Stool Testing for Pancreatic Cancer

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT01104129
• Lead Sponsor: Columbia University

Brief Summary

The purpose of this study is to determine if pancreatic cancer/pre-cancer can be detected in early stages through the molecular analysis of stool samples. Investigators hypothesize that analysis of stool samples using digital melt curve (DMC) analysis, can be used as a sensitive and specific method to detect the common genetic abnormalities present in pancreatic cancers and pre-cancerous lesions of the pancreas.

Detailed Description

Pancreatic ductal adenocarcinoma (PDC) remains the fourth leading cause of cancer-related death in the United States. This is largely due to the fact that most patients present with advanced, unresectable disease, highlighting the critical need for a screening test for this disease. Stool testing is an approach that has not been explored for use in PDC screening. With the advent of stool-based DNA tests, it may be possible to target genetic abnormalities that have been recently characterized in PDC tumorigenesis.

Aim: The aim of this study is to determine if deoxyribonucleic acid (DNA) alterations present in pancreatic cancer and precancerous intrapapillary mucinous neoplasms (IPMN) can be reliably recovered in matched stool.

Methods: This is a case-control prospective study to determine the utility of a stool-based digital melt curve (DMC) assay in PDC screening. A total of 30 patients (18 with pancreatic cancer, 12 with IPMN) who will be undergoing pancreatic resection will be enrolled. Pancreatic neoplastic tissue will be isolated from their surgical specimens and the genes most commonly mutated in PDC will be sequenced from extracted DNA. In addition, hypermethylation at common promoter sites will be assessed by methylation-specific PCR. The genetic and epigenetic alterations isolated in pancreatic tissue will be utilized as the targets for stool DMC assay. Blinded technicians will process stool specimens from control patients as well as a matched control. The primary outcomes of this study will be the sensitivity and specificity of the stool DMC assay in detecting genetic mutations present in tumor or IPMN lesions.

Study Timeline

• Study Start: 2009-07-09
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-15
• Primary Completion: 2016-11-29
• Study Completion: 2016-11-29
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• 18 years of age and older.
• Tissue-confirmed or radiological evidence of either pancreatic adenocarcinoma or intrapapillary mucinous neoplasm(IPMN).
• Scheduled for surgical resection of the adenocarcinoma or IPMN.
• Able to give informed consent

Exclusion Criteria

• History of colorectal, gastric cancer, esophageal, or head-and-neck cancer.
• Endoscopic procedure conducted less than 1 week prior to enrollment.
• Unwillingness or inability to sign informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive mutation rate in tumors/IPMN lesions vs. control	30 days	The positive mutation rates in tumor or IPMN lesions and in matched controls will be assessed.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with genetic abnormalities correctly detected in stool samples	30 days	Whether or not the genetic abnormalities that are detected in resected tissue can also be detected in stool specimens will be studied. If the hypothesis proves to be true, a new, non-invasive technique used in the detection of pre-cancerous lesions of the pancreas and pancreatic cancer will thereby be determined.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States