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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 6, 2008
First Posted Date June 9, 2008
Last Update Posted Date June 8, 2011
Study Start Date August 2000
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2011)
  • 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 ]
Original Primary Outcome Measures
 (submitted: June 6, 2008)
  • Relationship between intraoral metal contact allergy and epithelial carcinogenesis
  • Prevalence of metal contact allergy comparison to study control data
Change History Complete list of historical versions of study NCT00693550 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Contact Allergies to Dental Metal as a Possible Risk Factor for Oral Cancer
Official Title Oral Metal Contact Allergy: A Cause of Oral Squamous Cell Carcinoma?
Brief 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.

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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population otorhinolaryngology departments of Mayo Clinic Rochester and Mayo Clinic Arizona
Condition Head and Neck Cancer
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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 6, 2011)
115
Original Enrollment
 (submitted: June 6, 2008)
200
Actual Study Completion Date January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00693550
Other Study ID Numbers 497-00
P30CA015083 ( U.S. NIH Grant/Contract )
CDR0000589036 ( Other Identifier: Mayo Clinic )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party James A. Yiannias M.D., Mayo Clinic Cancer Center
Study Sponsor Mayo Clinic
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: James A. Yiannias, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date June 2011