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Cancer Detection in Pancreatic Cysts

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.
 
ClinicalTrials.gov Identifier: NCT00222898
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 19, 2007
Sponsor:
Collaborators:
VA Pittsburgh Healthcare System
American Society for Gastrointestinal Endoscopy
Information provided by:
University of Pittsburgh

Study Description
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Brief 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

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

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.

Study Design
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Study Type : Observational
Enrollment : 300 participants
Observational Model: Defined Population
Time Perspective: Other
Official Title: Pancreatic Cyst DNA Analysis
Study Start Date : June 2004

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
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Principal Investigator: Asif Khalid, MD University of Pittsburgh
More Information
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ClinicalTrials.gov Identifier: NCT00222898    
Other Study ID Numbers: PANDA
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 19, 2007
Last Verified: February 2007
Keywords provided by University of Pittsburgh:
Pancreatic Cyst
PANDA Study
Additional relevant MeSH terms:
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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