Study to Improve Diagnosis of Borderline and Stage I Invasive Ovarian Cancer Using Biomarkers

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.

A Prospective Multicenter Diagnostic Biomarker Study to Discriminate Borderline From Stage I Invasive Ovarian Cancer