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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00489671

Enrollment

Registered

2007-06-21

Start date

2003-06-30

Completion date

2007-08-31

Last updated

2017-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer, Precancerous Condition

Keywords

pancreatic cancer, precancerous condition

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 120 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	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

Measure	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

Outcome results