Accuracy of FNA Versus CNB of Abnormal Axillary Lymph Nodes in Setting of Invasive Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02019303|
Recruitment Status : Active, not recruiting
First Posted : December 24, 2013
Last Update Posted : January 30, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: FNA and Core biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Actual Study Start Date :||February 2014|
|Actual Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2020|
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.
Procedure: FNA and Core biopsy
Both procedures will be performed on the same lymph node
- Accuracy of FNA and CNB [ Time Frame: 2 years ]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.
- Pain associated with FNA and CNB [ Time Frame: 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019303
|United States, Utah|
|Huntsman Cancer Hospital|
|Salt Lake City, Utah, United States, 84132|