Clinical trial NCT00489671: Urine Cadmium Levels in Predicting Pancreatic Cancer Risk in Patients With Chronic Pancreatitis
Official title: Differential Diagnosis Between Pancreatic Cancer and Chronic Pancreatitis: Value of the Detection of Urinary Cadmium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Precancerous Condition
Keywords: pancreatic cancer
precancerous condition
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-06-21
Enrollment: 32
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic pancreatitis

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Exposure to cadmium, as measured by questionnaire data on dietary, occupational, and recreational exposure to cadmium, and by measurements of cadmium in urine
timeFrame: day 1
measure: Risk of pancreatic cancer as determined by urine cadmium levels
timeFrame: day 1
Secondary outcomes:
measure: Predictive value of urinary cadmium on development of pancreatic cancer
timeFrame: day 1
measure: Predictive value of urinary cadmium alone, CA 19-9 alone, and both tests together on development of pancreatic cancer
timeFrame: day 1
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Gary G. Schwartz, MD, PhD, MPH
role: STUDY_CHAIR
References: