An interventional study of Blood Draw in Pancreatic Cancer, Chronic Pancreatitis and Type II Diabetes, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-08.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
This proposed project is designed to collect data and specimens from patients/subjects presenting to the University of Michigan with a disease affecting the pancreas (or specific control populations). This protocol is focused on collecting data, blood samples, and tissue on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts, pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy controls.
We are collecting up to 50 mls of blood for research purposes only. Plasma, serum and buffy coat are collected and stored according to strict SOPs.
The recently funded GI SPORE, here at the University of Michigan, is focused on pancreatic and colon diseases. This protocol is focused on collecting data, blood samples, and tissue on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts, pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy controls. A SPORE is an NCI-funded, Specialized Program in Research Excellence, with specific requirements. Those requirements include 4 projects with a clinical and a basic science Co-PI and several COREs, including a biospecimen core. Each project that has a human subjects component will require a separate protocol and IRB submission when those projects are to begin.
The specific populations we are recruiting are determined by the aims of project 2 and by the need to create a repository as part of the biospecimen core (please see the grant for details on the aims of these 2 projects).
A specially designed database is being built for this study to handle the data aspects. Our collaborators at Dartmouth College have significant experience in managing data as they have been our partners for our work in the EDRN (PI Brenner). Case report forms and other data collection tools have been developed and are being used to populate the database. All of the actual data will be completely deidentified per HIPAA regulations.
We intend to model the data and specimen collection on the model used by our work with the NCI-EDRN. This includes a customized database, the use of kits with pre-labled, bar-coded aliquots, and standardized data collection forms (CRFs).
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 712 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Overall Inclusion (all subjects must meet these criteria to be enrolled)
Exclusion Criteria:Overall Exclusion (for all subjects)
Any cancer within 5 years of enrollment except any of the following:
Blood draw for research specimens only
Validation of glycoprotein panel as a pancreatic cancer biomarker
To create a set of cases and controls to validate a novel glycoprotein panel for non-invasive or early detection of pancreatic cancer.
Time frame: 5 years
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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University of Michigan