Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-02-20 @ 3:44 PM
Study NCT ID:
NCT00693550
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2008-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contact Allergies to Dental Metal as a Possible Risk Factor for Oral Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'C562489', 'term': 'Lymphoid Interstitial Pneumonia'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-06', 'studyFirstSubmitDate': '2008-06-06', 'studyFirstSubmitQcDate': '2008-06-06', 'lastUpdatePostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relationship between intraoral metal contact allergy and epithelial carcinogenesis', 'timeFrame': 'one year'}, {'measure': 'Prevalence of metal contact allergy comparison to study control data', 'timeFrame': 'one year'}]}, 'conditionsModule': {'keywords': ['lip and oral cavity squamous cell carcinoma', 'oropharyngeal squamous cell carcinoma'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: This clinical trial is studying contact allergies to dental metal as a possible risk factor for oral cancer.', 'detailedDescription': "OBJECTIVES:\n\n* Identify the relationship between intraoral metal contact allergy and epithelial carcinogenesis in patients with newly or previously diagnosed intraoral squamous cell carcinoma.\n* Compare the prevalence of metal contact allergy in these patients with control data from other existing study populations.\n\nOUTLINE: This is a multicenter study.\n\n* 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.\n\nNOTE: \\*Healthy volunteers (control) undergo metal patch testing using 8 metals most commonly positive for contact allergens."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'otorhinolaryngology departments of Mayo Clinic Rochester and Mayo Clinic Arizona', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Meets 1 of the following criteria:\n\n * Newly or previously diagnosed oral squamous cell carcinoma\n\n * Recruited from the otorhinolaryngology departments of Mayo Clinic Rochester and Mayo Clinic Arizona\n * Healthy volunteer (control)\n\n * No history of intraoral squamous cell carcinoma\n * Employed at Mayo Clinic Rochester or Mayo Clinic Arizona\n\nPATIENT CHARACTERISTICS:\n\n* No immunosuppression\n* No other conditions that interfere with patch testing\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00693550', 'briefTitle': 'Contact Allergies to Dental Metal as a Possible Risk Factor for Oral Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Oral Metal Contact Allergy: A Cause of Oral Squamous Cell Carcinoma?', 'orgStudyIdInfo': {'id': '497-00'}, 'secondaryIdInfos': [{'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}, {'id': 'CDR0000589036', 'type': 'OTHER', 'domain': 'Mayo Clinic'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'metal patch tests', 'type': 'OTHER', 'description': "Twenty - seven (27) metal patch tests will be applied to the patient's back and left in place for 3 days"}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'James A. Yiannias, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'James A. Yiannias M.D.', 'oldOrganization': 'Mayo Clinic Cancer Center'}}}}