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

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 Outcome Measures	Not Provided
Original Other 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