Pancreatic Cancer Serum and DNA Repository
1 other identifier
observational
690
2 countries
10
Brief Summary
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:
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2004
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 22, 2006
CompletedFirst Posted
Study publicly available on registry
February 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMay 1, 2013
December 1, 2011
7.8 years
February 22, 2006
April 29, 2013
Conditions
Keywords
Interventions
To collect serum and DNA samples from subjects
Eligibility Criteria
Samples are collected on: Pancreatic Cancer, Liver Disease, Pancreatitis, Healthy and Healthy at Risk Subjects.
You may qualify if:
- Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
- Criteria
- At the time of subject registration, CRAB will verify the institution's IRB date to ensure that the subject can be enrolled.
- Potential study participants must meet the eligibility criteria found in Section 12.0 (Eligibility Checklist). Candidates will fall into one of four groups:
- Pancreatic cancer patients;
- Pancreatic and Liver Disease patients;
- 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
- 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:
- 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
- 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
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Scottsdale Healthcare
Scottsdale, Arizona, 85259, United States
University of Arizona/Arizona Cancer Center
Tucson, Arizona, 85724, United States
UCLA Medical Center
Los Angeles, California, 90024-6970, United States
RUSH University Medical Center
Chicago, Illinois, 60612, United States
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins
Baltimore, Maryland, 21231, United States
Abbott Northwestern Hospital/Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
South Texas Oncology and Hematology
San Antonio, Texas, 78229, United States
University Hospital (12 De Octubre)
Madrid, Spain
Related Links
Biospecimen
Whole Blood and Serum Samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Manuel Hidalgo, MD, PhD
Hospital Universitario Sanchinarro, Madrid, Spain
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2006
First Posted
February 24, 2006
Study Start
February 1, 2004
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
May 1, 2013
Record last verified: 2011-12