Contact Allergies to Dental Metal as a Possible Risk Factor for Oral Cancer - Full Text View

Sponsors and Collaborators:	Mayo Clinic Scottsdale National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00693550

Purpose

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.

Condition	Intervention
Head and Neck Cancer	Procedure: evaluation of cancer risk factors Procedure: informational intervention Procedure: observation

MedlinePlus related topics: Allergy Cancer Head and Neck Cancer Oral Cancer

U.S. FDA Resources

Study Type:	Observational
Official Title:	Oral Metal Contact Allergy: A Cause of Oral Squamous Cell Carcinoma?

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Relationship between intraoral metal contact allergy and epithelial carcinogenesis [ Designated as safety issue: No ]
Prevalence of metal contact allergy comparison to study control data [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	August 2000
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693550

Locations

United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic Scottsdale

National Cancer Institute (NCI)

Investigators

Study Chair:	James A. Yiannias, MD	Mayo Clinic Scottsdale
Investigator:	Rokea el-Azhary, MD	Mayo Clinic

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000589036, MAYO-49700
Study First Received:	June 6, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00693550
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

lip and oral cavity squamous cell carcinoma
oropharyngeal squamous cell carcinoma

Study placed in the following topic categories:

Squamous cell carcinoma
Mouth Neoplasms
Lip and oral cavity cancer
Carcinoma
Epidermoid carcinoma
Hypersensitivity
Oral squamous cell carcinoma

Head and Neck Neoplasms
Oral cancer
Carcinoma, squamous cell
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009