Pancreatic CancerNCT00489671
Urine Cadmium Levels in Predicting Pancreatic Cancer Risk in Patients With Chronic Pancreatitis
An observational study of Pancreatic Cancer and Precancerous Condition, run by Wake Forest University Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Pancreatic Cancer, Precancerous Condition
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: chronic pancreatitis
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
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatic Cancer, Precancerous Condition
- Keywords
- pancreatic cancer, precancerous condition
- Medical subject headings
- Pancreatic Neoplasms, Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pre cancerous condition (pancreatitis) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure to cadmium, as measured by questionnaire data on dietary, occupational, and recreational exposure to cadmium, and by measurements of cadmium in urine
Measured: day 1
Risk of pancreatic cancer as determined by urine cadmium levels
Measured: day 1
Secondary outcomes (2)
Predictive value of urinary cadmium on development of pancreatic cancer
Measured: day 1
Predictive value of urinary cadmium alone, CA 19-9 alone, and both tests together on development of pancreatic cancer
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startJun 2003
- Primary completionOct 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gary G. Schwartz, MD, PhD, MPH, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489671
- Sponsor's protocol ID
- CDR0000550074
- Other IDs
- CCCWFU-98503, CCCWFU-BG03-223
- Status last verified
- Oct 2015
- First submitted
- 20 Jun 2007
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Diagnosis Between Pancreatic Cancer and Chronic Pancreatitis: Value of the Detection of Urinary Cadmium
- ClinicalTrials.gov ID
- NCT00489671
- Acronym / sponsor ID
- CDR0000550074
- Conditions
- Pancreatic Cancer, Precancerous Condition
- Keywords
- pancreatic cancer, precancerous condition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 21 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pre cancerous condition (pancreatitis) | – | – |
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- chronic pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Risk of pancreatic cancer as determined by urine cadmium levels
Time frame: day 1
2 secondary outcomes
Predictive value of urinary cadmium on development of pancreatic cancer
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary G. Schwartz, MD, PhD, MPH study chair
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Precancerous Condition, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.