Clinical Validation of an Immunocytochemistry Method Using MARS1 (MARS1)

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

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.

Study Overview

• Status: Completed
• Conditions: Bile Duct Obstruction, Extrahepatic
• Intervention / Treatment: Diagnostic test: Cytology staining

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bundang-gu
    • Seongnam, Bundang-gu, Korea, Republic of, 13496
      • Cha Bundang Medical Center
  • Gangnam-gu
    • Seoul, Gangnam-gu, Korea, Republic of, 06229
      • Gangnam Severance Hospital
  • Jung-gu
    • Incheon, Jung-gu, Korea, Republic of, 22332
      • In Ha University Hospital
  • Namdong-gu
    • Cheonan, Namdong-gu, Korea, Republic of, 31151
      • Soon Chun Hyang University Hospital, Cheonan
  • Seo-gu
    • Busan-si, Seo-gu, Korea, Republic of, 49241
      • Pusan National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bile duct stenosis; This arm includes patients with bile duct stenosis. Endobiliary brushing cytology specimens will be obtained with endoscopic retrograde cholangiopancreatography (ERCP) of patients with bile duct stenosis. Cytology staining will be performed in the cytology specimens.	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; conventional cytology staining method; new cytology staining method using the antibody of aminoacyl-tRNA synthetases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The usefulness of new staining method	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.	1 year

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital
• Investigators: Study Chair: Sung Ill Jang, MD, PhD, Institutional Review Board, Gangnam Severance Hospital Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2021
• Primary Completion (Actual): February 3, 2023
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: cytology; bile duct obstruction, extrahepatic; aminoacyl-tRNA synthetases
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis; Cholestasis, Extrahepatic
• Other Study ID Numbers: 3-2020-0514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to share the following individual participant data with other researchers during the study period.
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: Primary investigator; Sub primary investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No