[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511011":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":62,"collaborators":10,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":10,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Royal Marsden NHS Foundation Trust","OTHER",[8,12,17],{"label":9,"type":10,"description":11,"interventionNames":10},"Retrospective observational cohort",null,"Retrospective patients undergoing transoral robotic surgery for early stage T1-2 oropharyngeal cancers on or before to 31\u002F12\u002F2021. Data will be collected from medical records.",{"label":13,"type":10,"description":14,"interventionNames":15},"Exploratory molecular analysis","Consenting prospective patients based in the UK identified will be invited to participate in the exploratory molecular analysis by their usual care team. If agreeable, patients will consent to donation of either blood or buccal swab samples, in addition to archival tissue from their primary, and if relevant, recurrent tissue samples.",[16],"Genetic: Molecular Analysis",{"label":18,"type":10,"description":19,"interventionNames":20},"Radiology\u002F radiomic analysis","Retrospective patients based in the UK and abroad will have their pre-operative imaging transferred to the RMH radiology department which will undergo radiomic and morphological assessment to ascertain features that put patients at high risk of local recurrence and positive margins.",[21],"Other: Radiomic\u002F Morphological analysis",[23,28],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"GENETIC","Molecular Analysis","Germline and circulating tumour DNA analysis of buccal\u002F blood samples and molecular analysis of primary and recurrent tumour tissue samples",[13],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"Radiomic\u002F Morphological analysis","Radiomic analysis and assessment of morphological features of pre-operative CT\u002F MRI imaging in patients who have undergone TORS for primary oropharyngeal cancer.",[18],[33],{"name":34,"affiliation":35,"role":36},"Vinidh Paleri","Royal Marsden Hospital NHS Foundation Trust","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":10,"email":42},"Andrew Williamson","CONTACT","02000000000","andrew.williamson2@rmh.nhs.uk",{"name":44,"role":40,"phone":41,"phoneExt":10,"email":45},"Reyhaneh Sadegh Zadeh","reyhaneh.sadeghzadeh@rmh.nhs.uk",[47],{"facility":48,"status":49,"city":50,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"The Royal Marsden Hospital NHS Foundation Trust","RECRUITING","London","United Kingdom","UK",{"type":54,"coordinates":55},"Point",[56,57],-0.12574,51.50853,{"lat":57,"lon":56},[60],{"name":39,"role":40,"phone":10,"phoneExt":10,"email":61},"RESCUE@rmh.nhs.uk",{"type":63,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100511011","single-and-combined-modality-trans-oral-robotic-surgery-in-early-oropharyngeal-cancer-100511011",false,"NCT05933889","Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer","Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence: The SCORE Study","SCORE","Inclusion Criteria:\n\n* 18 years and older.\n* Primary tumour within the oropharynx (defined as tonsil, soft palate, tongue base, lateral and posterior oropharyngeal walls)\n* Histologically confirmed squamous cell carcinoma.\n* P16 positive or negative tumours\n* Index cancer treated with TORS with or without adjuvant therapy.\n* Early pT1-T2 stage oropharyngeal SCC\n* TORS performed on or before 31st December 2021\n\nFor the exploratory analysis only:\n\n* Ability to consent to molecular analysis study\n* Ability to consent to radiomic\u002F imaging study (as required for international centres)\n\nExclusion Criteria:\n\n* Moderate to advanced stage T3-T4 oropharyngeal SCC\n* TORS performed for diagnostic, recurrent, or palliative intentions.\n* Prior history of head and neck cancer or radiation therapy at any time\n* Known distant metastatic disease.\n* Nasopharyngeal, thyroid, cutaneous, and non-SCC head and neck cancers.","ALL","18 Years",{"count":75,"type":76},250,"ESTIMATED","OBSERVATIONAL","Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).",[80],"Cancer Head Neck",[82,83,84,85,86],"Robotic Surgical Procedures","Margins of Excision","Oropharyngeal neoplasms","Local neoplasm recurrence","Recurrence free survival","2024-08-06",{"date":89,"type":90},"2024-08-07","ACTUAL",{"date":92,"type":90},"2023-12-19",{"date":94,"type":76},"2027-08",{"name":5,"class":6},1]