Pancreatic Cancer Serum and DNA Repository

To prospectively collect serum and DNA samples from subjects with pancreatic cancer, pancreatitis, liver disease, and from healthy and at-risk volunteers in order to identify novel biomarkers for early diagnosis, differential diagnosis, stage, natural history of the disease, response to treatment, and to identify novel targets for therapeutic interventions. In particular:

Study Overview

• Status: Completed
• Conditions: Pancreas Cancer
• Intervention / Treatment: Procedure: Serum and DNA Samples

Detailed Description

• To establish a central pancreatic cancer specimen repository to serve as a resource for current and future scientific studies.
• To utilize the PCRT clinical data base to perform clinicopathologic correlation with the results of those studies.
• To test new hypotheses as they emerge.

• Study Type: Observational
• Enrollment (Actual): 690

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • University Hospital (12 De Octubre)
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Scottsdale Healthcare
    • Tucson, Arizona, United States, 85724
      • University of Arizona/Arizona Cancer Center
  • California
    • Los Angeles, California, United States, 90024-6970
      • UCLA Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital/Virginia Piper Cancer Institute
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute
  • Texas
    • San Antonio, Texas, United States, 78229
      • South Texas Oncology And Hematology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Samples are collected on: Pancreatic Cancer, Liver Disease, Pancreatitis, Healthy and Healthy at Risk Subjects.

Description

Inclusion Criteria:

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

4.1 At the time of subject registration, CRAB will verify the institution's IRB date to ensure that the subject can be enrolled.

4.2 Potential study participants must meet the eligibility criteria found in Section 12.0 (Eligibility Checklist). Candidates will fall into one of four groups:

1. Pancreatic cancer patients;
2. Pancreatic and Liver Disease patients;
3. Healthy, At-Risk Volunteers (smoker, (defined as individuals who have smoked >= 100 cigarettes in their lifetime, and who currently smoke every day or some days [MMWR November 12, 2004, 53(44);1035-1037]), diabetic, and/or family history); and
4. Healthy Volunteers (no history of cancer). The Eligibility Checklist must be photocopied, completed and stored on site. Eligibility is confirmed during registration, by answering yes to the question, Have all eligibility criteria been met? on the Registration Form.

Eligibility Checklist:

1. Pancreatic Cancer Patient Criteria All subjects, regardless of gender and ethnicity are eligible for this study Pathological diagnosis of pancreatic malignant neoplasm Expected availability of clinical follow up data Eighteen years old or older All subjects must be informed of the investigational nature of this protocol Written, informed consent obtained in accordance with institutional and federal guidelines
2. Pancreatitis and Liver Disease Subject Criteria All subjects, regardless of gender and ethnicity are eligible for this study Pathological diagnosis of pancreatitis or liver disease Eighteen years old or older All subjects must be informed of the investigational nature of this protocol Written, informed consent obtained in accordance with institutional and federal guidelines
3. Healthy, At-Risk Volunteers All subjects, regardless of gender and ethnicity are eligible for this study Is a smoker, is diabetic AND/OR has a family history of pancreatic cancer Eighteen years old or older with no history of cancer All subjects must be informed of the investigational nature of this protocol Written, informed consent obtained in accordance with institutional and federal guidelines
4. Healthy Volunteers (no at-risk factors) All subjects, regardless of gender and ethnicity are eligible for this study Eighteen years old or older with no history of cancer All subjects must be informed of the investigational nature of this protocol Written, informed consent obtained in accordance with institutional and federal guidelines

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Pancreatic Cancer Research Team
• Investigators: Study Chair: Manuel Hidalgo, MD, PhD, Hospital Universitario Sanchinarro, Madrid, Spain

Publications and helpful links

Helpful Links

• Pancreatic Cancer Research Team - Public/Members

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 22, 2006
• First Submitted That Met QC Criteria: February 22, 2006
• First Posted (Estimate): February 24, 2006

Study Record Updates

• Last Update Posted (Estimate): May 1, 2013
• Last Update Submitted That Met QC Criteria: April 29, 2013
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Cancer; Pancreas
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: PCRT 03 001