Contact Allergies to Dental Metal as a Possible Risk Factor for Oral Cancer

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

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-08-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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metal patch tests

Twenty - seven (27) metal patch tests will be applied to the patient's back and left in place for 3 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes