Accuracy of FNA Versus CNB of Abnormal Axillary Lymph Nodes in Setting of Invasive Breast Cancer
NCT ID: NCT02019303
Last Updated: 2022-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2014-02-28
2019-04-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
Study Groups
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Abnormal lymph nodes
There is only one arm to this study and includes all eligible and consented patients with abnormal axillary lymph node on ultrasound.
FNA and Core biopsy
Both procedures will be performed on the same lymph node
Interventions
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FNA and Core biopsy
Both procedures will be performed on the same lymph node
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
Exclusion Criteria
* Patient is unlikely to undergo lymph node excision (i.e. elderly patient with co-morbidities)
18 Years
ALL
No
Sponsors
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Huntsman Cancer Institute
OTHER
University of Utah
OTHER
Responsible Party
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Nicole Winkler
M.D.
Locations
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Huntsman Cancer Hospital
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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00068472
Identifier Type: -
Identifier Source: org_study_id
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