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

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 Type: Observational

Study Design: N/A

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.

Intervention(s) in this Clinical Trial

• Procedure: evaluation of cancer risk factors
• Procedure: laboratory biomarker analysis
• Procedure: medical chart review
• Procedure: questionnaire administration
• Procedure: spectroscopy
• Procedure: study of high risk factors

Primary Measures

• Exposure to cadmium, as measured by questionnaire data on dietary, occupational, and recreational exposure to cadmium, and by measurements of cadmium in urine
• Risk of pancreatic cancer as determined by urine cadmium levels

Secondary Measures

• Predictive value of urinary cadmium on development of pancreatic cancer
• Predictive value of urinary cadmium alone, CA 19-9 alone, and both tests together on development of pancreatic cancer

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wake Forest University

Overall Clinical Trial Officials and Contacts

Gary G. Schwartz, MD, PhD, MPH Study Chair Wake Forest University  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00489671

Study ID Number: CDR0000550074

ClinicalTrials.gov Identifier: NCT00489671

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database