Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intraoperative Molecular Diagnosis of Sentinel Lymph Node In Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937414
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Yongsheng Wang, Shandong Cancer Hospital and Institute

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.

Condition or disease Intervention/treatment Phase
Sentinel Lymph Node Biopsy Device: The OSNA assay Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Validation Study of the Intraoperative OSNA Molecular Assay
Actual Study Start Date : February 1, 2010
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: SLNs were tested by the OSNA assay Intraoperatively
SLNs were tested by the OSNA assay Intraoperatively
Device: The OSNA assay
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.




Primary Outcome Measures :
  1. The accuracy, sensitivity, specificity of the OSNA assay [ Time Frame: 10 years ]
    The accuracy, sensitivity, specificity of the OSNA assay



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The breast cancer patients scheduled for SLNB.

Exclusion Criteria:

The patients who had undergone previous ipsilateral axillary surgery.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937414


Contacts
Layout table for location contacts
Contact: Xiao Sun +8618678825207 drsunxiao@outlook.com

Locations
Layout table for location information
China
Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University Recruiting
Jinan, China, 250117
Contact: Yong-sheng Wang    +86 676-26213    wangysh2008@aliyun.com   
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Investigators
Layout table for investigator information
Principal Investigator: Yong-sheng Wang Shandong Cancer Hospital & Institute
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Yongsheng Wang, Direct of Breast Cancer Center, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT03937414    
Other Study ID Numbers: OSNA
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Keywords provided by Yongsheng Wang, Shandong Cancer Hospital and Institute:
Breast neoplasm; Molecular Diagnostic Techniques