NCT02190071

Brief Summary

The purpose of this study is to determine whether there is a difference of diagnostic accuracy between cover slides and base slides from EUS-FNA cytopathologic sample in patients who were previously suspected of pancreatic cancer in radiologic test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

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

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 27, 2016

Status Verified

July 1, 2015

Enrollment Period

1.8 years

First QC Date

July 6, 2014

Last Update Submit

May 25, 2016

Conditions

Pancreatic Cancer

Keywords

EUS-FNAcytopathologyslide smear

Outcome Measures

Primary Outcomes (1)

  • positive malignancy rate of cover slides set and base slides set.

    comparison between diagnostic accuracy between cover slide sets and base slide sets

    cytopathological report within 2 weeks after EUS-FNA

Secondary Outcomes (1)

  • positive malignancy rate of (1) cytologic smear, (2) cell block and (3) histologic biopsy

    record of pathologist within 2 weeks after EUS-FNA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who visited to tertiary medical center(Seoul National University Bundang Hospital) because of suspicious pancreatic cancer in radiologic study

You may qualify if:

  • patients who were suspected of pancreatic cancer in previous radiologic test such as computed tomography, magnetic resonance imaging or Positron Emission Tomography.

You may not qualify if:

  • failed smear due to inexperienced assistant
  • loss of slide
  • patients who were diagnosed with other lesion far from pancreatic cancer in prospective confirmative tests.
  • patients who refuse to participate in this study
  • report of other pathologist who are not a previously-assigned pathologist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

One identical and skilled endoscopist's EUS-FNA sampling with multiple punctures

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jaihwan Kim, M.D.

    Seoul National University Bundang Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2014

First Posted

July 15, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 27, 2016

Record last verified: 2015-07

Locations

KR(1)