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Biospecimens for the Early Detection, Prevention, Diagnosis and Treatment of Diseases of the Pancreas.

18 Years
Open (Enrolling)
Pancreatic Cancer, Chronic Pancreatitis, Type II Diabetes, Pancreatic Cysts, Healthy Control

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Trial Information

Biospecimens for the Early Detection, Prevention, Diagnosis and Treatment of Diseases of the Pancreas.

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).

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

- Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Validation of glycoprotein panel as a pancreatic cancer biomarker

Outcome Description:

To create a set of cases and controls to validate a novel glycoprotein panel for non-invasive or early detection of pancreatic cancer.

Outcome Time Frame:

5 years

Safety Issue:



United States: Federal Government

Study ID:




Start Date:

April 2011

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • Chronic Pancreatitis
  • Type II Diabetes
  • Pancreatic Cysts
  • Healthy Control
  • Pancreatic Cancer
  • Chronic Pancreatitis
  • Diseases of the pancreas
  • Diabetes Mellitus, Type 2
  • Pancreatic Cyst
  • Pancreatic Diseases
  • Pancreatic Neoplasms
  • Pancreatitis
  • Pancreatitis, Chronic



Univerisity of MichiganAnn Arbor, Michigan  48109