[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585652":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":24,"studyPopulation":25,"armGroups":26,"interventions":34,"overallOfficials":39,"centralContacts":44,"locations":49,"responsibleParty":68,"collaborators":11,"id":70,"slug":11,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":11,"eligibilityCriteria":74,"healthyVolunteers":71,"sex":75,"minAge":76,"maxAge":11,"enrollmentInfo":77,"targetDuration":11,"studyType":80,"phases":11,"briefSummary":81,"conditions":82,"keywords":11,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"National Cancer Institute, Naples","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of P53 Expression in Tumor Tissue in Groups A and B",null,"84 months",[14,18],{"measure":15,"description":16,"timeFrame":17},"Overall Survival (OS)","Describe the Overall Survival (OS) outcomes obtained in both Groups under observation.","84 monhts",{"measure":19,"description":20,"timeFrame":17},"Association between Overall Survival (OS) and the expression of biomarkers","Define the association between Overall Survival (OS) and the expression of biomarkers (TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, ERCC1) in both Groups under observation.",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":22,"timePerspective":23,"maskingInfo":11},"COHORT","PROSPECTIVE","The primary objective of this project is to evaluate the prognostic role of the biomarker P53, as numerous studies suggest its association with poor prognosis. This analysis will be particularly relevant for p16-positive (HPV-related) patients, who are currently considered a good prognosis category. The study aims to determine whether cases with overexpression of both p16 and P53 deviate from this assumption.\n\nA secondary objective is to validate a molecular signature in clinical practice, composed of multiple biomarkers, to assess whether specific combinations can predict treatment response.\n\nThe biomarkers TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, and ERCC1 will be analyzed on biopsy samples from patients with newly diagnosed, locally advanced squamous cell carcinoma of the head and neck.\n\nThe study population consists of patients with locally advanced Head and Neck Squamous Cell Carcinoma who have an available biopsy sample collected as part of standard clinical practice. The groups will be classified based on the treatment received:\n\n* Group A: Patients undergoing surgery followed by chemoradiotherapy.\n* Group B: Patients receiving exclusive chemoradiotherapy with CDDP, CBDCA, or Cetuximab.","The study population consists of patients with locally advanced Head and Neck Squamous Cell Carcinoma who will have a biopsy sample obtained according to clinical practice. These groups will be divided based on the treatment received:\n\n* \\*\\*Group A\\*\\*: Patients undergoing surgery followed by chemo-radiotherapy\n* \\*\\*Group B\\*\\*: Patients undergoing exclusive chemo-radiotherapy with CDDP, CBDCA, or Cetuximab",[27,31],{"label":28,"type":11,"description":11,"interventionNames":29},"Group A: Patients undergoing surgery followed by chemo-radiotherapy",[30],"Other: Biomarkers evaluation",{"label":32,"type":11,"description":11,"interventionNames":33},"Group B: Patients undergoing exclusive chemo-radiotherapy with CDDP, CBDCA, or Cetuximab",[30],[35],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"Biomarkers evaluation","Evaluate the prognostic role of the markers TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, ERCC1 examined on biopsy samples.",[28,32],[40],{"name":41,"affiliation":42,"role":43},"Francesco Perri, MD","IRCCS I.N.T. \"G. Pascale\"","PRINCIPAL_INVESTIGATOR",[45],{"name":41,"role":46,"phone":47,"phoneExt":11,"email":48},"CONTACT","08117770403","f.perri@istitutotumori.na.it",[50],{"facility":51,"status":52,"city":53,"state":11,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Istituto Nazionale Tumori | \"Fondazione Pascale\"","RECRUITING","Naples","80131","Italy","IT",{"type":58,"coordinates":59},"Point",[60,61],14.26811,40.85216,{"lat":61,"lon":60},[64],{"name":65,"role":46,"phone":66,"phoneExt":11,"email":67},"Francesco MD Perri","0117770403","f.perri@istitutumori.na.it",{"type":69,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":78,"type":79},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.",[83,84],"Head and Neck Squamous Cell Carcinoma","Locally Advanced Stage","2025-03-25",{"date":87,"type":88},"2025-04-01","ACTUAL",{"date":90,"type":88},"2024-05-03",{"date":92,"type":79},"2032-05",{"name":5,"class":6},1]