Stool Testing for Pancreatic Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 2/10/2018 |
| Start Date: | July 9, 2009 |
| End Date: | July 2020 |
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.
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.
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.
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.
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.
We found this trial at
1
site
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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