Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759794
Status:
UNKNOWN
Last Update Posted:
2022-08-03
First Post:
2021-02-15
Brief Title:
Clinical Validation of an Immunocytochemistry Method Using MARS1
Sponsor:
Gangnam Severance Hospital
Organization:
Gangnam Severance Hospital
Study Overview
Official Title:
Clinical Validation of an Immunocytochemistry Method Using Antibody of Methionyl-tRNA Synthetase MARS1 in the Bile Duct Cancer Cell Multicenter Study
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MARS1
Brief Summary:
The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured The aim of this study was to validate the clinical usefulness of a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using biliary cancer-related protein expressed only in bile duct cancer
Detailed Description:
Hypothesis The statistical significance of new staining method using aminoacyl-tRNA synthetases ARSs group in normal bile duct cells and the bile duct cancer cells collected by endoscopic retrograde pancreaticoduodenoscopy ERCP will be compared to prove the usefulness of the new staining method
Clinical study design The bile duct cytology will be obtained by brushing cytology using ERCP in patients with biliary stenosis The expression of ARSs in the brushing cytology will be evaluated by a new staining method and compare with the results of the conventional cytology staining method including Papanicolaou staining Immunofluorescence or immunocytochemistry staining will be performed to differentiate the presence of the tumor The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed
Clinical study design The bile duct cytology will be obtained by brushing cytology using ERCP in patients with biliary stenosis The expression of ARSs in the brushing cytology will be evaluated by a new staining method and compare with the results of the conventional cytology staining method including Papanicolaou staining Immunofluorescence or immunocytochemistry staining will be performed to differentiate the presence of the tumor The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None