Cancer Detection in Pancreatic Cysts

Pancreatic Neoplasm Clinical Trial

Official title:

Pancreatic Cyst DNA Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222898
• Other study ID #: PANDA
• Status: Completed
• Phase: N/A
• First received: September 20, 2005
• Last updated: February 16, 2007
• Start date: June 2004

Study information

• Verified date: February 2007
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assist with early and accurate diagnosis of cancer in pancreatic cysts based on the analysis of DNA obtained by endoscopic ultrasound guided fine needle aspiration

Description:

The study of pancreatic diseases is hindered by the organ's deep seated location and especially lack of symptoms during the early stages of disease development and progression e.g. pancreatic cancer. This is particularly true of pancreatic cysts, the variety and the malignant potential of which encompass a broad spectrum. The radiological features distinguishing a benign from a pre-malignant to a frankly malignant cyst in the pancreas are frequently underwhelming and have lead to the clinical practice of sampling all but the most obvious. The yield of the aspirate in turn is frequently not of a quality upon which a clinical decision can be based.

Most would agree that the best approach for management of pancreatic cystic neoplasm lies in early diagnosis, ideally at a precancerous stage. The effectiveness and applicability of this study is the based on the ability of the cyst DNA analysis to stratify the patients at risk of developing pancreatic cancer based on the extent of accumulated mutational damage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previously scheduled for Endoscopic ULtrasound for evaluation of pancreatic cyst

Exclusion Criteria:

• Any condition that would preclude safe performance of EUS/FNA

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Cysts
• Pancreatic Cyst
• Pancreatic Neoplasm
• Pancreatic Neoplasms
• Pancreatic Pseudocyst

Intervention

Procedure:
• DNA analysis of pancreatic cyst fluid / buccal swab

Locations

Country	Name	City	State
United States	Partners HealthCare System	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Indiana University - Purdue University Indianapolis	Indianapolis	Indiana
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania
United States	Washington University Medical Center	St. Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	American Society for Gastrointestinal Endoscopy, VA Pittsburgh Healthcare System

Country where clinical trial is conducted

United States,