Validity of Sentinel Lymphnode Biopsy After Neoadjuvant Chemotherapy Cancer Patients With Radiologically Positive Axillary Lymph Nodes (VSNBNAC)
August 14, 2012 updated by: Sung Gwe Ahn, Gangnam Severance Hospital
Validity of Sentinel Lymphnode Biopsy After Neoadjuvant Chemotherapy in Breast Cancer Patients With Radiologically Positive Axillary Lymph Nodes
Sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NAC) is currently debatable.
It is possible that the tumor response to chemotherapy may alter the lymphatic drainage thus causing lower SLN identification rate and higher false negative rate.
Further, the response of NAC can be different in each lymph nodes.
It is doubtful whether SLNB can accurately predict axillary lymph node (ALN) status after NAC.
The aim of this study to determine the identification rate, the false-negative rate, and the accuracy of SLNB after NAC for node positive breast cancer.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 135270
- Gangnam Severance Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Advanced breast cancer patients with node-positive proved in preoperative imaging study
Description
Inclusion Criteria:
- Advanced breast cancer patients with node-positive proved in preoperative imaging study
- ECOG status 0-1
Exclusion Criteria:
- No previous cancer history
- No previous chemotherapy history
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Clinically node-positive patients before NAC
Patients with clinically positive lymph node receiving neoadjuvant chemotherapy
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Sentinel lymph node biopsy after neoadjuvant chemotherapy for the patients with clinically positive-nodes at presentation
Neoadjuvant chemotherapy for breast cancer patients with clinically positive-node at initial diagnosis
Complete axillary lymph node dissection after sentinel node biopsy for estimation of false-negative rate of sentinel node biopsy
Routine evaluation of axillary nodal status using 18-fluorodeoxyglucose positron emission tomography and ultrasonogram before and after chemotherapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
June 15, 2012
First Submitted That Met QC Criteria
June 18, 2012
First Posted (Estimate)
June 19, 2012
Study Record Updates
Last Update Posted (Estimate)
August 15, 2012
Last Update Submitted That Met QC Criteria
August 14, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GNSBCC001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.