Contact Allergies to Dental Metal as a Possible Risk Factor for Oral Cancer
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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
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Tracking Information | ||||
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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 |
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Original Primary Outcome Measures |
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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. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study.
NOTE: *Healthy volunteers (control) undergo metal patch testing using 8 metals most commonly positive for contact allergens. |
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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 |
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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. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
115 | |||
Original Enrollment |
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:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender |
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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 ) |
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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 |
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PRS Account | Mayo Clinic | |||
Verification Date | June 2011 |