Status:
COMPLETED
Pancreatic Cancer Collaborative Registry
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
19-100 years
Brief Summary
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 too...
Detailed Description
OBJECTIVES: * Develop Integrated Biomedical Computing Tools (IBCT) for the better understanding and treatment of pancreatic cancer by using the power of computer and informatics sciences. * Continue ...
Eligibility Criteria
Inclusion
- Patients Participants
- Must meet 1 of the following criteria:
- Histologically confirmed adenocarcinoma of the pancreas
- Resectable stage I-IIA disease or stage IIB or higher disease Must have undergone complete surgical resection of the tumor with curative intent
- Pancreatic mass (solid) that is less than 4 cm as determined by any conventional imaging (MRI, EUS, or CT scan)
- No evidence of extension of the mass beyond the pancreas including vascular invasion or invasion into surrounding organs, with the exception of the bile duct
- No imaging evidence of metastatic disease or lymphadenopathy (lymph nodes greater than 1 cm and/or appearance suspicious for an advanced lesion by imaging criteria)
- Has a family history of pancreatic cancer and is considered to be an at-risk individual for the disease (i.e., member of a family with 2 or more individuals with pancreatic cancer)
- Patients Participants
Exclusion
- No prior malignancy, except nonmelanoma skin cancer, for 10 years
- No prior preoperative chemoradiotherapy (neoadjuvant)
- Control participants Inclusion Criteria:
- Must meet 1 of the following criteria:
- Chronic pancreatitis OR history of exocrine insufficiency meeting the following criteria:
- o 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): Abdominal ultrasound that is consistent with chronic pancreatitis by standard radiological criteria (i.e., echogenic foci in the parenchyma, large or small cavities, calcifications, or dilated pancreatic duct) Abdominal CT scan consistent with chronic pancreatitis by standard radiological criteria (i.e., calcifications, dilated pancreatic duct, irregular contour of the gland, or cystic lesions) Endoscopic retrograde cholangiopancreatography exam consistent with chronic pancreatitis by standard radiological criteria (i.e., dilated tortuous main pancreatic duct with irregular secondary branches or intraductal calculi) Endoscopic ultrasound consistent with chronic pancreatitis by standard radiological criteria (i.e., echogenic foci, focal regions of decreased echogenicity, or pancreatic ductal changes)Pancreatic calcifications identified on plain film of the abdomen
- Must have an imaging study of the pancreas within 3 months of study enrollment that does not suggest a pancreatic mass
- Stable clinical history over the past year with no suspicion for cancer due to weight loss, jaundice, or change in abdominal symptoms
- Acute biliary obstruction (stones) including jaundice of benign etiology meeting the following criteria:
- Elevation of serum bilirubin level greater than 2.0 mg/dL
- Dilated extrahepatic biliary systems demonstrated on US, MRI, or CT scan
- Blood sample available within 72 hours of admission and prior to any corrective intervention
- Biliary obstruction must be of benign etiology such as common bile duct stone or benign biliary stricture
- Must have complete imaging study performed of the pancreas that does not suggest a pancreatic cancer (i.e., discrete mass lesion)
- Age, race, and sex-matched to qualified pancreatic cancer cases
- Control Participants
Key Trial Info
Start Date :
February 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 9 2013
Estimated Enrollment :
379 Patients enrolled
Trial Details
Trial ID
NCT00661882
Start Date
February 1 2003
End Date
September 9 2013
Last Update
September 6 2023
Active Locations (1)
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1
Eppley Cancer Center, University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805