Automated Method for Breast Cancer Detection

Not Applicable

Terminated

Interventions: Procedure: Fine needle aspiration
Device: Cancer Detection cartridge

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Patient must be female
Patient must be 18 years of age or older
Patient has been recommended for ultrasound core needle biopsy of a suspicious breast lesion

Exclusion Criteria

Patients may be excluded for any condition that in the opinion of the investigator may not make it safe to take part (e.g. certain medicines).

Arm && Interventions

Group	Intervention	Description
Fine Needle Aspiration	Fine needle aspiration	Participants will receive fine needle aspiration (FNA) later read by the cytopathologist and the cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis).
Fine Needle Aspiration	Cancer Detection cartridge	Participants will receive fine needle aspiration (FNA) later read by the cytopathologist and the cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis).

Primary Outcome Measures

Name	Time	Method
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	up to 2 years	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.
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)	up to 2 years	Number of participants in whom DNA methylation profile of 10 genes as determined in the Cancer Detection cartridge correlates with FNA cytology

Secondary Outcome Measures

Name	Time	Method
Correlation of Diagnostic Cartridge With Known Lab Assay	up to 2 years	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)
Correlation of Cartridge Based Quantitative Evaluation of Tumor Markers (ER/PR/Her2 and Ki67) in FNA Versus FFPE Sections	up to 2 years	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
Correlation of Known Lab Assay for FNA Versus the Core Biopsy	up to 2 years	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

Locations (2): Johns Hopkins Hospital Outpatient Center
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Baltimore, Maryland, United States
Johns Hopkins Medical Imaging at Green spring Station
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Lutherville-Timonium, Maryland, United States