Using CfDNA Methylation to Help Diagnose Breast Cancer Distinguishing Between Benign and Malignant Breast Nodules

What this Trial Is About

Researchers are developing a diagnostic model to help distinguish breast cancer from benign breast diseases by studying methylation markers in blood and tissue samples. This observational study focuses on collecting samples from participants diagnosed with either breast cancer or benign breast conditions to analyze whole-genome methylation patterns. The goal is to find specific methylation markers that can assist in diagnosing breast nodules more accurately. The study involves two groups one with participants having breast cancer and another with participants having benign breast diseases. Blood and tumor tissue samples will be collected from the cancer group, while blood and tissue samples will be collected from the benign group. These samples will undergo whole-genome methylation sequencing to identify diagnostic markers and develop a model that can differentiate malignant from benign breast nodules. Participants will provide tissue and blood samples, and their molecular subtyping results will be confirmed. Researchers will examine DNA methylation profiles over 12 months, evaluating the performance of methylation markers and integrating them with imaging results. The study aims to create a combined diagnostic model with high specificity and sensitivity. The total study duration for each participant is 12 months, during which safety and study completion will be monitored.

Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer