Biospecimens for Identification of Diseases of the Pancreas. (SPORE-PANC)

This study is currently recruiting participants.

Verified April 2013 by University of Michigan

Sponsor:

Information provided by (Responsible Party):

Missy Tuck, University of Michigan

ClinicalTrials.gov Identifier:

NCT01392027

First received: July 6, 2011

Last updated: April 23, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	July 6, 2011
Last Updated Date	April 23, 2013
Start Date ^ICMJE	April 2011
Estimated Primary Completion Date	September 2016 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 10, 2012)	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.
Original Primary Outcome Measures ^ICMJE (submitted: July 11, 2011)	Validation of glycoprotein panel as a pancreatic cancer biomarker [ 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.
Change History	Complete list of historical versions of study NCT01392027 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Biospecimens for Identification of Diseases of the Pancreas.
Official Title ^ICMJE	Biospecimens for the Early Detection, Prevention, Diagnosis and Treatment of Diseases of the Pancreas.
Brief Summary	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.
Detailed Description	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 ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Pancreatic Cancer Chronic Pancreatitis Type II Diabetes Pancreatic Cysts Healthy Control
Intervention ^ICMJE	Procedure: Blood Draw Blood draw for research specimens only
Study Arm (s)	No Intervention: Disease vs healthy Intervention: Procedure: Blood Draw
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	5000
Completion Date	Not Provided
Estimated Primary Completion Date	September 2016 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Overall Inclusion (all subjects must meet these criteria to be enrolled) Adults 18 years of age or older Able to physically tolerate removal of 50 ml of blood Willing to sign informed consent. Exclusion Criteria:Overall Exclusion (for all subjects) Pregnant or lactating Known HIV/AIDS or Hepatitis C Prepped for colonoscopy at the time of blood collection Unable to understand English Receiving chemotherapy or radiation at time of enrollment Any cancer within 5 years of enrollment except any of the following: Squamous cell carcinoma of the skin or Basal cell carcinoma of the skin Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery only. (Excluded if had pelvic radiation) Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01392027
Other Study ID Numbers ^ICMJE	P50-CA13081001A2
Has Data Monitoring Committee	Yes
Responsible Party	Missy Tuck, University of Michigan
Study Sponsor ^ICMJE	University of Michigan
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Michigan
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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