NCT04759794

Clinical Validation of an Immunocytochemistry Method Using MARS1

Clinical Validation of an Immunocytochemistry Method Using Antibody of Methionyl-tRNA Synthetase (MARS1) in the Bile Duct Cancer Cell; Multicenter Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bile Duct Obstruction, Extrahepatic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cytology staining	Two stainings will be performed in cytology specimens obtained from the same patient. The cytology specimen will be obtained through brushing cytology using endoscopic retrograde cholangiopancreatography 1. conventional cytology staining method 2. new cytology staining method using the antibody of aminoacyl-tRNA synthetases

Timeline

• Start date: 2021-02-04
• Primary completion: 2023-02-03
• Completion: 2023-02-03
• First posted: 2021-02-18
• Last updated: 2025-03-13

Locations

5 sites across 1 country: South Korea