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NCT02019303 · ClinicalTrials.gov registry record · NA
Accuracy of FNA Versus CNB of Abnormal Axillary Lymph Nodes in Setting of Invasive Breast Cancer
A NA study, sponsored by University of Utah.
- Completed
- Registry status
- NA
- Development phase
- 140
- Enrollment target
NCT02019303: Completed NA study, sponsored by University of Utah.
NCT02019303 is a NA study that has completed, run by University of Utah. The registered enrollment target is 140 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02019303, a NA study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
Study 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).
Primary Outcome
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.
Interventions
- PROCEDURE FNA and Core biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2014-02 |
| Est. Completion | 2019-04-30 |
| Phase | NA |
What the finished NCT02019303 record still lists
NCT02019303 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which FNA and Core biopsy is the first listed.
NCT02019303 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02019303 about?
NCT02019303 is a clinical study titled "Accuracy of FNA Versus CNB of Abnormal Axillary Lymph Nodes in Setting of Invasive Breast Cancer". 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 accu...
What is the current status of trial NCT02019303?
This trial is currently completed. It is a NA study. The enrollment target is 140 participants. The study started on 2014-02. Estimated completion is 2019-04-30.
What interventions are being tested in trial NCT02019303?
The interventions under investigation include: FNA and Core biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT02019303?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02019303's enrollment target sits among peer trials
140 713th of 2000 higher than 1,281 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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