- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00693550
Contact Allergies to Dental Metal as a Possible Risk Factor for Oral Cancer
Oral Metal Contact Allergy: A Cause of Oral Squamous Cell Carcinoma?
RATIONALE: Gathering information about allergies to metals may help doctors learn whether having an allergy to metal used in dental work increases the risk of developing oral cancer.
PURPOSE: This clinical trial is studying contact allergies to dental metal as a possible risk factor for oral cancer.
Study Overview
Detailed Description
OBJECTIVES:
- Identify the relationship between intraoral metal contact allergy and epithelial carcinogenesis in patients with newly or previously diagnosed intraoral squamous cell carcinoma.
- Compare the prevalence of metal contact allergy in these patients with control data from other existing study populations.
OUTLINE: This is a multicenter study.
- Participants undergo metal patch testing using 27 metals* commonly used in dental repairs that are part of the Mayo metal series. Metal patches are applied to the patient's back for 3 days and the back is read on days 3 and 5. Relevant patient data obtained from their medical and dental history, physical exam, laboratory values and treatment are documented.
NOTE: *Healthy volunteers (control) undergo metal patch testing using 8 metals most commonly positive for contact allergens.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Newly or previously diagnosed oral squamous cell carcinoma
- Recruited from the otorhinolaryngology departments of Mayo Clinic Rochester and Mayo Clinic Arizona
Healthy volunteer (control)
- No history of intraoral squamous cell carcinoma
- Employed at Mayo Clinic Rochester or Mayo Clinic Arizona
PATIENT CHARACTERISTICS:
- No immunosuppression
- No other conditions that interfere with patch testing
PRIOR CONCURRENT THERAPY:
- Not specified
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relationship between intraoral metal contact allergy and epithelial carcinogenesis
Time Frame: one year
|
one year
|
Prevalence of metal contact allergy comparison to study control data
Time Frame: one year
|
one year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: James A. Yiannias, MD, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 497-00
- P30CA015083 (U.S. NIH Grant/Contract)
- CDR0000589036 (Other Identifier: Mayo Clinic)
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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