Biospecimens for Identification of Diseases of the Pancreas.

NCT01392027 | Completed DMC

• 1 other identifier: P50-CA13081001A2
• Study Type: interventional
• Target: 712
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Chronic Pancreatitis; Type II Diabetes; Pancreatic Cysts; Healthy Control

Keywords

Pancreatic Cancer; Chronic Pancreatitis; Diseases of the pancreas

Outcome Measures

Primary Outcomes (1)

• Validation of glycoprotein panel as a pancreatic cancer biomarker

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

  5 years

Interventions

Blood Draw PROCEDURE

Blood draw for research specimens only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years of age or older
• Able to physically tolerate removal of 50 ml of blood
• Willing to sign informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Univerisity of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatitis, Chronic; Diabetes Mellitus, Type 2; Pancreatic Cyst; Pancreatic Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Endocrine System Diseases; Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Cysts

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 12, 2011
• Study Start: April 1, 2011
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11

Locations

US (1)