- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02005926
The Accuracy of Sentinel Node Biopsy of Breast Cancer With Sonographic Abnormal Axillary Lymph Nodes
June 16, 2014 updated by: Tao OUYANG
Phase II Trail of Removing Sonographic Abnormal Lymph Node in Sentinel Lymph Node Biopsy of Breast Cancer Patient
- This is a phase II, prospective, single-center, non-randomized, non-controlled study.
- Sentinel lymph node biopsy (SNB) is a standard staging procedure in early breast cancer. The potentially increasing false negative rate of SNB was concerned if the sonographic abnormal node was not excised. The aim of this study was to evaluate the accuracy of SNB in breast cancer with sonographic abnormal axillary lymph nodes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 2
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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Beijing, China, 100142
- Breast cancer, Peking University Cancer Hospital & Institute
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- histologically confirmsed primary breast cancer by core neelde biopsy or excisional biospy
- abnormal axillary lymph node was found by ultrasound examination before SLNB (abnormal nodes were defined as completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation and cortical thickness >3mm)
- ultrasound-guided FNA cytology of these nodes were performed
- the result of FNA cytology was negative (no tumour cell was found)
- patient planed to perform SLNB
Exclusion Criteria:
- pathological diagnosed ductal carcinoma in situ by excisional biospy
- abnormal axillary lymph node was found by ultrasound examination but FNA cytology of these nodes were not performed
- the result of FNA cytology was positive (tumour cell was found)
- T4d tumour
- patient has recieved neo-adjuvant system therapy
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: negative FNA result of abnormal node
Axillary ultrasound examination was undergone for all breast cancer patients before sentinel lymph node biopsy (SLNB).
If abnormal axillary lymph node was found, ultrasound-guided FNA cytology of these nodes were performed.
The abnormal nodes were defined as completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation and cortical thickness >3mm.
Patients with negative results of FNA would undergo SLNB.
Technetium-99m-labeled Rituximab was used for lymphatic mapping.
Before the SLNB operation, a hookwire was placed at the suspicious axillary lymph node by ultrasound guidance.
In the SLNB operation, radioactive nodes and wire-localized nodes were removed and labeled separately for pathological examination.
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Before the sentinel lymph node biopsy (SLNB) operation, a hookwire was placed at the suspicious axillary lymph node by ultrasound guidance to localize the abnormal node.
In the SLNB operation, radioactive nodes and wire-localized nodes were removed and labeled separately for pathological examination.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
False negative rate of sentinel node biopsy if sonographic abnormal node not be removed
Time Frame: one week after sentinel node biopsy
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one week after sentinel node biopsy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zhaoqing Fan, M.D., Peking University Cancer Hospital & Institute
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
May 1, 2010
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
December 4, 2013
First Submitted That Met QC Criteria
December 4, 2013
First Posted (Estimate)
December 9, 2013
Study Record Updates
Last Update Posted (Estimate)
June 18, 2014
Last Update Submitted That Met QC Criteria
June 16, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCP07
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.
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