- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2003-06
2006-10
2007-08
32
NCT00489671
Wake Forest University Health Sciences
Wake Forest University Health Sciences
OBSERVATIONAL
Urine Cadmium Levels in Predicting Pancreatic Cancer Risk in Patients With Chronic Pancreatitis
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2007-06-20 | N/A | 2017-01-17 |
2007-06-20 | N/A | 2017-01-19 |
2007-06-21 | N/A | 2015-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : pre cancerous condition (pancreatitis) |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | |
| Risk of pancreatic cancer as determined by urine cadmium levels | day 1 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Predictive value of urinary cadmium on development of pancreatic cancer | day 1 | |
| Predictive value of urinary cadmium alone, CA 19-9 alone, and both tests together on development of pancreatic cancer | day 1 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
