Biospecimens for Identification of Diseases of the Pancreas. (SPORE-PANC)
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.
Type II Diabetes
Procedure: Blood Draw
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Biospecimens for the Early Detection, Prevention, Diagnosis and Treatment of Diseases of the Pancreas.|
- Validation of glycoprotein panel as a pancreatic cancer biomarker [ Time Frame: 5 years ] [ Designated as safety issue: No ]To create a set of cases and controls to validate a novel glycoprotein panel for non-invasive or early detection of pancreatic cancer.
|Study Start Date:||April 2011|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
|No Intervention: Disease vs healthy||
Procedure: Blood Draw
Blood draw for research specimens only
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392027
|United States, Michigan|
|Univerisity of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Missy Tuck, M.S. 734-763-1141 firstname.lastname@example.org|
|Principal Investigator: Michelle A Anderson, M.D., M.P.H|