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Trial record 66 of 170 for:    cholangiocarcinoma | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03708445
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
Korea Institute of Science and Technology
Information provided by (Responsible Party):
Sung III Jang, Gangnam Severance Hospital

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 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.

Condition or disease Intervention/treatment Phase
Bile Duct Obstruction, Extrahepatic Diagnostic Test: Cytology staining Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The conventional staining method and new staining method will be performed in cytology specimens obtained from same patient.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708445


Contacts
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Contact: Dong Ki Lee, MD, PhD 82-2-2019-3214 dklee@yuhs.ac
Contact: Sung Ill Jang, MD, PhD 82-2-2019-3580 aerojsi88@gmail.com

Locations
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Korea, Republic of
CHA Bundang Medical Center Recruiting
Seongnam, Bundang-gu, Korea, Republic of, 13496
Contact: Chang-Il Kwon, MD., Ph.D    +82- 031-780-5000    endoscopy@cha.ac.kr   
Gangnam Severance Hospital Recruiting
Seoul, Gangnam-gu, Korea, Republic of, 06229
Contact: Sung Ill Jang, MD., Ph.D    +82-2-2019-3580    aerojsi88@gmail.com   
In Ha University Hospital Recruiting
Incheon, Jung-gu, Korea, Republic of, 22332
Contact: Jung Seuk, MD., Ph.D    +82-32-890-2548    inos@inha.ac.kr   
Soon Chun Hyang University Hospital, Cheonan Recruiting
Cheonan, Namdong-gu, Korea, Republic of, 31151
Contact: Tae Hoon Lee, MD., Ph.D    +82-041-570-2114    taewoolee9@gmail.com   
Gachon University Gil Medical Center Recruiting
Incheon, Namdong-gu, Korea, Republic of, 21565
Contact: Jae Hee Cho, MD., Ph.D    +82-1577-2299    jhcho9328@gmail.com   
Pusan National University Hospital Recruiting
Busan-si, Seo-gu, Korea, Republic of, 49241
Contact: Dong Uk Kim, MD., Ph.D    +82-51-240-7472    amlm3@hanmail.net   
Sponsors and Collaborators
Gangnam Severance Hospital
Korea Institute of Science and Technology
Investigators
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Study Chair: Institutional Review Board Gangnam Severance Hospital Yonsei University College of Medicine

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Responsible Party: Sung III Jang, Assistant professor, MD, PhD, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT03708445     History of Changes
Other Study ID Numbers: 3-2016-0286
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 1 year
Access Criteria:
  • Primary investigator
  • Sub primary investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sung III Jang, Gangnam Severance Hospital:
bile duct obstruction, extrahepatic
cytology
aminoacyl-tRNA synthetases

Additional relevant MeSH terms:
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Cholangiocarcinoma
Bile Duct Neoplasms
Cholestasis
Cholestasis, Extrahepatic
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antibodies
Immunologic Factors
Physiological Effects of Drugs