Development of a New Immunochemistry Method Using Antibodies of Proteins Related Bile Duct Cancer

February 2, 2020 updated by: Sung III Jang, Gangnam Severance Hospital

Development of a New Immunochemistry Method Using Antibodies of Aminoacyl-tRNA Synthetases Group and Aminoacyl-transfer Ribonucleic Acid Synthetases-interacting Multifunctional protein2 Lacking Exon 2 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 develop 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

Intervention / Treatment

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 new staining method and compare with the results of conventional cytology staining method including Papanicolaou staining. Immunofluorescence or immunohistochemistry 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)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
      • Incheon, Namdong-gu, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
    • Seo-gu
      • Busan-si, Seo-gu, Korea, Republic of, 49241
        • Pusan National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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 staining will be performed in cytology specimens obtained from same patient. The cytology specimen will be obtained through brushing cytology using endoscopic retrograde cholangiopancreatography

  1. conventional cytology staining method
  2. new cytology staining method using 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
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Collaborators

Korea Institute of Science and Technology

Investigators

  • Study Chair: Institutional Review Board, Gangnam Severance Hospital, Yonsei University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2018

Primary Completion (ACTUAL)

January 22, 2020

Study Completion (ACTUAL)

January 22, 2020

Study Registration Dates

First Submitted

October 14, 2018

First Submitted That Met QC Criteria

October 14, 2018

First Posted (ACTUAL)

October 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 2, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2016-0286

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 study period.

Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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