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Sponsors and Collaborators: |
University of Nebraska National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00661882 |
RATIONALE: Gathering information about patients with cancer may help doctors learn more about the disease and plan early diagnosis and treatment.
PURPOSE: This clinical trial is studying computer tools for improving early diagnosis and treatment in patients with pancreatic cancer, are at risk for pancreatic cancer, or have a non-cancerous pancreatic disorder.
Condition | Intervention |
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Pancreatic Cancer |
Other: medical chart review Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: biopsy |
Study Type: | Observational |
Official Title: | 1) Development of the Pancreatic Cancer Collaborative Registry and Risk Assessment Models; 2) Pancreatic Cancer Pre-Validation Reference Set for Serum/Plasma Biomarkers; 3) Effects of Tobacco and Alcohol on Pancreatic Cancer; 4) Enhancing the Biomedical Computing Platform for Pancreatic Cancer Research |
Estimated Enrollment: | 240 |
Study Start Date: | February 2003 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients undergo blood and pancreatic tissue collection. Normal, tumor, and/or metastatic pancreatic cancer tissue, and/or paraffin-embedded tissue from prior surgery or biopsy are obtained.
Patients provide or complete personal information about themselves, their medical history, their diet and lifestyle habits, any past or current environmental exposures, and re-create their family tree for any cancers that have occurred in any of their family members. Clinical data is collected annually.
Control participants provide blood samples and complete questionnaires at baseline. Clinical data is collected annually.
PROJECTED ACCRUAL: A total of 60 patients per group (i.e., cancer cases, healthy controls, acute biliary obstruction cases, and chronic pancreatitis cases) for a total of 240 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients must meet 1 of the following criteria:
Histologically confirmed adenocarcinoma of the pancreas
Resectable stage I-IIA disease or stage IIB or higher disease
Control participants must meet 1 of the following criteria:
Chronic pancreatitis OR history of exocrine insufficiency meeting the following criteria:
At least 2 of the following criteria are met (unless patient has a history of pancreatic exocrine insufficiency in which case only 1 criterion must be met):
Acute biliary obstruction (stones) including jaundice of benign etiology meeting the following criteria:
Healthy control meeting the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Nebraska | |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Recruiting |
Omaha, Nebraska, United States, 68198-6805 | |
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ 800-999-5465 |
Principal Investigator: | Simon Sherman, PhD | University of Nebraska |
Study ID Numbers: | CDR0000582361, UNMC-40502 |
Study First Received: | April 18, 2008 |
Last Updated: | June 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00661882 History of Changes |
Health Authority: | Unspecified |
adenocarcinoma of the pancreas recurrent pancreatic cancer stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Healthy Pancrelipase Recurrence Digestive System Diseases |
Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Adenocarcinoma Endocrine Gland Neoplasms Ethanol |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases Endocrine Gland Neoplasms |