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

NCT ID: NCT00489671

Last Updated: 2017-01-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-06-30

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Cancer Precancerous Condition

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

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
Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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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