Back to resultsAutomated Method for Breast Cancer Detection
Primary Purpose
Breast Cancer Diagnosis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fine needle aspiration
Cancer Detection cartridge
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer Diagnosis focused on measuring Breast Cancer Diagnosis, Ultrasound-guided core needle biopsy, Fine needle aspiration, FNA, Diagnostic Cartridge
Eligibility Criteria
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).
Sites / Locations
- Johns Hopkins Hospital Outpatient Center
- Johns Hopkins Medical Imaging at Green spring Station
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Fine Needle Aspiration
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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)
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
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
Full Information
NCT ID
NCT03863522
First Posted
March 4, 2019
Last Updated
October 20, 2021
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1. Study Identification
Unique Protocol Identification Number
NCT03863522
Brief Title
Automated Method for Breast Cancer Detection
Official Title
Automated Method for Breast Cancer Detection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Inadequate FNA samples (low cell counts)
Study Start Date
March 7, 2019 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Diagnosis
Keywords
Breast Cancer Diagnosis, Ultrasound-guided core needle biopsy, Fine needle aspiration, FNA, Diagnostic Cartridge
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fine Needle Aspiration
Arm Type
Other
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Fine needle aspiration
Other Intervention Name(s)
FNA
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Cancer Detection cartridge
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
up to 2 years
Title
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)
Description
Number of participants in whom DNA methylation profile of 10 genes as determined in the Cancer Detection cartridge correlates with FNA cytology
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Correlation of Diagnostic Cartridge With Known Lab Assay
Description
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)
Time Frame
up to 2 years
Title
Correlation of Known Lab Assay for FNA Versus the Core Biopsy
Description
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
Time Frame
up to 2 years
Title
Correlation of Cartridge Based Quantitative Evaluation of Tumor Markers (ER/PR/Her2 and Ki67) in FNA Versus FFPE Sections
Description
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
Time Frame
up to 2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Mullen, MD
Organizational Affiliation
JHU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Johns Hopkins Medical Imaging at Green spring Station
City
Lutherville-Timonium
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Automated Method for Breast Cancer Detection
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