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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00222898
Other study ID # PANDA
Secondary ID
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
Est. completion date
Est. primary completion date
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


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, 

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