NCT04293497

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable pancreatic-cancer

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable pancreatic-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 29, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2021

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

February 29, 2020

Last Update Submit

August 11, 2021

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • The comparison of sensitivity between conventional staining method and new staining method

    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 Outcomes (1)

  • The evaluation of correlation index of staining at three type slides

    1 year

Study Arms (1)

Pancreatic Cancer

EXPERIMENTAL

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

Interventions

Cytology stainingDIAGNOSTIC_TEST

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

Pancreatic Cancer

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHA Bundang Medical Center

Seongnam, Bundang-gu, 13496, South Korea

Location

Gangnam Severance Hospital

Seoul, Gangnam-gu, 06229, South Korea

Location

In Ha University Hospital

Incheon, Jung-gu, 22332, South Korea

Location

Soon Chun Hyang University Hospital, Cheonan

Cheonan, Namdong-gu, 31151, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Sung III Jang, MD, PhD

    Gangnam Severance Hospital, Yonsei University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: The conventional staining method and new staining method will be performed in cytology specimens obtained from same patient.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 29, 2020

First Posted

March 3, 2020

Study Start

February 17, 2020

Primary Completion

May 12, 2021

Study Completion

July 2, 2021

Last Updated

August 13, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
1 year
Access Criteria
Primary investigator Sub primary investigator

Locations

KR(4)