Urine Cadmium Levels in Predicting Pancreatic Cancer Risk in Patients With Chronic Pancreatitis
This study has been completed.
Sponsor:
Comprehensive Cancer Center of Wake Forest University
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
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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:
Genetics Home Reference related topics:
hereditary pancreatitis
Drug Information available for:
Cadmium
U.S. FDA Resources
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 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 May 16, 2013