[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502081":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":37,"studyPopulation":38,"armGroups":39,"interventions":33,"overallOfficials":43,"centralContacts":48,"locations":53,"responsibleParty":175,"collaborators":33,"id":177,"slug":33,"hasResults":178,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":33,"eligibilityCriteria":182,"healthyVolunteers":178,"sex":183,"minAge":184,"maxAge":33,"enrollmentInfo":185,"targetDuration":33,"studyType":188,"phases":33,"briefSummary":189,"conditions":190,"keywords":33,"overallStatus":68,"whyStopped":33,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},{"fullName":5,"class":6},"Centro di Riferimento Oncologico - Aviano","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Vitamin D variation","Difference in vitamin D levels between baseline and during radiotherapy","7 weeks",[14,18,22,26,29],{"measure":15,"description":16,"timeFrame":17},"Baseline vitamin D level and radiotherapy toxicity","Evaluation of the impact of baseline vitamin D levels on acute toxicity (mucositis, dermatitis and weight loss \\>10%)","8 weeks",{"measure":19,"description":20,"timeFrame":21},"Baseline vitamin D level and response","Evaluation of the impact of baseline vitamin D levels on response measured in term of ORR (Objective Response Rate)","12 weeks",{"measure":23,"description":24,"timeFrame":25},"Baseline vitamin D level and relapse free survival","Impact of baseline vitamin D levels on relapse free survival","up to 2 years",{"measure":27,"description":28,"timeFrame":25},"Baseline vitamin D level and survival","Impact of baseline vitamin D levels on overall survival",{"measure":30,"description":31,"timeFrame":32},"Variation of vitamin D level","Difference and relation between vitamin D levels at baseline and after 4 weeks","4 weeks",null,{"allocation":33,"interventionModel":33,"interventionModelDescription":33,"primaryPurpose":33,"observationalModel":35,"timePerspective":36,"maskingInfo":33},"COHORT","PROSPECTIVE","There are only a few works in the literature that correlate the circulating levels of vitamin D with the prognosis or development of toxicity in treated HNSCC patients with radical intent radiation therapy. These small studies have highlighted a worse outcome and greater toxicity in patients with low vitamin D levels. The study aims to study the variations in circulating levels of vitamin D in a multicenter cohort of patients with HSNCC prospectively collected and to evaluate the impact of vitamin D levels at diagnosis on the development of toxicity and on disease outcome","Patients of the participant centers with histologically proven HNSCC (squamous cell carcinomas)",[40],{"label":41,"type":33,"description":42,"interventionNames":33},"Head and Neck cancer patients","candidate to receive definitive or adjuvant radiation therapy with bilateral neck irradiation",[44],{"name":45,"affiliation":46,"role":47},"Giuseppe Fanetti, MD","Centro di Riferimento Oncologico (CRO), IRCCS","PRINCIPAL_INVESTIGATOR",[49],{"name":45,"role":50,"phone":51,"phoneExt":33,"email":52},"CONTACT","+390434659146","giuseppe.fanetti@cro.it",[54,67,84,97,109,120,131,141,152,163],{"facility":55,"status":56,"city":57,"state":58,"zip":33,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":33},"Ospedale Mons AR 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Scricciolo",{"facility":98,"status":99,"city":100,"state":33,"zip":33,"country":59,"countryCode":60,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Ospedali Riuniti","NOT_YET_RECRUITING","Ancona",{"type":62,"coordinates":102},[103,104],13.5103,43.60717,{"lat":104,"lon":103},[107],{"name":108,"role":50,"phone":33,"phoneExt":33,"email":33},"Clelia Di Carlo",{"facility":110,"status":99,"city":111,"state":33,"zip":33,"country":59,"countryCode":60,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"AORN San Pio","Benevento",{"type":62,"coordinates":113},[114,115],14.77816,41.1307,{"lat":115,"lon":114},[118],{"name":119,"role":50,"phone":33,"phoneExt":33,"email":33},"Angela Argenone",{"facility":121,"status":99,"city":122,"state":33,"zip":33,"country":59,"countryCode":60,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"IEO","Milan",{"type":62,"coordinates":124},[125,126],9.18951,45.46427,{"lat":126,"lon":125},[129],{"name":130,"role":50,"phone":33,"phoneExt":33,"email":33},"Daniela Alterio",{"facility":132,"status":99,"city":122,"state":33,"zip":33,"country":59,"countryCode":60,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Ospedale Niguarda",{"type":62,"coordinates":134},[135,136],12.59836,42.78235,{"lat":136,"lon":135},[139],{"name":140,"role":50,"phone":33,"phoneExt":33,"email":33},"Daniela Sibio",{"facility":142,"status":99,"city":143,"state":33,"zip":33,"country":59,"countryCode":60,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Ospedale del Mare","Naples",{"type":62,"coordinates":145},[146,147],14.26811,40.85216,{"lat":147,"lon":146},[150],{"name":151,"role":50,"phone":33,"phoneExt":33,"email":33},"Ida D'Onofrio",{"facility":153,"status":99,"city":154,"state":33,"zip":33,"country":59,"countryCode":60,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Azienda Ospedaliero Universitaria di Pisa","Pisa",{"type":62,"coordinates":156},[157,158],10.4036,43.70853,{"lat":158,"lon":157},[161],{"name":162,"role":50,"phone":33,"phoneExt":33,"email":33},"Stefano Ursino",{"facility":164,"status":68,"city":165,"state":33,"zip":166,"country":59,"countryCode":60,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Policlinico Umberto I","Roma","00161",{"type":62,"coordinates":168},[169,170],11.10642,44.99364,{"lat":170,"lon":169},[173],{"name":174,"role":50,"phone":33,"phoneExt":33,"email":33},"Francesca De Felice",{"type":176,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100502081",false,"NCT05817617","Vitamin D and Head and Neck Cancer: Impact on Toxicity and Prognosis","Vitamin D and Head and Neck Cancer: Impact on Toxicity and Prognosis: Prospective Multicenter Study of Head-Neck Group of the Italian Association of Radiotherapy and Clinical Oncology (AIRO)","Inclusion Criteria:\n\nhistologically proven HNSCC (squamous cell carcinomas), all subsites\n\n* non-metastatic locally advanced stages\n* patients candidate for radical or adjuvant radiotherapy\n* patients candidate for bilateral neck irradiation\n* written informed consent\n\nExclusion Criteria:\n\n* distant metastases\n* patients with known disorders of calcium\u002Fvitamin D metabolism","ALL","18 Years",{"count":186,"type":187},953,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about relation between vitamin D levels in subjects with head and neck cancer. The main question it aims to answer are:\n\n* variation of vitamin D levels in the study population at different time points\n* relation between therapy side effects and vitamin D level\n* relation between disease outcome and vitamin D level Participants will be followed as per clinical practice",[191],"Head and Neck Cancer","2023-10-24",{"date":194,"type":195},"2023-10-25","ACTUAL",{"date":197,"type":195},"2021-08-08",{"date":199,"type":187},"2026-08",{"name":5,"class":6},10]