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

Sponsor
Gangnam Severance Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04293497
Collaborator
(none)
97
Enrollment
4
Locations
1
Arm
16.5
Actual Duration (Months)
24.3
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Cytology staining
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
97 participants
Allocation:
N/A
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.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:
Clinical Validation of a New Immunochemistry Method Using Antibody of Methionyl-tRNA synthetase1(MARS1) in the Pancreatic Cancer Cell; Multicenter Prospective Study
Actual Study Start Date :
Feb 17, 2020
Actual Primary Completion Date :
May 12, 2021
Actual Study Completion Date :
Jul 2, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The comparison of sensitivity between conventional staining method and new staining method [1 year]

    The sensitivity of new staining method will be compared with the conventional Pap staining of endoscopic ultrasound-guided fine-needle aspiration cytology

Secondary Outcome Measures

  1. The evaluation of correlation index of staining at three type slides [1 year]

    The correlation index of the new staining method will be evaluated at three type slides such as Thinprep, Surepath, and Direct smear.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHA Bundang Medical Center Seongnam Bundang-gu Korea, Republic of 13496
2 Gangnam Severance Hospital Seoul Gangnam-gu Korea, Republic of 06229
3 In Ha University Hospital Incheon Jung-gu Korea, Republic of 22332
4 Soon Chun Hyang University Hospital, Cheonan Cheonan Namdong-gu Korea, Republic of 31151

Sponsors and Collaborators

  • Gangnam Severance Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sung III Jang, Associate professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT04293497
Other Study ID Numbers:
  • 3-2019-0410
First Posted:
Mar 3, 2020
Last Update Posted:
Aug 13, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pancreatic Neoplasms

Study Results

No Results Posted as of Aug 13, 2021