Actively Recruiting
Discriminating Borderline From Stage I Invasive Ovarian Cancer (BIOC): a Prospective Multicenter Diagnostic Biomarker Study
Led by KU Leuven · Updated on 2026-05-22
400
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating new ways to improve the diagnosis of ovarian cancer, focusing on distinguishing between borderline ovarian tumors (BOT) and stage I invasive ovarian cancer. This diagnostic challenge is important because current tools like the CA125 biomarker do not always accurately differentiate these early stages, which can affect treatment decisions. The study builds on previous research that identified several potential biomarkers and aims to confirm if a group of nine biomarkers can better identify these conditions before surgery. The study will include women with ovarian cysts suspected to be either BOT or stage I invasive cancer, based on ultrasound findings. Blood samples and clinical evaluations will be collected before surgery. The study will be conducted across multiple hospitals in Flanders, Belgium, and other European centers. It plans to enroll 400 participants over three years, with 200 women in each group. Researchers will analyze the diagnostic value of the combined biomarker panel and create a detailed database of clinical and ultrasound information to support future research. Participants will be involved primarily through pre-surgical visits where blood samples and ultrasound assessments occur. Researchers will monitor the diagnostic performance of the biomarkers over 12 months following recruitment. The study also aims to build a comprehensive database capturing clinical, histological, and immune data to help gynecologists refine diagnosis and treatment planning. The study is expected to conclude by 2029, improving early ovarian cancer diagnosis and potentially leading to more personalized and effective care.
CONDITIONS
Brief Title
A Prospective Multicenter Diagnostic Biomarker Study to Discriminate Borderline From Stage I Invasive Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent obtained before screening
- At least 18 years old at the time of consent
- Ultrasound shows a cyst on the ovary suspected to be a borderline ovarian tumor or stage I invasive tumor
You will not qualify if you...
- Younger than 18 years old
- Pregnant, breastfeeding, planning pregnancy, or of child-bearing potential without effective contraception
- Refusal of preoperative transvaginal ultrasound or blood sample
- Known malignancies within five years prior to participation
- Infectious serology positive for HIV, Hepatitis B, or Hepatitis C
- Withdrawal or denial of written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants undergo pre-surgical blood sampling and clinical evaluations, including ultrasound assessment, to collect biomarker and clinical data to help differentiate between borderline ovarian tumors and stage I invasive ovarian cancer.
1 visit (in-person) at recruitment
Duration - Up to 2 years following recruitment
Participants' biomarker data and clinical information are recorded and analyzed to develop and validate diagnostic accuracy over time.
No additional visits required
Trial Site Locations
Total: 4 locations
1
UZ Leuven
Leuven, Flemish Brabant, Belgium, 3000
Actively Recruiting
2
General Faculty Hospital of the Charles University
Prague, Czechia
Actively Recruiting
3
Istituto Nazionale dei Tumore
Milan, Italy
Not Yet Recruiting
4
Università Cattolica del Sacro Cuore
Rome, Italy
Not Yet Recruiting
Research Team
A
An Coosemans
K
Kainat Jamil
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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