Sentinel Lymph Node Biopsy Clinical Trial
Official title:
The Validation Study of the Intraoperative OSNA Molecular Assay
NCT number | NCT03937414 |
Other study ID # | OSNA |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2010 |
Est. completion date | August 2020 |
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.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | August 2020 |
Est. primary completion date | February 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: The breast cancer patients scheduled for SLNB. Exclusion Criteria: The patients who had undergone previous ipsilateral axillary surgery. |
Country | Name | City | State |
---|---|---|---|
China | Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University | Jinan |
Lead Sponsor | Collaborator |
---|---|
Shandong Cancer Hospital and Institute |
China,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The accuracy, sensitivity, specificity of the OSNA assay | The accuracy, sensitivity, specificity of the OSNA assay | 10 years |
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