A Prospective Multicenter Diagnostic Biomarker Study to Discriminate Borderline From Stage I Invasive Ovarian Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorKU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Patients with ultrasound discovery of a cyst on the ovary, suspicious for BOT or stage I invasive tumor
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 2 trial groupsGroup A: Borderline ovarian tumor cohort
Group B: stage I invasive ovarian cancer cohort
Trial outcomes
Primary outcomes
1
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).
Time frame
After 12 months following the recruitmentSecondary outcomes
1
Database establishment
Establishment of a database for borderline ovarian tumors (BOT) and stage I invasive ovarian cancer to address future research questions.
Time frame
Start registering the data of patients in the database from the day of recruitment Source ClinicalTrials.gov