Stool Testing for Pancreatic Cancer

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Pancreatic Cancer

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 Design

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Study Type :	Observational
Actual Enrollment :	158 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	Detection of Pancreatic Cancer and Pre-cancer by Stool DNA Testing: A Feasibility Study
Actual Study Start Date :	July 9, 2009
Estimated Primary Completion Date :	July 2019
Estimated Study Completion Date :	July 2020

Groups and Cohorts

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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.

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Biospecimen Retention:   Samples With DNA

• Tissue Collection: Fresh frozen resected tumor and IPMN tissue will be obtained whenever possible. All resected specimens, cancer and IPMN, will have histologic review to confirm the diagnosis. Ten slices of 10 microns each from each specimen will be prepared and sent to Mayo Clinic on dry ice.
• Stool Collection: Prior to any surgery, stool will be collected from both study and control patients. Collection containers and mailing materials will be provided to subjects at time of their recruitment. Stool specimens will be mailed directly to Mayo Clinic within 48 hours of collection. Stool will be stored at 80 °C until assayed.
• Stool DNA extraction: After stool is homogenized, crude stool DNA will be extracted and purified.
• Digital melt curve mutation analysis: Target gene copies in captured stool DNA and tissue DNA will be quantified with real-time PCR. To target the mutations detected in tumor specimens, we will utilize PCR primers that scan for specific gene abnormalities.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
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.

Criteria

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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Columbia University

Mayo Clinic

Investigators

Principal Investigator:	Wendy K Chung, MD	Columbia University

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Wendy K. Chung, Assistant Professor of Pediatrics, Molecular Genetics, Columbia University
ClinicalTrials.gov Identifier:	NCT01104129 History of Changes
Other Study ID Numbers:	AAAD8007
First Posted:	April 15, 2010
Last Update Posted:	February 8, 2018
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Wendy K. Chung, Columbia University:

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

Additional relevant MeSH terms:

Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms	Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases