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Testing of Different Methods for Determining Whether Breast Cancer Has Spread to the Lymph Nodes

NCT00360152 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-07-04

No results posted yet for this study

Summary

Sentinel lymph node biopsy (SLNB) has recently emerged as a less invasive alternative to axillary lymph node dissection (ALND) in the treatment of breast cancer. However, SLNB has a number of limitations, and we believe that alternative strategies for staging of the axilla should be explored. The hypothesis of this proposal is that the combination of preoperative high-resolution axillary ultrasound (AUS), fine needle aspiration biopsy (FNAB), and molecular analysis using real-time reverse transcription-polymerase chain reaction (RT-PCR) represents a viable, minimally invasive alternative to SLNB. We propose a prospective cohort study to rigorously assess the diagnostic accuracy of molecular analysis of AUS-FNAB specimens. The primary endpoint of this study is to determine the feasibility of AUS-FNAB and real-time RT-PCR to predict the pathologic status of the axilla in a proof-of-principle study. In the short term, validation of this innovative strategy is likely to reduce the number of sentinel node procedures. In the long term, we believe that AUS-FNAB may ultimately replace SLNB.

Conditions

  • Breast Neoplasms

Interventions

PROCEDURE

Fine needle aspiration biopsy (FNAB)

PROCEDURE

Sentinel Lymph Node Biopsy

Sponsors & Collaborators

  • Society for Surgical Oncologists

    collaborator UNKNOWN

  • Sysmex America, Inc.

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Julie A. Margenthaler, M.D. · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2009-01-31
Completion
2013-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00360152 on ClinicalTrials.gov