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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Procedure: Fine needle aspiration biopsy (FNAB)
* Procedure: Sentinel Lymph Node Biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Positive Axillary Ultrasound<br>Positive Axillary Ultrasound -> Fine Needle Aspiration Biopsy -> Cytopathology and Reverse Transcription-Polymerase Chain Reaction (RT-PCR) -> Positive Cyto=Axillary Lymph Node Dissection, Negative Cyto=Sentinel Lymph Node Biopsy -> Pathology | Procedure: Fine needle aspiration biopsy (FNAB)<br> <br> Procedure: Sentinel Lymph Node Biopsy<br> <br> |
| Active Comparator: Negative Axillary Ultrasound<br>Negative Axillary Ultrasound -> Sentinel Lymph Node Biopsy/Fine Needle Aspiration Biopsy -> Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and Pathology | Procedure: Fine needle aspiration biopsy (FNAB)<br> <br> Procedure: Sentinel Lymph Node Biopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the sensitivity of AUS and real-time RT-PCR/RT-LAMP to predict the pathologic status of the axilla in breast cancer patients |  | At the time of ultrasound guidance and during definitive surgery for cancer | 
| Determine the feasibility of AUS, FNAB, and RT-PCR/RT-LAMP as an alternative to SLNB for axillary staging of breast cancer patients |  | At the time of ultrasound guidance and during definitive surgery for cancer | 
| 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 |  | At the time of procedure under general anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FNA, Breast Cancer, Axilla, Ultrasound, Molecular Analysis