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

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ClinicalTrials.gov Identifier: NCT00489671
Recruitment Status : Completed
First Posted : June 21, 2007
Last Update Posted : January 19, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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
Pancreatic Cancer Precancerous Condition

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 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 : June 2003
Actual Primary Completion Date : October 2006
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Cadmium

Group/Cohort
pre cancerous condition (pancreatitis)



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489671


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

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00489671     History of Changes
Other Study ID Numbers: CDR0000550074
CCCWFU-98503
CCCWFU-BG03-223
First Posted: June 21, 2007    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: October 2015

Keywords provided by Wake Forest University Health Sciences:
pancreatic cancer
precancerous condition

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Pancreatitis
Pancreatitis, Chronic
Precancerous Conditions
Digestive System Diseases
Endocrine System Diseases