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NCT00360152 · ClinicalTrials.gov registry record · Early Phase 1
Testing of Different Methods for Determining Whether Breast Cancer Has Spread to the Lymph Nodes
A Early Phase 1 study of Breast Neoplasms, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT00360152 is a Early Phase 1 study of Breast Neoplasms that has completed, run by Washington University School of Medicine. The registered enrollment target is 100 participants, below the 568-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00360152, a Early Phase 1 study of Breast Neoplasms, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- PROCEDURE Sentinel Lymph Node Biopsy
- PROCEDURE Fine needle aspiration biopsy (FNAB)
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2006-08 |
| Est. Completion | 2013-04 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00360152
The ClinicalTrials.gov registry entry for NCT00360152 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 568-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (82% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Sentinel Lymph Node Biopsy is the first listed.
NCT00360152 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT00360152 about?
NCT00360152 is a clinical study titled "Testing of Different Methods for Determining Whether Breast Cancer Has Spread to the Lymph Nodes". 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 hy...
What is the current status of trial NCT00360152?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 100 participants. The study started on 2006-08. Estimated completion is 2013-04.
What conditions does trial NCT00360152 study?
This clinical trial studies the following conditions: Breast Neoplasms.
What interventions are being tested in trial NCT00360152?
The interventions under investigation include: Sentinel Lymph Node Biopsy (PROCEDURE), Fine needle aspiration biopsy (FNAB) (PROCEDURE).
Who is sponsoring clinical trial NCT00360152?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00360152 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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