Pancreatic Cancer Serum and DNA Repository

Completed

• Conditions: Pancreas Cancer

• Registration Number: NCT00296114
• Lead Sponsor: Pancreatic Cancer Research Team

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:

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 Timeline

• Study Start: 2004-02
• Study First Submitted: 2006-02-22
• Study First Submitted QC: 2006-02-22
• Study First Posted: 2006-02-24
• Status Verified: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2013-04-29
• Last Update Posted: 2013-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 690

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (10)

University of Arizona/Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Scottsdale Healthcare; 🇺🇸 Scottsdale, Arizona, United States

Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Abbott Northwestern Hospital/Virginia Piper Cancer Institute; 🇺🇸 Minneapolis, Minnesota, United States

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

University Hospital (12 De Octubre); 🇪🇸 Madrid, Spain

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

South Texas Oncology and Hematology; 🇺🇸 San Antonio, Texas, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

RUSH University Medical Center; 🇺🇸 Chicago, Illinois, United States