[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585652":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":21,"centralContacts":26,"locations":31,"responsibleParty":50,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":10,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":10,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"National Cancer Institute, Naples","OTHER",[8,13],{"label":9,"type":10,"description":10,"interventionNames":11},"Group A: Patients undergoing surgery followed by chemo-radiotherapy",null,[12],"Other: Biomarkers evaluation",{"label":14,"type":10,"description":10,"interventionNames":15},"Group B: Patients undergoing exclusive chemo-radiotherapy with CDDP, CBDCA, or Cetuximab",[12],[17],{"type":6,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"Biomarkers evaluation","Evaluate the prognostic role of the markers TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, ERCC1 examined on biopsy samples.",[9,14],[22],{"name":23,"affiliation":24,"role":25},"Francesco Perri, MD","IRCCS I.N.T. \"G. Pascale\"","PRINCIPAL_INVESTIGATOR",[27],{"name":23,"role":28,"phone":29,"phoneExt":10,"email":30},"CONTACT","08117770403","f.perri@istitutotumori.na.it",[32],{"facility":33,"status":34,"city":35,"state":10,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Istituto Nazionale Tumori | \"Fondazione Pascale\"","RECRUITING","Naples","80131","Italy","IT",{"type":40,"coordinates":41},"Point",[42,43],14.26811,40.85216,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":48,"phoneExt":10,"email":49},"Francesco MD Perri","0117770403","f.perri@istitutumori.na.it",{"type":51,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100585652","molecular-based-selection-of-patients-with-head-and-neck-squamous-cell-carcinoma-biomarker-analysis-100585652",false,"NCT06905145","Molecular-Based Selection of Patients with Head and Neck Squamous Cell Carcinoma: Biomarker Analysis","Inclusion Criteria:\n\n1. Patients aged \\> 18 years\n2. Written informed consent approved by the competent Independent Ethics Committee\n3. Histopathological diagnosis of squamous cell carcinoma of the head and neck region originating from one of the following organs or structures: Oral cavity, oropharynx, larynx, hypopharynx\n4. Locally advanced stage: from T1N1M0 to T4N3M0\n5. Availability of a tissue sample from a biopsy performed according to clinical practice guidelines.\n\nExclusion Criteria:\n\n1. Recurrent\u002Fmetastatic disease\n2. Presence of a synchronous second tumor","ALL","18 Years",{"count":61,"type":62},128,"ESTIMATED","OBSERVATIONAL","This is an observational, prospective study enrolling patients who meet the inclusion criteria and provide consent for the use of biopsy samples collected as part of standard clinical practice. The analysis will focus on the following biomarkers: TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, and ERCC1.\n\nThese biomarkers will be examined in both observation groups.",[66,67],"Head and Neck Squamous Cell Carcinoma","Locally Advanced Stage","2025-03-25",{"date":70,"type":71},"2025-04-01","ACTUAL",{"date":73,"type":71},"2024-05-03",{"date":75,"type":62},"2032-05",{"name":5,"class":6},1]