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
  Purpose

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.


Condition
Pancreatic Cancer
Precancerous Condition

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Differential Diagnosis Between Pancreatic Cancer and Chronic Pancreatitis: Value of the Detection of Urinary Cadmium

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: June 2003
Study Completion Date: August 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
pre cancerous condition (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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

chronic pancreatitis

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489671

Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: Gary G. Schwartz, MD, PhD, MPH Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00489671     History of Changes
Other Study ID Numbers: CDR0000550074, CCCWFU-98503, CCCWFU-BG03-223
Study First Received: June 20, 2007
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
pancreatic cancer
precancerous condition

Additional relevant MeSH terms:
Pancreatic Neoplasms
Pancreatitis
Precancerous Conditions
Pancreatitis, Chronic
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 20, 2014