Clinical Validation of an Immunocytochemistry Method Using MARS1

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.

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Key information

Conditions

Bile Duct Obstruction, Extrahepatic Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Extrahepatic Digestive System Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHA Bundang Medical Center, Seongnam, Bundang-gu, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with biliary cancer confirmed by imaging (CT, MRI, positron emission tomography)
Patients with bile duct cancer diagnosed using brushing cytology by endoscopic retrograde pancreaticoduodenoscopy
Patients who underwent surgical treatment with biliary cancer
Patients with bile duct stenosis

Exclusion criteria

Minors under the age of 19, vulnerable subjects such as illiteracy
Necrotic specimens
Samples with non-diagnostic cytology results and insufficient cells for further evaluation
Samples classified as neoplastic (benign or other)
Patient with cholangitis in the bile duct

Treatment and study plan

Cytology staining

Diagnostic Test

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

conventional cytology staining method
new cytology staining method using the antibody of aminoacyl-tRNA synthetases

Primary outcomes

The usefulness of new staining method

Time frame: 1 year

The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of new staining method will be compared with th conventional Pap staining of brushing cytology specimens.

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Acronym: MARS1

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Feb 18, 2021
Registry last updated: Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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