Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489671
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2007-06-20
Brief Title:
Urine Cadmium Levels in Predicting Pancreatic Cancer Risk in Patients With Chronic Pancreatitis
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Differential Diagnosis Between Pancreatic Cancer and Chronic Pancreatitis Value of the Detection of Urinary Cadmium
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
PURPOSE This clinical trial is studying urine cadmium levels in predicting pancreatic cancer risk in patients with chronic 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCCWFU-BG03-223 | None | None | None |
| CCCWFU-98503 | None | None | None |