Pancreatic Cancer Clinical Trial
Official title:
Detection of Pancreatic Cancer and Pre-cancer by Stool DNA Testing: A Feasibility Study
NCT number | NCT01104129 |
Other study ID # | AAAD8007 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 9, 2009 |
Est. completion date | November 29, 2016 |
Verified date | January 2021 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 158 |
Est. completion date | November 29, 2016 |
Est. primary completion date | November 29, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive mutation rate in tumors/IPMN lesions vs. control | The positive mutation rates in tumor or IPMN lesions and in matched controls will be assessed. | 30 days | |
Secondary | Percentage of patients with genetic abnormalities correctly detected in stool samples | 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 |
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