Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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 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.

Fine needle aspiration

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.

Cancer Detection cartridge

Lisa Mullen, MD

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.

Automated Method for Breast Cancer Detection

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.

Number of participants in whom DNA methylation profile of 10 genes as determined in the Cancer Detection cartridge correlates with FNA cytology

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)

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

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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

The only intervention is FNA, which is immediately preceded by a core needle biopsy. Thus the cause, FNA vs core biopsy, of the AE will be impossible to determine. Via phone 1-2 days post-procedure and again 10-14 days post-procedure, patients were asked about any bruising and pain, but could report other symptoms if any. Please note only the 62 Johns Hopkins patients were called; the remaining 54 South African patients were not followed for AEs by this study team.

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: 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.

Cancer Detection cartridge: 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.

Fine Needle Aspiration

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

South Africa

Region of Enrollment

Enrollment was halted early due to the quality of samples obtained. Samples contained insufficient cells and could not be analysed.

Dr. Sara Sukumar

Inadequate cell counts prevented analysis of samples. Data was not generated.

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

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Automated Method for Breast Cancer Detection	NCT03863522	Breast Cancer D...	Fine needle asp... Cancer Detectio...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Automated Method for Breast Cancer Detection	NCT03863522	Breast Cancer D...	Fine needle asp... Cancer Detectio...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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