

Why it matters

Who can join: the full rules

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

Where it's running

• UZ Leuven
  Leuven, Flemish Brabant, Belgium Recruiting
• General Faculty Hospital of the Charles University
  Prague, Czechia Recruiting
• Istituto Nazionale dei Tumore
  Milan, Italy Not yet recruiting
• Università Cattolica del Sacro Cuore
  Rome, Italy Not yet recruiting

Study contacts

• Principal investigator: An Coosemans — KU Leuven
• Study coordinator: An Coosemans
• Email: an.coosemans@kuleuven.be
• Phone: +32 16 37 77 88

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.