[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553741":3},{"organization":4,"armGroups":7,"interventions":83,"overallOfficials":93,"centralContacts":98,"locations":104,"responsibleParty":117,"collaborators":10,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":127,"sex":128,"minAge":129,"maxAge":10,"enrollmentInfo":130,"targetDuration":133,"studyType":134,"phases":10,"briefSummary":135,"conditions":136,"keywords":10,"overallStatus":107,"whyStopped":10,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Direction Centrale du Service de Santé des Armées","OTHER",[8,14,17,20,23,26,29,32,35,38,41,44,48,51,54,57,60,65,68,71,74,77,80],{"label":9,"type":10,"description":11,"interventionNames":12},"A:Previously exposed to CISPLATIN with significant ATL damage",null,"Groupe A",[13],"Diagnostic Test: Auditory, vestibular and electrophysiological investigations",{"label":15,"type":10,"description":11,"interventionNames":16},"A:Previously exposed to CISPLATIN without significant ATL damage",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"A:Previously exposed to cochlear RADIOTHERAPY with significant ATL damage",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"A:Previously exposed to cochlear RADIOTHERAPY WITHOUT significant ATL damage",[13],{"label":24,"type":10,"description":11,"interventionNames":25},"A:Previously exposed to cochlear RADIOTHERAPY & CISPLATIN with significant ATL damage",[13],{"label":27,"type":10,"description":11,"interventionNames":28},"A:Previously exposed to cochlear RADIOTHERAPY & CISPLATIN WITHOUT significant ATL damage",[13],{"label":30,"type":10,"description":11,"interventionNames":31},"A:Previously exposed to OXALIPLATIN",[13],{"label":33,"type":10,"description":11,"interventionNames":34},"A:Previously exposed to CARBOPLATIN",[13],{"label":36,"type":10,"description":11,"interventionNames":37},"A:Previously exposed to TAXANES",[13],{"label":39,"type":10,"description":11,"interventionNames":40},"A:Previously exposed to VINCALCALOIDS",[13],{"label":42,"type":10,"description":11,"interventionNames":43},"A:Previously exposed to other neurotoxicant",[13],{"label":45,"type":10,"description":46,"interventionNames":47},"B:Patients cured of cancer without ototoxic or neurotoxic exposure","Groupe B",[13],{"label":49,"type":10,"description":46,"interventionNames":50},"B:Companions without ototoxic or neurotoxic exposure",[13],{"label":52,"type":10,"description":11,"interventionNames":53},"A:Hyperacusic patients following cancer treatment",[13],{"label":55,"type":10,"description":11,"interventionNames":56},"A:Tinnitus patients following cancer treatment",[13],{"label":58,"type":10,"description":11,"interventionNames":59},"A:Patients with vestibular disorders following cancer treatment",[13],{"label":61,"type":10,"description":62,"interventionNames":63},"C:Patients with an indication for CISPLATIN recruited prior to any treatment","Groupe C",[13,64],"Diagnostic Test: Biologic investigations; seric proteins",{"label":66,"type":10,"description":62,"interventionNames":67},"C:Patients indicated for cochlear radiotherapy and recruited prior to treatmen",[13,64],{"label":69,"type":10,"description":62,"interventionNames":70},"C:Patients with indication for CISPLATIN and cochlear radiotherapy recruited prior any treatment",[13,64],{"label":72,"type":10,"description":62,"interventionNames":73},"C:Patients with an indication for OXALIPLATIN treatment recruited prior to any treatment",[13,64],{"label":75,"type":10,"description":62,"interventionNames":76},"C:Patients with indication for CARBOPLATIN recruited prior to any treatment",[13,64],{"label":78,"type":10,"description":62,"interventionNames":79},"C:Patients with indication for TAXANES therapy recruited prior to any treatment",[13,64],{"label":81,"type":10,"description":62,"interventionNames":82},"C:Patients with indication for VINCALCALOIDES or other neurotoxicant",[13,64],[84,89],{"type":85,"name":86,"description":87,"armGroupLabels":88,"otherNames":10},"DIAGNOSTIC_TEST","Auditory, vestibular and electrophysiological investigations","otoacoustic emissions, electrocochleography, vocal audiometry in noise and high-frequency tonal audiometry, impedancemetry",[52,58,33,9,15,30,36,39,27,24,21,18,42,55,49,45,66,61,72,75,69,78,81],{"type":85,"name":90,"description":91,"armGroupLabels":92,"otherNames":10},"Biologic investigations; seric proteins","seric proteins",[66,61,72,75,69,78,81],[94],{"name":95,"affiliation":96,"role":97},"François Régis FERRAND","IRBA, 1 place Valérie André, 91 223 Brétigny-sur-Orge cedex","STUDY_CHAIR",[99],{"name":100,"role":101,"phone":102,"phoneExt":10,"email":103},"François-Régis FERRAND","CONTACT","0178651249","francois-regis.ferrand@def.gouv.fr",[105],{"facility":106,"status":107,"city":108,"state":10,"zip":10,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":10},"HIA Bégin","RECRUITING","Paris","France","FR",{"type":112,"coordinates":113},"Point",[114,115],2.3488,48.85341,{"lat":115,"lon":114},{"type":118,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100553741","diagnostic-of-various-ototoxicity-induced-by-cancer-treatment-100553741",false,"NCT06490029","Diagnostic of Various Ototoxicity Induced by Cancer Treatment","Evaluation of Hidden Hearing Loss and Vestibular Damage Induced by Anti-cancer Treatments","BIO-OTOTOX","Inclusion Criteria:\n\n* Age 18 and over\n* Registered with social security\n* Signed consents\n* Absence of presbycusis prior to cancer treatment (groups A and C)\n* No known presbycusis (group B)\n* Previous exposure to an ototoxic\u002Fneurotoxic agent (group A)\n* Indication for initiation of ototoxic\u002Fneurotoxic therapy (group C)\n\nExclusion Criteria:\n\n* \\- Subjects deprived of liberty\n* Subjects unable to read or write the French language\n* Pregnant and breast-feeding women\n* Previous treatment for ototoxicity\n* History of bilateral auditory pathology, in particular otosclerosis, perilymphatic fistula, ruptured tympanic membrane, autoimmune hearing loss, acoustic neuroma.\n* History of severe head trauma (Glasgow Coma Score \\\u003C= 8)\n* Abnormal otoscopy or tympanometry In addition for group B\n* Previous chemotherapy\n* Previous ENT radiotherapy\n* Ongoing ototoxic drug therapy (quinine, diuretics, aminoglycosides, aspirin, NSAIDs) or corticosteroid therapy",true,"ALL","18 Years",{"count":131,"type":132},540,"ESTIMATED","39 Months","OBSERVATIONAL","• Visit the clinic once every 2 weeks for checkups and tests The goal of this clinical trial is to learn if systematic hearing tests (eg fonctional assesment, electrophysiology and seric biomarkers) can diagnose hidden hearing loss or vestibular troubles in a population of patients treated for cancer; population study will include different population in terms of sex\u002Fgender, age, medical condition (cancer patients treated with surgery alone and\u002For radiotherapy and\u002For chemotherapy, and healthy volunteers).\n\nThe main question it aims to answer is:\n\n• To assess the ototoxicity of anticancer drugs using a combination of auditory functional tests (including speech audiometry in noise), vestibular test , plasmatic samples and electrophysiological measures.\n\nParticipants will be studied:\n\nEither only after exposition (single visit) Or before, during and after the exposition to potential otototoxic agents with a 4 times Visit the clinic checkups and tests (one before, two while ongoing potential ototoxic agents and 1 post exposition)\n\nParticipants will complete questionnaires, undergo audiometric and electrophysiological tests, and their routine biomedical data will be studied, without any modification of the routine care (planned cancer treatment)",[137],"Ototoxicity, Drug-Induced","2024-06-28",{"date":140,"type":141},"2024-07-08","ACTUAL",{"date":143,"type":141},"2024-06-19",{"date":145,"type":132},"2027-09-19",{"name":5,"class":6},1]