Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Sponsor Columbia University
Collaborator Mayo Clinic
Start date July 2009
End date December 2016
Trial size 200 participants
Trial identifier NCT01104129, AAAD8007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Individual who has not had pancreatic cancer/IPMN; surgical resection for lesion of pancreas; history of colorectal, gastric cancer, esophageal, or head-and-neck cancer; administration of chemotherapy less than 1 week prior to enrollment; or an endoscopic procedure conducted less than 1 week prior to enrollment.
Patients diagnosed with Pancreatic Cancer/Intraductal Papillary Mucinous Neoplasm who are scheduled for surgical resection.

Primary Outcomes

Measure
Positive mutation rate in tumors/IPMN lesions vs. control
time frame: 30 days

Secondary Outcomes

Measure
Percentage of patients with genetic abnormalities correctly detected in stool samples
time frame: 30 days

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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.

Additional Information

Official title Detection of Pancreatic Cancer and Pre-cancer by Stool DNA Testing: A Feasibility Study
Principal investigator Wendy K Chung, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Columbia University.