- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03937414
Intraoperative Molecular Diagnosis of Sentinel Lymph Node In Breast Cancer Patients
The Validation Study of the Intraoperative OSNA Molecular Assay
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients:
More than 1000 consecutive breast cancer patients scheduled for Sentinel Lymph Node Biopsy (SLNB) were enrolled in the study. The study was approved by the ethics committee of each center and each patient provided informed consent. The patients who had undergone previous ipsilateral axillary surgery were excluded from this study.
Sampling method:
Sentinel Lymph Node (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. Postoperatively, the block b and d were subjected to histology. ALND was only performed if the TIC results were positive.
OSNA assay:
All the assay operators attended a three-day-training course before the study. OSNA assay was performed according to the manufacturer's instructions. Three different calibrators with defined CK-19 mRNA copy concentrations were used to construct a standard curve on Sysmex RD-100i instrument. Then, node tissues were homogenized in 4ml homogenizing buffer Sysmex LYNORHAG. Afterwards, the homogenate was briefly centrifuged and directly used as a template for RT-LAMP. Amplification of CK-19 mRNA was automatically performed in SysmexTM RD-100i instrument with a ready-to-use reagent Sysmex LYNOAMP kit which consists of a primer-nucleotide-mix, enzymes and CK-19 mRNA calibrators as well as positive and negative controls. All the results were presented on the RD-100i instrument in qualitative categories [++, +, -] and further specified by CK-19 mRNA copy number/μl: ~250 copies [-], 250~5000 copies [+], and 5000~ [++]. The result [+] was comparable to the presence of a micro-metastasis, and [++] to a macro-metastasis.
Histological evaluation:
All node blocks used for histological evaluation were fixed in 10% buffered formalin and paraffin embedded. Four 4~6μm thick slides 200μm apart were taken from each block. Metastases larger than 0.2mm were considered positive in this study. Metastases were classified according to the 7th criterion of American Joint Cancer Committee. Macro-metastases (≥2mm) and micro-metastases (0.2~2mm, pT1mic) were considered node positive. Isolated tumor cells [≤0.2mm, ITCs, pT0(i+)] were considered node negative. All the slides were reviewed by a senior pathologist from another center. When there was a disagreement, a third senior pathologist was attended to make the final diagnosis. All the pathologists were blinded to the OSNA results.
Statistical methods:
The primary goal was the accuracy, sensitivity, specificity of the OSNA assay. McNemar test was performed to compare the rate between groups.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xiao Sun
- Phone Number: +8618678825207
- Email: drsunxiao@outlook.com
Study Locations
-
-
-
Jinan, China, 250117
- Recruiting
- Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University
-
Contact:
- Yong-sheng Wang
- Phone Number: +86 676-26213
- Email: wangysh2008@aliyun.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
The breast cancer patients scheduled for SLNB.
Exclusion Criteria:
The patients who had undergone previous ipsilateral axillary surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SLNs were tested by the OSNA assay Intraoperatively
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The accuracy, sensitivity, specificity of the OSNA assay
Time Frame: 10 years
|
The accuracy, sensitivity, specificity of the OSNA assay
|
10 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yong-sheng Wang, Shandong Cancer Hospital & Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OSNA
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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