Urine Cadmium Levels in Predicting Pancreatic Cancer Risk in Patients With Chronic Pancreatitis
RATIONALE: Measuring cadmium levels in urine samples from patients with chronic pancreatitis may help doctors predict which patients may develop pancreatic cancer. It may also help the study of cancer in the future.
PURPOSE: This clinical trial is studying urine cadmium levels in predicting pancreatic cancer risk in patients with chronic pancreatitis.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Differential Diagnosis Between Pancreatic Cancer and Chronic Pancreatitis: Value of the Detection of Urinary Cadmium|
- Exposure to cadmium, as measured by questionnaire data on dietary, occupational, and recreational exposure to cadmium, and by measurements of cadmium in urine [ Time Frame: day 1 ]
- Risk of pancreatic cancer as determined by urine cadmium levels [ Time Frame: day 1 ]
- Predictive value of urinary cadmium on development of pancreatic cancer [ Time Frame: day 1 ]
- Predictive value of urinary cadmium alone, CA 19-9 alone, and both tests together on development of pancreatic cancer [ Time Frame: day 1 ]
|Study Start Date:||June 2003|
|Study Completion Date:||August 2007|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
|pre cancerous condition (pancreatitis)|
- Obtain urine samples and questionnaire data on cadmium exposure in patients with chronic pancreatitis.
- Analyze these data to determine risk of pancreatic cancer using urine cadmium levels.
- Analyze these data in conjunction with data on serum CA 19-9, to determine whether urinary cadmium has clinical utility in predicting pancreatic cancer.
- Determine the sensitivity, specificity, and positive and negative predictive values for the cadmium test alone, CA 19-9 alone, and both tests together.
OUTLINE: This is a pilot study.
Patients complete a questionnaire over approximately 20 minutes on lifetime exposure to cadmium, including dietary, occupational, and recreational exposure, smoking history, and residence. Patients also provide a urine sample that is analyzed by atomic absorption spectrophotometry. Serum CA 19-9 levels are obtained from medical record if available.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489671
|Study Chair:||Gary G. Schwartz, MD, PhD, MPH||Wake Forest University Health Sciences|