[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549814":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":24,"locations":25,"responsibleParty":44,"collaborators":24,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":24,"enrollmentInfo":57,"targetDuration":24,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":72,"whyStopped":24,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Cardarelli Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"White Light Oral Examination (WLOE)","ACTIVE_COMPARATOR","Patients will undergo commone WLOE examination prior to do a required biopsy (see protocol for patients characteristics).",[13],"Other: Biopsy for diagnostical purposes",{"label":15,"type":16,"description":17,"interventionNames":18},"Narrow Band Imaging (NBI)","EXPERIMENTAL","Patients will have their biopsy guided by NBI (see protocol for patients characteristics).",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Biopsy for diagnostical purposes","Incisional biopsy is the current golden standard for OPMD\u002FOSCC diagnosis. Yet, the site it shall be performed is choosen by clinician at naked eyes. We will compare and study the results of performing the common golden standard biopsy site when guided by NBI.",[15,9],null,[26],{"facility":27,"status":24,"city":28,"state":24,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Agostino Guida","Naples","80131","Italy","IT",{"type":33,"coordinates":34},"Point",[35,36],14.26811,40.85216,{"lat":36,"lon":35},[39],{"name":40,"role":41,"phone":42,"phoneExt":24,"email":43},"Agostino Guida, DMD, PhD, MSc","CONTACT","+393333835451","agostino.guida@aocardarelli.it",{"type":45,"investigatorFullName":27,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Consultant","100549814","nbi-for-early-diagnosis-of-opmdoscc-100549814",false,"NCT06438939","NBI for Early Diagnosis of OPMD\u002FOSCC","Narrow Band Imaging (NBI) for Early Diagnosis of Oral Squamous Cell Carcinoma (OSCC) and Oral Potentially Malignant Disorders (OPMD)","NBI_Oral","Inclusion Criteria:\n\n* Patients with soft tissue, mucosal lesions of the oral cavity, who arrive for an initial first diagnosis (group 1);\n* Patients with history OPMD (clinically evident lesion\u002Fs group 2a, lesion\u002Fs excised group 2b), who are in follow-up (OPMDs included are eg. Leukoplakia, erythroleukoplakia, erythroplakia, oral lichen planus, oral lichenoid lesion);\n* Patients with history of HNSCC (OSCC group 3a, sinonasal, nasopharynx, oropharynx, larynx, oesophagus group 3b);\n* High risk (see above) individuals with no known oral mucosal disease (group 4);\n\nExclusion Criteria:\n\n* patients who did not need a biopsy nor after WLOE (e.g. normal mucosa, anatomical variation) nor after NBI (pattern I)\n* patients who, despite indication, were not suitable to undergo biopsy given his \u002F her systemic conditions","ALL","18 Years",{"count":58,"type":59},480,"ESTIMATED","INTERVENTIONAL",[62],"NA","Early detection - possibly at its pre-malignant stages (Oral Potentially Malignant Disorders, OPMD) - with periodic surveillance is thus fundamental for limiting disease burden, hopefully reducing the incidence of advanced stages OSCC and increasing survival. Narrow Band Imaging (NBI) has proved itself as promising tool for helping clinician both for diagnosis and therapy. Yet, there is no definitive scientific evidence that NBI is superior to common oral examination with white light (WLOE) for diagnosing OSCC\u002FOPMD. We thus propose a randomised clinical trial understand its role in this field.",[65,66],"Oral Squamous Cell Carcinoma","Oral Potentially Malignant Disorder",[68,69,70,71],"narrow band imaging","OSCC","OPMD","NBI","NOT_YET_RECRUITING","2024-05-27",{"date":75,"type":76},"2024-06-03","ACTUAL",{"date":78,"type":59},"2024-09-30",{"date":80,"type":59},"2026-12-31",{"name":5,"class":6},1]