Clinical trial NCT01392027: Biospecimens for Identification of Diseases of the Pancreas.
Official title: Biospecimens for the Early Detection, Prevention, Diagnosis and Treatment of Diseases of the Pancreas.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Chronic Pancreatitis
Type II Diabetes
Pancreatic Cysts
Healthy Control
Keywords: Pancreatic Cancer
Chronic Pancreatitis
Diseases of the pancreas
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 712
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

Eligibility 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

Primary outcomes:
measure: Validation of glycoprotein panel as a pancreatic cancer biomarker
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Univerisity of Michigan
state: Michigan
Study officials:
References: