Urine Cadmium Levels in Predicting Pancreatic Cancer Risk in Patients With Chronic Pancreatitis

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary 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. Secondary 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.

Official Title
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Differential Diagnosis Between Pancreatic Cancer and Chronic Pancreatitis: Value of the Detection of Urinary Cadmium

Conditions
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Pancreatic Cancer, Precancerous Condition

Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Clinical diagnosis of chronic pancreatitis Being seen in the Department of Gastroenterology at Wake Forest University Baptist Medical Center PATIENT CHARACTERISTICS: No type II diabetes Able to understand and respond to questionnaire Able to provide urine specimen Speaks English PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pre cancerous condition (pancreatitis)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure to cadmium, as measured by questionnaire data on dietary, occupational, and recreational exposure to cadmium, and by measurements of cadmium in urine |  | day 1 | 
| Risk of pancreatic cancer as determined by urine cadmium levels |  | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of urinary cadmium on development of pancreatic cancer |  | day 1 | 
| Predictive value of urinary cadmium alone, CA 19-9 alone, and both tests together on development of pancreatic cancer |  | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic cancer, precancerous condition