Automated Method for Breast Cancer Detection

Breast Cancer Diagnosis Clinical Trial

Official title:

Automated Method for Breast Cancer Detection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03863522
• Other study ID #: J18138
• Secondary ID: IRB00172441
• Status: Terminated
• Phase: N/A
• Start date: March 7, 2019
• Est. completion date: December 15, 2020

Study information

• Verified date: October 2021
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 116
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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).

Related Conditions & MeSH terms

• Breast Cancer Diagnosis
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital Outpatient Center	Baltimore	Maryland
United States	Johns Hopkins Medical Imaging at Green spring Station	Lutherville-Timonium	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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