Cancer Detection in Pancreatic Cysts

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

Tracking Information

• First Submitted Date: September 20, 2005
• First Posted Date: September 22, 2005
• Last Update Posted Date: February 19, 2007
• Study Start Date: June 2004
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cancer Detection in Pancreatic Cysts
• Official Title: Pancreatic Cyst DNA Analysis
• 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

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 Type: Observational
• Study Design: Observational Model: Defined Population; Time Perspective: Other
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Not Provided
• Study Population: Not Provided

Condition

• Pancreatic Cyst
• Pancreatic Pseudocyst
• Pancreatic Neoplasm

• Intervention: Procedure: DNA analysis of pancreatic cyst fluid / buccal swab
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 20, 2005): 300
• Original Enrollment: Same as current
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00222898
• Other Study ID Numbers: PANDA
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: University of Pittsburgh

Collaborators

• VA Pittsburgh Healthcare System
• American Society for Gastrointestinal Endoscopy

Investigators

• Principal Investigator: Asif Khalid, MD; University of Pittsburgh

• PRS Account: University of Pittsburgh
• Verification Date: February 2007