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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2019-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

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.

Group Type OTHER

FNA and Core biopsy

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huntsman Cancer Institute

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Nicole Winkler

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Huntsman Cancer Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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00068472

Identifier Type: -

Identifier Source: org_study_id

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