[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482464":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":33,"centralContacts":41,"locations":46,"responsibleParty":71,"collaborators":22,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":22,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":22,"enrollmentInfo":83,"targetDuration":22,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":48,"whyStopped":22,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Universidad Rey Juan Carlos","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients","EXPERIMENTAL","73 patients are to be recruited from the ones that go to the oral medicine service at the university clinic of Rey Juan Carlos in Madrid that present a compatible clinic diagnostic compatible with oral potentially malignant disorders. Each patient will receive first an intraoral exploration, taking note of location and size of the injury. After that, an exploration with the GOCCLES® device will be made, also taking note of the location and size data. Thereafter, the blue toluidine stain will be used, taking note of the size and location of the marked areas. Pictures will be taken through all the steps. Finally, a biopsy will be made of the area or areas the clinic considers and\u002For marked by the device or the toluidine blue.",[13,14,15],"Device: GOCCLES","Diagnostic Test: Toluidine blue stain","Procedure: Biopsy",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DEVICE","GOCCLES","Inspection using GOCCLES®. An UV light source will be administered, with polymerization lamp sdi radii xpert, with a potency of 1500 mW\u002Fcm2 and a wavelength of 440-480nm, applied at 20cm of the injury.\n\nNotes will be taken on the location and size of the injury observed with the device.\n\nImage register using the GOCCLES® photographic filter for mobile devices. The same light source will be used.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"DIAGNOSTIC_TEST","Toluidine blue stain","To value the toluidine blue diagnosis capacity, the sequence described by Mashberg will be followed: The patient will realize a mouthwash with acetic acid at 1% for 20 seconds. Two using water for 20 seconds. Toluidine blue at 1% will be applied for 20 seconds. New mouthwash with acetic acid for 60 seconds and a final mouthwash with water.\n\nNotes on the and pictures will be taken on the location and size of the injury.",[9],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":22},"PROCEDURE","Biopsy","The area to biopsy will be chosen, and, using local anaesthesia, it will be resected. The specimens will be sent to the oral and maxillofacial pathology diagnostic service of the University of Basque Country for anatomopathological study",[9],[34,38],{"name":35,"affiliation":36,"role":37},"Rocío Teresa Martín Muñoz","Universidad Rey Juan Carlos de Madrid","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":36,"role":40},"Antonio Francisco López Sánchez","STUDY_DIRECTOR",[42],{"name":35,"role":43,"phone":44,"phoneExt":22,"email":45},"CONTACT","645468417","rt.martin@alumnos.urjc.es",[47],{"facility":36,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Alcorcón","Madrid","28922","Spain","ES",{"type":55,"coordinates":56},"Point",[57,58],-3.82487,40.34582,{"lat":58,"lon":57},[61,62,65,66,68,70],{"name":35,"role":43,"phone":44,"phoneExt":22,"email":45},{"name":63,"role":64,"phone":22,"phoneExt":22,"email":22},"María Victoria Fuentes Fuentes","SUB_INVESTIGATOR",{"name":39,"role":64,"phone":22,"phoneExt":22,"email":22},{"name":67,"role":64,"phone":22,"phoneExt":22,"email":22},"Blanca del Carmen Migueláñez Medrán",{"name":69,"role":64,"phone":22,"phoneExt":22,"email":22},"Jesús Rodríguez Molinero",{"name":35,"role":37,"phone":22,"phoneExt":22,"email":22},{"type":37,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Rocío Teresa Martín Munoz","Bachelor of Dentistry and Specialist in Oral Medicine","100482464","predictive-value-of-goccles-device-for-early-diagnosis-of-oral-potentially-malignant-disorders-100482464",false,"NCT05562375","Predictive Value of GOCCLES® Device for Early Diagnosis of Oral Potentially Malignant Disorders","Predictive Value of GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), Device for Early Diagnosis of Oral Potentially Malignant Disorders","Inclusion Criteria:\n\n* Patients older than 18.\n* Patients that present oral mucosa injuries compatible with OPMD.\n* Patients that understand the purpose of the study and express consent\n\nExclusion Criteria:\n\n* Patients that don't have the capability to express consent.\n* Patients with systemic pathologies that contraindicate a biopsy.\n* Patients with a recent biopsy at the oral cavity","ALL","18 Years",{"count":84,"type":85},73,"ESTIMATED","INTERVENTIONAL",[88],"NA","Oral potentially malignant disorders (OPMDs) are chronic pathologies which can suffer dysplastic alterations and evolve into oral cancer.\n\nThe diagnosis of those pathologies is commonly done by visual inspection, which is not capable of determining the presence or not of dysplasia. Furthermore, this type of diagnosis depends greatly on the expertise and training of the professional.\n\nIn recent years, new methods that can help early oral cancer diagnosis have been developed. A new device has been commercialized, named GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), based on the autofluorescence principle.\n\nThe hypothesis of this study is that GOCCLES® device could be an effective tool to help in early detection of oral cancer.",[91,92],"Oral Potentially Malignant Disorders","Oral Cancer",[19,94,95,96],"Autofluorescence","Oral cancer","Oral dysplasia","2022-09-30",{"date":99,"type":100},"2022-10-04","ACTUAL",{"date":102,"type":100},"2022-01-08",{"date":104,"type":85},"2026-09-30",{"name":5,"class":6},1]