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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Missy Tuck, University of Michigan Identifier:
First received: July 6, 2011
Last updated: November 7, 2016
Last verified: November 2016

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 Intervention
Pancreatic Cancer
Chronic Pancreatitis
Type II Diabetes
Pancreatic Cysts
Healthy Control
Procedure: Blood Draw

Study Type: Interventional
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.

Resource links provided by NLM:

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 5000
Study Start Date: April 2011
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Blood Draw
    Blood draw for research specimens only
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).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01392027

United States, Michigan
Univerisity of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
  More Information

Responsible Party: Missy Tuck, Project manager, University of Michigan Identifier: NCT01392027     History of Changes
Other Study ID Numbers: P50-CA13081001A2
Study First Received: July 6, 2011
Last Updated: November 7, 2016

Keywords provided by University of Michigan:
Pancreatic Cancer
Chronic Pancreatitis
Diseases of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Pancreatitis, Chronic
Diabetes Mellitus, Type 2
Pancreatic Cyst
Pancreatic Diseases
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Gastrointestinal Agents processed this record on May 25, 2017