search
Back to results

Clinical Validation of an Immunocytochemistry Method Using MARS1 (MARS1)

Primary Purpose

Bile Duct Obstruction, Extrahepatic

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cytology staining
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bile Duct Obstruction, Extrahepatic focused on measuring bile duct obstruction, extrahepatic, cytology, aminoacyl-tRNA synthetases

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHA Bundang Medical CenterRecruiting
  • Gangnam Severance HospitalRecruiting
  • In Ha University HospitalRecruiting
  • Soon Chun Hyang University Hospital, CheonanRecruiting
  • Pusan National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bile duct stenosis

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 15, 2021
Last Updated
August 2, 2022
Sponsor
Gangnam Severance Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04759794
Brief Title
Clinical Validation of an Immunocytochemistry Method Using MARS1
Acronym
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 4, 2021 (Actual)
Primary Completion Date
January 17, 2023 (Anticipated)
Study Completion Date
January 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Obstruction, Extrahepatic
Keywords
bile duct obstruction, extrahepatic, cytology, aminoacyl-tRNA synthetases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The conventional staining method and new staining method will be performed in cytology specimens obtained from the same patient.
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bile duct stenosis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cytology staining
Intervention Description
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 Outcome Measure Information:
Title
The usefulness of new staining method
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung Ill Jang, MD, PhD
Phone
82-2-2019-3580
Email
aerojsi88@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Ill Jang, MD, PhD
Organizational Affiliation
Institutional Review Board, Gangnam Severance Hospital Yonsei University College of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
CHA Bundang Medical Center
City
Seongnam
State/Province
Bundang-gu
ZIP/Postal Code
13496
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang-Il Kwon, MD., Ph.D
Phone
+82- 031-780-5000
Email
endoscopy@cha.ac.kr
Facility Name
Gangnam Severance Hospital
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06229
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Ill Jang, MD., Ph.D
Phone
+82-2-2019-3580
Email
aerojsi88@gmail.com
Facility Name
In Ha University Hospital
City
Incheon
State/Province
Jung-gu
ZIP/Postal Code
22332
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Seuk, MD., Ph.D
Phone
+82-32-890-2548
Email
inos@inha.ac.kr
Facility Name
Soon Chun Hyang University Hospital, Cheonan
City
Cheonan
State/Province
Namdong-gu
ZIP/Postal Code
31151
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Hoon Lee, MD., Ph.D
Phone
+82-041-570-2114
Email
taewoolee9@gmail.com
Facility Name
Pusan National University Hospital
City
Busan-si
State/Province
Seo-gu
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Uk Kim, MD., Ph.D
Phone
+82-51-240-7472
Email
amlm3@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Clinical Validation of an Immunocytochemistry Method Using MARS1

We'll reach out to this number within 24 hrs