Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Urine Cadmium Levels in Predicting Pancreatic Cancer Risk in Patients With Chronic Pancreatitis
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Biomarker/Laboratory analysis, Natural history/Epidemiology | Closed | Not specified | NCI | CCCWFU-98503 CCCWFU-BG03-223, CCCWFU 98503, NCT00489671 |
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.
Entry Criteria
Disease Characteristics:
- Clinical diagnosis of chronic pancreatitis
- Being seen in the Department of Gastroenterology at Wake Forest University Baptist Medical Center
Prior/Concurrent Therapy:
- Not specified
Patient Characteristics:
- No type II diabetes
- Able to understand and respond to questionnaire
- Able to provide urine specimen
- Speaks English
Expected Enrollment
30Outcomes
Primary Outcome(s)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
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
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.
Trial Lead Organizations
Wake Forest University Comprehensive Cancer Center
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| Gary Schwartz, MD, PhD, MPH, Protocol chair | |
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| Registry Information | ||
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| Official Title | Differential Diagnosis Between Pancreatic Cancer and Chronic Pancreatitis: Value of the Detection of Urinary Cadmium | |
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| Trial Start Date | 2003-06-23 | |
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| Registered in ClinicalTrials.gov | NCT00489671 | |
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| Date Submitted to PDQ | 2007-05-10 | |
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| Information Last Verified | 2007-07-12 | |
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| NCI Grant/Contract Number | CA12197 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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