Accuracy of FNA Versus CNB of Abnormal Axillary Lymph Nodes in Setting of Invasive Breast Cancer

• Sponsor: University of Utah (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02019303
• Collaborator: Huntsman Cancer Institute (Other)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 82
• Patients Per Site Per Month: 1.2

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Procedure: FNA and Core biopsy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Primary Purpose: Diagnostic
• 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: Feb 1, 2014
• Actual Primary Completion Date: Aug 1, 2019
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Outcome Measures

Primary Outcome Measures

1. Accuracy of FNA and CNB [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.

Secondary Outcome Measures

1. Pain associated with FNA and CNB [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huntsman Cancer Hospital	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• University of Utah
• Huntsman Cancer Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nicole Winkler, M.D., University of Utah
• ClinicalTrials.gov Identifier: NCT02019303
• Other Study ID Numbers: 00068472
• First Posted: Dec 24, 2013
• Last Update Posted: Jan 30, 2020
• Last Verified: Jan 1, 2020

• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jan 30, 2020