Participants with suspicious breast lesions by mammography will undergo fine needle aspiration (FNA) under ultrasound guidance. The FNA will be read by the cytopathologist and analyzed in the breast cancer detection cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis). We will also receive FNA collected from 60 patients with palpable lesions in South Africa and analyze them samples in our lab with the same method.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
116
Fine needle aspiration is a type of biopsy procedure to diagnose suspicious lesions. After giving numbing medicine, a thin needle is inserted into the breast to obtain a sample. This procedure is followed by the standard of care and will last about 10 minutes. The sample will be analyzed by a diagnostic cartridge and by the cytopathologist.
The Cancer Detection cartridge has the ability to measure methylated gene changes in breast cells. The device will not be in contact with the patients. The FNA samples will be smeared on a slide which will be placed into the cartridge for analysis.
Johns Hopkins Hospital Outpatient Center
Baltimore, Maryland, United States
Johns Hopkins Medical Imaging at Green spring Station
Lutherville-Timonium, Maryland, United States
Correlation of Diagnostic Cartridge With Histopathology as Assessed by Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Core Biopsy or Resected Lesion
Number of participants in whom DNA methylation profile of 10 genes in the Cancer Detection cartridge correlates with diagnosis based on the gold standard of histopathology of the core biopsy or resected sample.
Time frame: up to 2 years
Correlation of Diagnostic Cartridge With Cytopathology as Assessed by Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Cytology of Fine Needle Aspiration (FNA)
Number of participants in whom DNA methylation profile of 10 genes as determined in the Cancer Detection cartridge correlates with FNA cytology
Time frame: up to 2 years
Correlation of Diagnostic Cartridge With Known Lab Assay
Number of participants in whom gene-methylation prediction of FNA in the Cancer Detection cartridge is malignant or benign when compared to gene-methylation prediction of FNA using our known laboratory assay (QM-MSP)
Time frame: up to 2 years
Correlation of Known Lab Assay for FNA Versus the Core Biopsy
Number of participants in whom gene-methylation prediction of benign or malignant using our known laboratory assay (QM-MSP) matches for both the FNA sample and the core biopsy sample
Time frame: up to 2 years
Correlation of Cartridge Based Quantitative Evaluation of Tumor Markers (ER/PR/Her2 and Ki67) in FNA Versus FFPE Sections
Number of participants with same expression of ER/PR/Her2 and Ki67 in FNAs of methylation positive breast lesions as with expression of ER/PR/Her2 and Ki67 in Formalin-Fixed Paraffin-Embedded (FFPE) sections of tumors using cartridge based quantitative evaluation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 2 years