A Prospective Study of Thin Prep Versus Papanicolau in Suspected Malignant Lesions During Endoscopic Ultrasound (EUS)

Completed

Conditions studied: Suspected Malignant Lesions

In brief

Objective: The purpose of this study was to compare the performance of the monolayer preparation (Cyto Lyt or Thin prep) to the routine use of Papanicolau methods on the analysis of specimens obtained using EUS-FNA.

Key facts

Study ID

NCT00716196

Run by

Indiana University

Starts

2005-03-01

Expected to finish

2008-07-01

Last updated by the study team

2012-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects with known or suspected malignancy (solid mass or lymph node) that are undergoing EUS will be eligible to participate in this study.
• Target lesions such as ascites and cystic lesions will not be considered for this study. However, if a patient has an abnormal solid lesion and abnormal lymph node in addition to the ascites or cystic lesion, they may still be considered for the study. That is, the solid lesions and abnormal lymph nodes are appropriate target lesions for this study.
• No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.
• Subject must provide signed written informed consent.

You may not qualify if…

• Subjects that have had a previous EUS-FNA are eligible for this study
• Target lesions such as ascites and cystic lesions will not be considered for this study.

Where it is running

• Clarian/Indiana University Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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