Head and Neck CancerNCT00693550
Contact Allergies to Dental Metal as a Possible Risk Factor for Oral Cancer
An observational study of Head and Neck Cancer, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- metal patch tests
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: otorhinolaryngology departments of Mayo Clinic Rochester and Mayo Clinic Arizona
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- metal patch tests
- Keywords
- lip and oral cavity squamous cell carcinoma, oropharyngeal squamous cell carcinoma
- Medical subject headings
- Head and Neck Neoplasms, Lymphoid Interstitial Pneumonia, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metal patch testsOther
Twenty - seven (27) metal patch tests will be applied to the patient's back and left in place for 3 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between intraoral metal contact allergy and epithelial carcinogenesis
Measured: one year
Prevalence of metal contact allergy comparison to study control data
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startAug 2000
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- James A. Yiannias, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693550
- Sponsor's protocol ID
- 497-00
- Other IDs
- P30CA015083, CDR0000589036
- Status last verified
- Jun 2011
- First submitted
- 6 Jun 2008
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Metal Contact Allergy: A Cause of Oral Squamous Cell Carcinoma?
- ClinicalTrials.gov ID
- NCT00693550
- Acronym / sponsor ID
- 497-00
- Conditions
- Head and Neck Cancer
- Keywords
- lip and oral cavity squamous cell carcinoma, oropharyngeal squamous cell carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2000
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 9 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- otorhinolaryngology departments of Mayo Clinic Rochester and Mayo Clinic Arizona
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metal patch testsTwenty - seven (27) metal patch tests will be applied to the patient's back and left in place for 3 days | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A. Yiannias, MD study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between intraoral metal contact allergy and epithelial carcinogenesis (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.