Clinical trial NCT00360152: Testing of Different Methods for Determining Whether Breast Cancer Has Spread to the Lymph Nodes
Official title: Minimally Invasive Staging of the Axilla in Breast Cancer: A Pilot Study to Assess the Feasibility of Axillary Ultrasound, Fine Needle Aspiration Biopsy and Molecular Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Neoplasms
Keywords: Breast Cancer
Axilla
Ultrasound
FNA
Molecular Analysis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Society for Surgical Oncologists
name: Sysmex America, Inc.
First posted: 2006-08-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Female patients, aged 18 and over.
* Patients must be newly diagnosed with clinical stage I or II breast cancer and be eligible for breast surgery and core breast biopsy of their proven breast carcinoma.

Exclusion Criteria:

* Inability to give informed consent
* Contraindications for breast surgery or biopsy

Patients with no evidence of malignancy scheduled to undergo procedures under general anesthesia must fulfill the following eligibility requirements:

* Female patients, aged 18 and over
* Patient must be scheduled to undergo a procedure under general anesthesia with access to lymph nodes that can be biopsied by FNA biopsy at minimal risk to the patient
* Patient must be willing to give informed consent
* Patient with no history of malignancy

Primary outcomes:
measure: Determine the sensitivity of AUS and real-time RT-PCR/RT-LAMP to predict the pathologic status of the axilla in breast cancer patients
timeFrame: At the time of ultrasound guidance and during definitive surgery for cancer
measure: Determine the feasibility of AUS, FNAB, and RT-PCR/RT-LAMP as an alternative to SLNB for axillary staging of breast cancer patients
timeFrame: At the time of ultrasound guidance and during definitive surgery for cancer
measure: Define baseline gene expression levels in lymph nodes by RT-PCR/RT-LAMP in patients with no evidence of malignancy undergoing procedures under general anesthesia
timeFrame: At the time of procedure under general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Julie A. Margenthaler, M.D.
role: PRINCIPAL_INVESTIGATOR
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