Clinical trial NCT04759794: Clinical Validation of an Immunocytochemistry Method Using MARS1
Official title: Clinical Validation of an Immunocytochemistry Method Using Antibody of Methionyl-tRNA Synthetase (MARS1) in the Bile Duct Cancer Cell; Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bile Duct Obstruction, Extrahepatic
Keywords: bile duct obstruction, extrahepatic
cytology
aminoacyl-tRNA synthetases
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 55
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The conventional staining method and new staining method will be performed in cytology specimens obtained from the same patient.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: The usefulness of new staining method
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Bundang-gu
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
state: Gangnam-gu
city: Incheon
country: Korea, Republic of
facility: In Ha University Hospital
state: Jung-gu
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital, Cheonan
state: Namdong-gu
city: Busan-si
country: Korea, Republic of
facility: Pusan National University Hospital
state: Seo-gu
Study officials:
affiliation: Institutional Review Board, Gangnam Severance Hospital Yonsei University College of Medicine
name: Sung Ill Jang, MD, PhD
role: STUDY_CHAIR
References: