Urine Cadmium Levels in Predicting Pancreatic Cancer Risk in Patients With Chronic Pancreatitis
NCT ID: NCT00489671
Last Updated: 2017-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
32 participants
OBSERVATIONAL
2003-06-30
2007-08-31
Brief Summary
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PURPOSE: This clinical trial is studying urine cadmium levels in predicting pancreatic cancer risk in patients with chronic pancreatitis.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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pre cancerous condition (pancreatitis)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Gary G. Schwartz, MD, PhD, MPH
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Other Identifiers
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CCCWFU-98503
Identifier Type: -
Identifier Source: secondary_id
CCCWFU-BG03-223
Identifier Type: -
Identifier Source: secondary_id
CDR0000550074
Identifier Type: -
Identifier Source: org_study_id
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