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NCT00693550 Clinical Trial

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

Head and Neck Cancer Clinical Trial

Official title:
Oral Metal Contact Allergy: A Cause of Oral Squamous Cell Carcinoma?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00693550
Other study ID # 497-00
Secondary ID P30CA015083CDR00
Status Completed
Phase N/A
First received June 6, 2008
Last updated June 6, 2011
Start date August 2000
Est. completion date January 2009

Study information
Verified date June 2011
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 115
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Relationship between intraoral metal contact allergy and epithelial carcinogenesis one year No
Primary Prevalence of metal contact allergy comparison to study control data one year No
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