NCT03863522

Automated Method for Breast Cancer Detection

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Diagnosis

Interventions

Type	Name	Description
PROCEDURE	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.
DEVICE	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.

Timeline

• Start date: 2019-03-07
• Primary completion: 2020-12-15
• Completion: 2020-12-15
• First posted: 2019-03-05
• Last updated: 2021-11-19
• Results posted: 2021-11-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study