Development of a New Immunochemistry Method Using Antibodies of Proteins Related Pancreatic Cancer

August 11, 2021 updated by: Sung III Jang, Gangnam Severance Hospital

Clinical Validation of a New Immunochemistry Method Using Antibody of Methionyl-tRNA synthetase1(MARS1) in the Pancreatic Cancer Cell; Multicenter Prospective Study

Identifying the malignancy of pancreatic mass using endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is important for treatment decision-making and prognosis prediction. The sensitivity of EUS-FNA cytology specimens based on Papanicolaou (Pap) staining is low, which hampers accurate diagnosis of pancreatic mass. We assessed the diagnostic value of immunohistochemical (IHC) and immunofluorescence (IF) staining for methionyl-tRNA synthetase 1 (MARS1).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND / AIMS: The sensitivity of endoscopic ultrasound-guided aspiration cytology used to distinguish the pancreatic mass is low and clinical usefulness is not secured. The aim of this study was to evaluate clinical efficacy of a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using pancreatic cancer related protein expressed only in pancreatic cancer.

Hypothesis: The statistical significance between conventional staining method and MARS1 staining in the pancreatic cancer cells collected by endoscopic ultrasound-guided aspiration will be compared to prove the usefulness of the new staining method.

Clinical study design: The expression of MARS1 in the pancreatic cancer cell line obtained by endoscopic ultrasound in patients suspected of having pancreatic cancer using 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)

97

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

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:

  1. Patients with pancreatic cancer confirmed by imaging (CT, MRI, PET-CT)
  2. Patients with pancreatic cancer diagnosed using cytology by endoscopic ultrasound
  3. Patients who underwent surgical treatment with pancreatic cancer

Exclusion Criteria:

  1. Minors under the age of 19, vulnerable subjects such as illiteracy
  2. Excludes necrotic specimens
  3. Samples with non-diagnostic cytology results and insufficient cells for further evaluation
  4. Samples classified as neoplastic (benign or other)

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: Pancreatic Cancer
This arm includes patients with pancreatic cancer. Cytology specimens will be obtained with endoscopic ultrasound-guided fine-needle aspiration in patients with pancreatic cancer. 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 using endoscopic ultrasound-guided fine needle aspiration. Three types of slides (direct smear, thinprep, surepath) are prepared for staining.

  1. conventional cytology staining method
  2. new cytology staining method using antibody of methionyl-tRNA synthetase 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The comparison of sensitivity between conventional staining method and new staining method
Time Frame: 1 year
The sensitivity of new staining method will be compared with the conventional Pap staining of endoscopic ultrasound-guided fine-needle aspiration cytology
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The evaluation of correlation index of staining at three type slides
Time Frame: 1 year
The correlation index of the new staining method will be evaluated at three type slides such as Thinprep, Surepath, and Direct smear.
1 year

Collaborators and Investigators

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

Sponsor

Gangnam Severance Hospital

Investigators

  • Principal Investigator: Sung III Jang, MD, PhD, Gangnam Severance Hospital, Yonsei University College of Medicine

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)

February 17, 2020

Primary Completion (ACTUAL)

May 12, 2021

Study Completion (ACTUAL)

July 2, 2021

Study Registration Dates

First Submitted

February 29, 2020

First Submitted That Met QC Criteria

February 29, 2020

First Posted (ACTUAL)

March 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2019-0410

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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