Biospecimens for Identification of Diseases of the Pancreas. (SPORE-PANC)
|ClinicalTrials.gov Identifier: NCT01392027|
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : November 8, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Chronic Pancreatitis Type II Diabetes Pancreatic Cysts Healthy Control||Procedure: Blood Draw||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||712 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biospecimens for the Early Detection, Prevention, Diagnosis and Treatment of Diseases of the Pancreas.|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||August 31, 2017|
|Actual Study Completion Date :||August 31, 2017|
Procedure: Blood Draw
- Validation of glycoprotein panel as a pancreatic cancer biomarker [ Time Frame: 5 years ]To create a set of cases and controls to validate a novel glycoprotein panel for non-invasive or early detection of pancreatic cancer.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392027
|United States, Michigan|
|Univerisity of Michigan|
|Ann Arbor, Michigan, United States, 48109|