Pancreatic Cancer Clinical Trial
Official title:
Biospecimens for the Early Detection, Prevention, Diagnosis and Treatment of Diseases of the Pancreas.
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).
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