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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00489671
First received: June 20, 2007
Last updated: July 12, 2012
Last verified: July 2012

June 20, 2007
July 12, 2012
June 2003
October 2006   (final data collection date for primary outcome measure)
  • Exposure to cadmium, as measured by questionnaire data on dietary, occupational, and recreational exposure to cadmium, and by measurements of cadmium in urine [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Risk of pancreatic cancer as determined by urine cadmium levels [ Time Frame: day 1 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00489671 on ClinicalTrials.gov Archive Site
  • Predictive value of urinary cadmium on development of pancreatic cancer [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Predictive value of urinary cadmium alone, CA 19-9 alone, and both tests together on development of pancreatic cancer [ Time Frame: day 1 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

chronic pancreatitis

  • Pancreatic Cancer
  • Precancerous Condition
Not Provided
pre cancerous condition (pancreatitis)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
August 2007
October 2006   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00489671
CDR0000550074, CCCWFU-98503, CCCWFU-BG03-223
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Study Chair: Gary G. Schwartz, MD, PhD, MPH Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP