Evaluation of a New DNA Test on Bloody Nipple Fluid to Distinguish Benign and Malignant Breast Conditions Before Surgery

What this Trial Is About

Researchers are evaluating a new, less invasive laboratory test to analyze DNA from nipple fluid in adults with spontaneous, single-duct, unilateral bloody or blood-tinged nipple discharge. The goal is to distinguish between benign and malignant causes of the discharge and potentially reduce unnecessary surgeries. This observational study enrolls about 30 participants who are already scheduled for standard diagnostic breast surgery at a single center. Before surgery, a small sample of nipple fluid or nipple aspirate fluid is collected along with a blood sample. The DNA in the fluid is analyzed using low-pass whole-genome sequencing and genome-wide DNA methylation profiling. These data are compared to surgical pathology results to develop a model that classifies lesions as benign or malignant. Participants receive usual care, and study results do not affect their treatment. There is no long-term follow-up required. During the study, participants undergo sample collection before surgery and standard surgical procedures. Researchers review surgical pathology reports to assess the tests accuracy, including sensitivity, specificity, and predictive values. Safety monitoring includes minimizing discomfort from fluid collection and blood draws. The total participation time covers preoperative sampling through receipt of final pathology, with technical success and sample adequacy also assessed.

A Study on Combined Low-pass Whole-genome and Methylome Testing of Bloody Nipple Discharge Specimens for Benign-Malignant Differentiation.