Accuracy of FNA Versus CNB of Abnormal Axillary Lymph Nodes in Setting of Invasive Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FNA and Core biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Recent or suspected diagnosis of invasive breast cancer with abnormal ipsilateral axillary lymph node
- Able to provide informed consent
Exclusion Criteria:
- Lymph node not amenable to core biopsy
- Patient is unlikely to undergo lymph node excision (i.e. elderly patient with co-morbidities)
Sites / Locations
- Huntsman Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Abnormal lymph nodes
Arm Description
There is only one arm to this study and includes all eligible and consented patients with abnormal axillary lymph node on ultrasound.
Outcomes
Primary Outcome Measures
Accuracy of FNA and CNB
Accuracy will be determined by comparing the results of the FNA and CNB performed on the same lymph node to the gold standard using a paired test of equivalence. The gold standard is the final pathologic diagnosis of excised lymph node containing biopsy marker (either sentinel lymph node biopsy or axillary dissection). Surgical excision of pre-operatively sampled lymph node marks the end of study participation for each patient.
Secondary Outcome Measures
Pain associated with FNA and CNB
Pain associated with each biopsy method will be assessed with a visual analog scale (0- 10) after a baseline pain measurement. The results will be compared to baseline pain level and analyzed using a paired t test.
Full Information
NCT ID
NCT02019303
First Posted
December 3, 2013
Last Updated
October 31, 2022
Sponsor
University of Utah
Collaborators
Huntsman Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT02019303
Brief Title
Accuracy of FNA Versus CNB of Abnormal Axillary Lymph Nodes in Setting of Invasive Breast Cancer
Official Title
Ultrasound Guided Core Needle Biopsy Versus Fine Needle Aspiration of Morphologically Abnormal Axillary Lymph Node in Patients With New Diagnosis or Suspected Diagnosis of Invasive Breast Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Huntsman Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare accuracy of ultrasound guided fine needle aspiration (FNA) to core needle biopsy (CNB) of ultrasound detected abnormal axillary lymph nodes in patients with newly diagnosed invasive breast cancer or suspected invasive breast cancer.
Hypothesis: FNA and CNB have equivalent diagnostic accuracies
In order to prove our hypothesis, we will perform FNA and CNB on the same lymph node in each consented patient. The two samples will be evaluated separately by different pathologists blinded to the material in the other sample.
The results of the biopsies will be compared to the gold standard (lymph node excision).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abnormal lymph nodes
Arm Type
Other
Arm Description
There is only one arm to this study and includes all eligible and consented patients with abnormal axillary lymph node on ultrasound.
Intervention Type
Procedure
Intervention Name(s)
FNA and Core biopsy
Intervention Description
Both procedures will be performed on the same lymph node
Primary Outcome Measure Information:
Title
Accuracy of FNA and CNB
Description
Accuracy will be determined by comparing the results of the FNA and CNB performed on the same lymph node to the gold standard using a paired test of equivalence. The gold standard is the final pathologic diagnosis of excised lymph node containing biopsy marker (either sentinel lymph node biopsy or axillary dissection). Surgical excision of pre-operatively sampled lymph node marks the end of study participation for each patient.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Pain associated with FNA and CNB
Description
Pain associated with each biopsy method will be assessed with a visual analog scale (0- 10) after a baseline pain measurement. The results will be compared to baseline pain level and analyzed using a paired t test.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recent or suspected diagnosis of invasive breast cancer with abnormal ipsilateral axillary lymph node
Able to provide informed consent
Exclusion Criteria:
Lymph node not amenable to core biopsy
Patient is unlikely to undergo lymph node excision (i.e. elderly patient with co-morbidities)
Facility Information:
Facility Name
Huntsman Cancer Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Accuracy of FNA Versus CNB of Abnormal Axillary Lymph Nodes in Setting of Invasive Breast Cancer
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