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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489671
• Other study ID #: CDR0000550074
• Secondary ID: CCCWFU-98503CCCW
• Status: Completed
• Phase: N/A
• First received: June 20, 2007
• Last updated: January 17, 2017
• Start date: June 2003
• Est. completion date: August 2007

Study information

• Verified date: October 2015
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Pancreatitis
• Pancreatitis, Chronic
• Precancerous Condition
• Precancerous Conditions

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Risk of pancreatic cancer as determined by urine cadmium levels		day 1
Secondary	Predictive value of urinary cadmium on development of pancreatic cancer		day 1
Secondary	Predictive value of urinary cadmium alone, CA 19-9 alone, and both tests together on development of pancreatic cancer		day 1