Tumor suppressor gene methylation is an early step-wise change in benign breast epithelium undergoing neoplastic transformation. Preliminary studies suggest that quantification of DNA methylation in benign random perareolar fine needle aspiration (RP-FNA) samples may provide a marker of breast cancer risk. We assessed the technical performance characteristics of QM- MSP in RP-FNA using an 11-marker panel and performed a case control study that included 31 breast cancer patients and 130 community-based controls. Though DNA methylation does provide a modest risk signal, high inter-assay variability and poor reproducibility make it unattractive for clinical risk stratification in its current form.
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