Cancer Detection in Pancreatic Cysts

This study has been completed.
Sponsor:
Collaborators:
VA Pittsburgh Healthcare System
American Society for Gastrointestinal Endoscopy
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00222898
First received: September 20, 2005
Last updated: February 16, 2007
Last verified: February 2007
  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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00222898     History of Changes
Other Study ID Numbers: PANDA
Study First Received: September 20, 2005
Last Updated: February 16, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Pancreatic Cyst
PANDA Study

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

ClinicalTrials.gov processed this record on October 23, 2014