Clinical trial NCT01104129: Stool Testing for Pancreatic Cancer
Official title: Detection of Pancreatic Cancer and Pre-cancer by Stool DNA Testing: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: 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
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2010-04-15
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Positive mutation rate in tumors/IPMN lesions vs. control
timeFrame: 30 days
Secondary outcomes:
measure: Percentage of patients with genetic abnormalities correctly detected in stool samples
timeFrame: 30 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Wendy K Chung, MD
role: PRINCIPAL_INVESTIGATOR
References: