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

Completed

• Conditions: Pancreatic Cancer; Precancerous Condition

• Registration Number: NCT00489671
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2006-10
• Study First Submitted: 2007-06-20
• Study First Submitted QC: 2007-06-20
• Study First Posted: 2007-06-21
• Study Completion: 2007-08
• Status Verified: 2015-10
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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