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

January 17, 2017 updated by: Wake Forest University Health Sciences

Differential Diagnosis Between Pancreatic Cancer and Chronic Pancreatitis: Value of the Detection of Urinary Cadmium

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

32

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

chronic pancreatitis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
pre cancerous condition (pancreatitis)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: day 1
day 1
Risk of pancreatic cancer as determined by urine cadmium levels
Time Frame: day 1
day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Predictive value of urinary cadmium on development of pancreatic cancer
Time Frame: day 1
day 1
Predictive value of urinary cadmium alone, CA 19-9 alone, and both tests together on development of pancreatic cancer
Time Frame: day 1
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Gary G. Schwartz, MD, PhD, MPH, Wake Forest University Health Sciences

Study record dates

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 Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria

June 20, 2007

First Posted (Estimate)

June 21, 2007

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000550074
  • CCCWFU-98503
  • CCCWFU-BG03-223

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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