Stool Testing for Pancreatic Cancer

January 14, 2021 updated by: Columbia University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals with a diagnosis of pancreatic cancer/IPMN who are scheduled for surgical resection at Columbia University Medical Center's Pancreas Center will be accrued to this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control Group
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.
Diagnosis of Pancreatic Cancer/IPMN
Patients diagnosed with Pancreatic Cancer/Intraductal Papillary Mucinous Neoplasm who are scheduled for surgical resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive mutation rate in tumors/IPMN lesions vs. control
Time Frame: 30 days
The positive mutation rates in tumor or IPMN lesions and in matched controls will be assessed.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with genetic abnormalities correctly detected in stool samples
Time Frame: 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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2009

Primary Completion (Actual)

November 29, 2016

Study Completion (Actual)

November 29, 2016

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (Estimate)

April 15, 2010

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAD8007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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