Stool Testing for Pancreatic Cancer

NCT ID: NCT01104129

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 158 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-09
• Study Completion Date: 2016-11-29

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.

Conditions

Pancreatic Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Diagnosis of Pancreatic Cancer/IPMN

Patients diagnosed with Pancreatic Cancer/Intraductal Papillary Mucinous Neoplasm who are scheduled for surgical resection.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy K Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAD8007

Identifier Type: -

Identifier Source: org_study_id