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Cancer Detection in Pancreatic Cysts

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00222898
First Posted: September 22, 2005
Last Update Posted: February 19, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
VA Pittsburgh Healthcare System
American Society for Gastrointestinal Endoscopy
Information provided by:
University of Pittsburgh
  Purpose
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

Condition Intervention
Pancreatic Cyst Pancreatic Pseudocyst Pancreatic Neoplasm Procedure: DNA analysis of pancreatic cyst fluid / buccal swab

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
Official Title: Pancreatic Cyst DNA Analysis

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Estimated Enrollment: 300
Study Start Date: June 2004
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously scheduled for Endoscopic ULtrasound for evaluation of pancreatic cyst

Exclusion Criteria:

  • Any condition that would preclude safe performance of EUS/FNA
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222898


Locations
United States, Indiana
Indiana University - Purdue University Indianapolis
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Partners HealthCare System
Boston, Massachusetts, United States, 02114
United States, Missouri
Washington University Medical Center
St. Louis, Missouri, United States, 63110
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
University of Pittsburgh
VA Pittsburgh Healthcare System
American Society for Gastrointestinal Endoscopy
Investigators
Principal Investigator: Asif Khalid, MD University of Pittsburgh
  More Information

ClinicalTrials.gov Identifier: NCT00222898     History of Changes
Other Study ID Numbers: PANDA
First Submitted: September 20, 2005
First Posted: September 22, 2005
Last Update Posted: February 19, 2007
Last Verified: February 2007

Keywords provided by University of Pittsburgh:
Pancreatic Cyst
PANDA Study

Additional relevant MeSH terms:
Cysts
Pancreatic Neoplasms
Pancreatic Cyst
Pancreatic Pseudocyst
Neoplasms
Pathological Conditions, Anatomical
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases