Clinical Validation of an Immunocytochemistry Method Using MARS1

Bile Duct Obstruction, Extrahepatic Clinical Trial

— MARS1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04759794
• Other study ID #: 3-2020-0514
• Status: Recruiting
• Phase: N/A
• Start date: February 4, 2021
• Est. completion date: January 17, 2023

Study information

• Verified date: August 2022
• Source: Gangnam Severance Hospital
• Contact: Sung Ill Jang, MD, PhD
• Phone: 82-2-2019-3580
• Email: aerojsi88[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 17, 2023
• Est. primary completion date: January 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Obstruction, Extrahepatic
• Cholestasis
• Cholestasis, Extrahepatic

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan-si	Seo-gu
Korea, Republic of	Soon Chun Hyang University Hospital, Cheonan	Cheonan	Namdong-gu
Korea, Republic of	In Ha University Hospital	Incheon	Jung-gu
Korea, Republic of	CHA Bundang Medical Center	Seongnam	Bundang-gu
Korea, Republic of	Gangnam Severance Hospital	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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