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Pilot Study of Urine Cadmium Levels in Determining Pancreatic Cancer Risk in Patients With Chronic Pancreatitis

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

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

Outcomes

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

Secondary Outcome(s)

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 Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

Gary Schwartz, MD, PhD, MPH, Protocol chair
Ph: 336-716-7446; 800-446-2255
Email: gschwart@wfubmc.edu

Registry Information

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

Trial Start Date		2003-06-23

Registered in ClinicalTrials.gov		NCT00489671

Date Submitted to PDQ		2007-05-10

Information Last Verified		2007-07-12

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.