Automated Method for Breast Cancer Detection

Study Overview
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Brief Summary
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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.

Official Title
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Automated Method for Breast Cancer Detection

Conditions
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Breast Cancer Diagnosis

Intervention / Treatment
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* Procedure: Fine needle aspiration
* Device: Cancer Detection cartridge


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fine Needle Aspiration<br>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). | Procedure: Fine needle aspiration<br>* 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.<br>* Other names: FNA;Device: Cancer Detection cartridge<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer Diagnosis, Ultrasound-guided core needle biopsy, Fine needle aspiration, FNA, Diagnostic Cartridge