[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468091":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":40,"locations":45,"responsibleParty":77,"collaborators":79,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":10,"enrollmentInfo":95,"targetDuration":10,"studyType":98,"phases":10,"briefSummary":99,"conditions":100,"keywords":106,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of Erlangen-Nürnberg Medical School","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Cohort",null,"The study cohort consist of patients with newly diagnosed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, paranasal sinuses or larynx in stage UICC (Union internationale contre le cancer) II-IVB",[13],"Other: Sampling",{"label":15,"type":10,"description":16,"interventionNames":17},"Control Group","The control group consists of patients with no current diagnoses of cancer undergoing surgery at the participating medical center",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"Sampling","This is an observational study. Consequently, study participation does not alter the therapy of the treated disease. Blood will be drawn from patients at several time points during and after radiotherapy (RT) and therapy with immune checkpoint inhibitor (ICI) for detailed immunomonitoring of the patients. In addition, faeces and sputum of the patients for microbiomic and metabolomic measures will be collected. Whenever possible, adequate tissue samples are taken from the center of the tumor and a biopsy is taken from the edge of the tumor including the adjacent mucosa in the nearby area without affecting the pathological assessment (study group). Blood, faeces and sputum will be taken from patients of the control group prior to surgery. After surgery, only blood will be taken.",[15,9],[24,28,31,35,38],{"name":25,"affiliation":26,"role":27},"Antoniu-Oreste Gostian, PD Dr. med.","ENT - Head and Neck Surgery Department, University of Erlangen-Nurnberg","STUDY_DIRECTOR",{"name":29,"affiliation":30,"role":27},"Markus Hecht, PD Dr. med.","Radiation Oncology, University of Erlangen-Nurnberg",{"name":32,"affiliation":33,"role":34},"Manuel Weber, PD Dr. med. Dr. med. dent.","Maxillo-facial-surgery, University of Erlangen-Nurnberg","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Udo Gaipl, Prof. Dr. rer. nat. habil.","Translational Radiobiology, University of Erlangen-Nurnberg",{"name":39,"affiliation":37,"role":34},"Benjamin Frey, PD Dr.-Ing. Dr. habil. med.",[41],{"name":25,"role":42,"phone":43,"phoneExt":10,"email":44},"CONTACT","+49 9131 85-33156","antoniu-oreste.gostian@uk-erlangen.de",[46,62,70],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"ENT - Head and Neck Surgery Department","RECRUITING","Erlangen","Bavaria","91054","Germany","DE",{"type":55,"coordinates":56},"Point",[57,58],11.00783,49.59099,{"lat":58,"lon":57},[61],{"name":25,"role":42,"phone":43,"phoneExt":10,"email":44},{"facility":63,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":64,"geoPoint":66,"contacts":67},"Maxillo-Facial-Surgery Department",{"type":55,"coordinates":65},[57,58],{"lat":58,"lon":57},[68],{"name":69,"role":42,"phone":10,"phoneExt":10,"email":10},"Manuel Weber, PD Dr. med.",{"facility":71,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":72,"geoPoint":74,"contacts":75},"Radiation Oncology Department",{"type":55,"coordinates":73},[57,58],{"lat":58,"lon":57},[76],{"name":29,"role":42,"phone":10,"phoneExt":10,"email":10},{"type":78,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[80,82,84],{"name":81,"class":6},"University Hospital Erlangen",{"name":83,"class":6},"University Hospital Regensburg",{"name":85,"class":6},"University Hospital Augsburg","100468091","immune-biomarker-study-for-head-and-neck-cancer-100468091",false,"NCT05375266","Immune Biomarker Study for Head and Neck Cancer","ImmunBio-KHT","Inclusion Criteria:\n\n* Initial diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, paranasal sinuses or larynx in stage UICC II-IVB (study group)\n* Diseases other than malignant diseases (patients with the indication for surgery of the ear, nose nose or maxillofacial surgery) (control group)\n* Absence of a currently existing or previous malignant disease regardless of the anatomical localization (control group)\n* Agreement of the patients for sampling blood, saliva and stool as well as consent to the preservation of all samples for further study purposes\n* Age ≥ 18 years\n* Cognitive ability of the patients to understand the meaning and purpose of the study and agree to it\n\nExclusion Criteria:\n\n* Distant metastases and \u002F or simultaneous secondary carcinoma at the time of diagnosis (= inclusion date)\n* Carcinomas in which it is (likely) impossible to take a sample without interfering with the further pathological assessment\n* Present drug abuse\n* Patients who are unable or unwilling to behave and receive treatment according to protocol\n* Patients who are legally patronized\n* Patients who are not eligible for participation in the study due to language barrier","ALL","18 Years",{"count":96,"type":97},1100,"ESTIMATED","OBSERVATIONAL","The aim of this prospective non-interventional multi-center trial is to study the prognostic value of intratumoral and systemic immune biomarkers in newly diagnosed non-metastatic head and neck cancer. Furthermore, the local immunological processes in the tumor will be correlated with the systemic immune status determined in the peripheral blood to identify prognostic immune signatures. In addition, tumor organoids will be generated ex vivo for functional biological analyses. The main objective is to create a prognostic score determined by clusters based on tumor immunologic criteria.",[101,102,103,104,105],"Head and Neck Cancer","Oral Cavity Cancer","Oropharyngeal Cancer","Hypopharyngeal Cancer","Laryngeal Cancer",[107,108],"Immunologic markers","Immunotherapy","2023-05-16",{"date":111,"type":112},"2023-05-17","ACTUAL",{"date":114,"type":112},"2022-05-16",{"date":116,"type":97},"2027-03-31",{"name":5,"class":6},3]