Clincosm LogoSign in Get a demo

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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT00489671
Collaborator
National Cancer Institute (NCI) (NIH)
32
Enrollment
50
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    32 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Differential Diagnosis Between Pancreatic Cancer and Chronic Pancreatitis: Value of the Detection of Urinary Cadmium
    Study Start Date :
    Jun 1, 2003
    Actual Primary Completion Date :
    Oct 1, 2006
    Actual Study Completion Date :
    Aug 1, 2007

    Arms and Interventions

    Arm Intervention/Treatment
    pre cancerous condition (pancreatitis)

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. Risk of pancreatic cancer as determined by urine cadmium levels [day 1]

    Secondary Outcome Measures

    1. Predictive value of urinary cadmium on development of pancreatic cancer [day 1]

    2. Predictive value of urinary cadmium alone, CA 19-9 alone, and both tests together on development of pancreatic cancer [day 1]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Gary G. Schwartz, MD, PhD, MPH, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT00489671
    Other Study ID Numbers:
    • CDR0000550074
    • CCCWFU-98503
    • CCCWFU-BG03-223
    First Posted:
    Jun 21, 2007
    Last Update Posted:
    Jan 19, 2017
    Last Verified:
    Oct 1, 2015
    Keywords provided by Wake Forest University Health Sciences
    pancreatic cancer
    precancerous condition
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Precancerous Conditions
    Pancreatitis
    Pancreatitis, Chronic

    Study Results

    No Results Posted as of Jan 19, 2017