Pancreatic Cancer Serum and DNA Repository

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pancreatic Cancer Research Team
ClinicalTrials.gov Identifier:
NCT00296114
First received: February 22, 2006
Last updated: April 29, 2013
Last verified: December 2011
  Purpose

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:


Condition Intervention
Pancreas Cancer
Procedure: Serum and DNA Samples

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pancreatic Cancer Serum and DNA Repository

Resource links provided by NLM:


Further study details as provided by Pancreatic Cancer Research Team:

Biospecimen Retention:   Samples With DNA

Whole Blood and Serum Samples


Enrollment: 690
Study Start Date: February 2004
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Serum and DNA Samples
    To collect serum and DNA samples from subjects
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  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: NCT00296114

Locations
United States, Arizona
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85259
University of Arizona/Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
UCLA Medical Center
Los Angeles, California, United States, 90024-6970
United States, Illinois
RUSH University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Minnesota
Abbott Northwestern Hospital/Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
South Texas Oncology and Hematology
San Antonio, Texas, United States, 78229
Spain
University Hospital (12 De Octubre)
Madrid, Spain
Sponsors and Collaborators
Pancreatic Cancer Research Team
Investigators
Study Chair: Manuel Hidalgo, MD, PhD Hospital Universitario Sanchinarro, Madrid, Spain
  More Information

Additional Information:
No publications provided

Responsible Party: Pancreatic Cancer Research Team
ClinicalTrials.gov Identifier: NCT00296114     History of Changes
Obsolete Identifiers: NCT00250107
Other Study ID Numbers: PCRT 03 001
Study First Received: February 22, 2006
Last Updated: April 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pancreatic Cancer Research Team:
Cancer
Pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 28, 2014