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

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ClinicalTrials.gov Identifier: NCT00693550
Recruitment Status : Completed
First Posted : June 9, 2008
Last Update Posted : June 8, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

June 6, 2008
June 9, 2008
June 8, 2011
August 2000
January 2009   (Final data collection date for primary outcome measure)
  • Relationship between intraoral metal contact allergy and epithelial carcinogenesis [ Time Frame: one year ]
  • Prevalence of metal contact allergy comparison to study control data [ Time Frame: one year ]
  • Relationship between intraoral metal contact allergy and epithelial carcinogenesis
  • Prevalence of metal contact allergy comparison to study control data
Complete list of historical versions of study NCT00693550 on ClinicalTrials.gov Archive Site
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
otorhinolaryngology departments of Mayo Clinic Rochester and Mayo Clinic Arizona
Head and Neck Cancer
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
200
January 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00693550
497-00
P30CA015083 ( U.S. NIH Grant/Contract )
CDR0000589036 ( Other Identifier: Mayo Clinic )
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James A. Yiannias M.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: James A. Yiannias, MD Mayo Clinic
Mayo Clinic
June 2011