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Detection of Pancreatic Cancer and Pre-cancer by Stool DNA Testing: A Feasibility Study

18 Years
85 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Detection of Pancreatic Cancer and Pre-cancer by Stool DNA Testing: A Feasibility Study

Pancreatic ductal adenocarcinoma (PDC) remains the fourth leading cause of cancer-related
death in the U.S. 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 n PDC tumorigenesis.

Aim: The aim of this study is to determine if 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.

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.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Primary Outcome: Mutation rate in tumors/IPMN lesions vs. control

Outcome Description:

The primary outcome to be determined from this study is the positive mutation rates in tumor or IPMN lesions and in matched controls.

Outcome Time Frame:

30 days

Safety Issue:


Principal Investigator

Wendy K Chung, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Institutional Review Board

Study ID:




Start Date:

July 2009

Completion Date:

April 2013

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cancer
  • Intraductal Papillary Mucinous Neoplasm (IPMN)
  • Stool-based digital melt curve (DMC) assay
  • Surgical resection for pancreatic cancer
  • Hereditary Pancreatic Cancer Syndrome
  • Genetic mutations linked to pancreatic cancer
  • Pancreatic Neoplasms



Columbia University Medical Center New York, New York  10032