Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-01-06 @ 4:23 PM
Study NCT ID:
NCT05942794
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Oral Lesions Through an Autofluorescence System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007972', 'term': 'Leukoplakia, Oral'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D017676', 'term': 'Lichen Planus, Oral'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D008010', 'term': 'Lichen Planus'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007971', 'term': 'Leukoplakia'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The screening will start after a first oral examination, in order to rule out noticeable mucosal lesions.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2023-07-10', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical change of oral mucosa', 'timeFrame': 'baseline and after 21 days', 'description': 'Presence of a white, red, or mixed mucosal area with an exophytic or vegetative appearance or with loss of substance'}, {'measure': 'Fluorescence change of oral mucosa', 'timeFrame': 'baseline and after 21 day', 'description': 'Presence of a mucosal area with reduced or increased fluorescence'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral Leukoplakia', 'Lichen Planus', 'Squamous cell carcinoma', 'Keratosis'], 'conditions': ['Oral Leukoplakia', 'Autofluorescence', 'Secondary Prevention', 'Keratosis', 'Oral Lichen Planus', 'Oral Cancer', 'Oral Disease']}, 'descriptionModule': {'briefSummary': 'The aim of the study will be to evaluate the efficacy of a tissue autofluorescence detection system as an aid to clinical screening in identifying lesions of the oral mucosa. The screening process will be performed by 3 clinicians with a different level of experience. Sensitivity and specificity tests will be conducted.', 'detailedDescription': 'Tissue autofluorescence analysis will be performed using GOOCLES® glasses, a device capable of detecting variations in fluorescence when the examined area is illuminated with a common photopolymerising lamp. Three clinical professionals will be identified:\n\n* Dental hygienist (1);\n* General dentist (2);\n* Dentist expert in Medicine and Oral Pathology (3).\n\nAll patients will be included in the study after receiving an initial dental visit, in order to rule out patients with noticeable oral lesions.\n\nDental hygienist (1) will collect the patient\'s data by filling the "anamnestic record". Furthermore, (1) will perform the first clinical examination (with and without GOOCLES®), reporting his observations on his own "operator module".\n\nThe same screening (with and without GOOCLES®) will be conducted blindly by the general dentist (2) who, if he deems it necessary, will refer the patient to the oral pathologist (3), who will confirm or not (with and without GOOCLES®) the presence of an oral region such as to be further investigated (follow up or biopsy) and will report the observations on its own "operator module".\n\nInter-operator and intra-operator comparisons will be performed and the data thus obtained will be processed for statistical processing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female;\n* Age ≥ 18 years;\n* Non-smokers and smokers\n\nExclusion Criteria:\n\n* Cancer patients;\n* Patients presenting a histological diagnosis of oral mucosal dysplasia/carcinoma.'}, 'identificationModule': {'nctId': 'NCT05942794', 'briefTitle': 'Identification of Oral Lesions Through an Autofluorescence System', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Use of a Tissue Autofluorescence Detection System for Identification of Oral Mucosal Lesions', 'orgStudyIdInfo': {'id': '177/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening examination', 'description': 'All patients will undergo a screening examination (with or without GOCCLES ® glasses) by all three operators.', 'interventionNames': ['Device: Screening examination']}], 'interventions': [{'name': 'Screening examination', 'type': 'DEVICE', 'description': 'After an initial clinical visit, all three operators will wear the tissue autofluorescence detection device (GOCCLES®), reporting both observations on their "operator-module".', 'armGroupLabels': ['Screening examination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Ramaglia', 'role': 'CONTACT', 'email': 'luca.ramaglia@unina.it', 'phone': '+393476912911'}], 'facility': 'University of Naples Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'centralContacts': [{'name': 'Luca Ramaglia', 'role': 'CONTACT', 'email': 'luca.ramaglia@unina.it', 'phone': '+393476912911'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Luca Ramaglia', 'investigatorAffiliation': 'Federico II University'}}}}