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Pancreatic Cancer Serum and DNA Repository
This study is currently recruiting participants.
Verified by Pancreatic Cancer Research Team, March 2006
First Received: February 22, 2006   Last Updated: March 28, 2006   History of Changes
Sponsored by: Pancreatic Cancer Research Team
Information provided by: Pancreatic Cancer Research Team
ClinicalTrials.gov Identifier: NCT00296114
  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:

  • 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.

Condition Intervention
Pancreas Cancer
Procedure: To collect serum and DNA samples from subjects

MedlinePlus related topics: Cancer Pancreatic Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study
Official Title: Pancreatic Cancer Serum and DNA Repository

Further study details as provided by Pancreatic Cancer Research Team:

Estimated Enrollment: 3500
Study Start Date: February 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296114

Contacts
Contact: Cindy Lentz 602 358 8312 clentz@tgen.org
Contact: Amy Stoll, MS 602 358 8319 astoll@tgen.org

Locations
United States, Arizona
Scottsdale Healthcare Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Elizabeth Lewis     480-657-1230     elewis@shc.org    
Contact: Sharon Fleck     480 657-1230     sfleck@shc.org    
Principal Investigator: Daniel D Von Hoff, MD            
Principal Investigator: Mitesh Borad, MD            
University of Arizona/Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Lora Macias     520-626-7725     lmacias@azcc.arizona.edu    
Principal Investigator: Tomislav Dragovich, MD, PhD            
Principal Investigator: Michael Demeure, MD, FACS            
United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90024-6970
Contact: Allida Beckhman         isacoffinsurance@earthlink.net    
Principal Investigator: William Isacoff, MD            
United States, Illinois
RUSH University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Alan Larson     312-942-5687     alan_larson@rush.edu    
Principal Investigator: Jules Harris, MD            
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Colleen Redlinger, BA     410-283-2150     credlin1@jhmi.edu    
Principal Investigator: Daniel Laheru, MD            
Principal Investigator: Manuel Hidalgo, MD, PhD            
Principal Investigator: Wells Messersmith, MD            
United States, Minnesota
Abbott Northwestern Hospital/Virginia Piper Cancer Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Stacy Pearson     612-863-5655     stacy.pearson@allina.com    
Principal Investigator: Timothy P Sielaff, MD, PhD            
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Valerie Parks     505-272-0898     vparks@salud.unm.edu    
Principal Investigator: Glenroy Heywood, MD            
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Emily Burkett     615-329-7355     emily.burchett@screarch.net    
Principal Investigator: Howard "Skip" Burris, MD            
United States, Texas
South Texas Oncology and Hematology Recruiting
San Antonio, Texas, United States, 78229
Contact: Dolly Fischer     210-616-7978     ifischer@ctrc.net    
Principal Investigator: Lon Smith, MD            
Spain
University Hospital (12 De Octubre) Recruiting
Madrid, Spain
Contact: Sofia Perea, PharmD, PHD     +34915006069     sperea.hdoc@salud.madrid.org    
Principal Investigator: Carlos Gomez-Martin, MD            
Sponsors and Collaborators
Pancreatic Cancer Research Team
Investigators
Study Chair: Manuel Hidalgo, MD, PhD Johns Hopkins University
  More Information

No publications provided

Study ID Numbers: PCRT 03 001
Study First Received: February 22, 2006
Last Updated: March 28, 2006
ClinicalTrials.gov Identifier: NCT00296114     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Pancreatic Cancer Research Team:
Cancer
Pancreas

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Pancrelipase
Endocrine Gland Neoplasms

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

ClinicalTrials.gov processed this record on May 06, 2009