Trial record 12 of 779 for:    Open Studies | "Pancreatic Diseases"

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
  Purpose

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 ] [ 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.


Estimated Enrollment: 5000
Study Start Date: April 2011
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Disease vs healthy 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392027

Locations
United States, Michigan
Univerisity of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Missy Tuck, M.S.    734-763-1141    mtuck@umich.edu   
Principal Investigator: Michelle A Anderson, M.D., M.P.H         
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Missy Tuck, Project manager, University of Michigan
ClinicalTrials.gov Identifier: NCT01392027     History of Changes
Other Study ID Numbers: P50-CA13081001A2
Study First Received: July 6, 2011
Last Updated: May 15, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Pancreatic Diseases
Diabetes Mellitus, Type 2
Pancreatic Cyst
Pancreatic Neoplasms
Pancreatitis
Pancreatitis, Chronic
Cysts
Diabetes Mellitus
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 22, 2014