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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 15, 2014
Last verified: May 2014

July 6, 2011
May 15, 2014
April 2011
September 2016   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01392027 on ClinicalTrials.gov Archive Site
Not Provided
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Biospecimens for Identification of Diseases of the Pancreas.
Biospecimens for the Early Detection, Prevention, Diagnosis and Treatment of Diseases of the Pancreas.

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.

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).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Pancreatic Cancer
  • Chronic Pancreatitis
  • Type II Diabetes
  • Pancreatic Cysts
  • Healthy Control
Procedure: Blood Draw
Blood draw for research specimens only
No Intervention: Disease vs healthy
Intervention: Procedure: Blood Draw
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
Not Provided
September 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
United States
 
NCT01392027
P50-CA13081001A2
Yes
Missy Tuck, University of Michigan
University of Michigan
Not Provided
Not Provided
University of Michigan
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP