Clinical Trial

Gene Methylation for Diagnosis of Breast Lesions

Completed
View on ClinicalTrials.gov →
Summary
Breast lesions of uncertain malignant potential represent a diagnostic challenge, as conventional histopathological assessment does not always reliably distinguish between benign and malignant changes. The purpose of this prospective diagnostic study is to evaluate whether methylation patterns of selected breast cancer-related genes (BRCA1, RASSF1A, and PTEN) can help differentiate benign from malignant breast lesions. Tissue samples obtained during diagnostic needle biopsy, and when applicable during surgical excision, will be analyzed for gene methylation status. The results will be compared with standard histopathological findings. The study aims to improve diagnostic accuracy in breast lesions of uncertain malignant potential and contribute to better clinical decision-making in breast diagnostics.
Trial Details
NCT Number NCT07428733
Lead Sponsor Institute of Oncology Ljubljana
Conditions Breast Lesions of Uncertain Malignant Potential, PTEN
Enrollment 401 participants
Start Date 2024-09-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-01-09 (estimated)
Updated on ClinicalTrials.gov 2026-02-24