Intraoperative Molecular Diagnosis of Sentinel Lymph Node In Breast Cancer Patients
The Validation Study of the Intraoperative OSNA Molecular Assay
1 other identifier
interventional
1,500
1 country
1
Brief Summary
One-step Nucleic Acid Amplification assay (the OSNA assay) (Sysmex, Kobe, Japan) was an objective molecular technique that combines node tissue homogenization and subsequent reverse-transcription loop-mediated isothermal amplification of CK-19 mRNA in a single quick step. In the study, the performance of the OSNA assay was compared with the present standard histological evaluation, and a comparative analysis of OSNA assay with Touch Imprint Cytology (TIC) was also been made.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 27, 2019
CompletedFirst Posted
Study publicly available on registry
May 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedMay 3, 2019
May 1, 2019
10 years
April 27, 2019
May 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The accuracy, sensitivity, specificity of the OSNA assay
The accuracy, sensitivity, specificity of the OSNA assay
10 years
Study Arms (1)
SLNs were tested by the OSNA assay Intraoperatively
EXPERIMENTALSLNs were tested by the OSNA assay Intraoperatively
Interventions
SLN was defatted after SLNB. If the node weighed less than 100mg, the node was only assessed by histology postoperatively. If the node weighed more than 100mg, the node was sliced to equal blocks according to the length of short axis: If the length was less than 4mm, the node was sliced into two blocks along the long axis (a, b). Intraoperatively, the block a and b were tested by TIC, and the block a was prepared for OSNA. Postoperatively, the block b was assessed by histology. If the length was more than 4mm, the node was sliced into four blocks (a, b, c, d). Intraoperatively, all blocks (a, b, c, d) were tested by TIC, and the block a and c were prepared for OSNA.
Eligibility Criteria
You may qualify if:
- The breast cancer patients scheduled for SLNB.
You may not qualify if:
- The patients who had undergone previous ipsilateral axillary surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University
Jinan, 250117, China
Related Publications (1)
Wang YS, Ou-yang T, Wu J, Liu YH, Cao XC, Sun X, Fu L, Liao N, Yang WT, Zhong WX, Lu AP. Comparative study of one-step nucleic acid amplification assay, frozen section, and touch imprint cytology for intraoperative assessment of breast sentinel lymph node in Chinese patients. Cancer Sci. 2012 Nov;103(11):1989-93. doi: 10.1111/cas.12001. Epub 2012 Oct 18.
PMID: 22924886RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yong-sheng Wang
Shandong Cancer Hospital & Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Direct of Breast Cancer Center
Study Record Dates
First Submitted
April 27, 2019
First Posted
May 3, 2019
Study Start
February 1, 2010
Primary Completion
February 1, 2020
Study Completion
August 1, 2020
Last Updated
May 3, 2019
Record last verified: 2019-05