[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630075":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":156,"collaborators":18,"id":158,"slug":159,"hasResults":160,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":18,"eligibilityCriteria":164,"healthyVolunteers":160,"sex":165,"minAge":166,"maxAge":18,"enrollmentInfo":167,"targetDuration":18,"studyType":170,"phases":171,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":187,"whyStopped":18,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},{"fullName":5,"class":6},"University Hospital Augsburg","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group (LC-OCT)","EXPERIMENTAL","Preoperative tumour margin assessment using LC-OCT with targeted extension of resection margins in cases where imaging reveals tumour evidence.",[13],"Diagnostic Test: Margin Mapping with Line-field confocal optical coherence tomography",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group (standard MMS)","NO_INTERVENTION","Conventional clinical\u002Fdermatoscopic margin determination, as is customary in everyday clinical practice.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIAGNOSTIC_TEST","Margin Mapping with Line-field confocal optical coherence tomography","Both groups undergo micrographically controlled excision (Mohs surgery) in accordance with standard procedure.\n\nSurgical margins are examined histopathologically as usual (e.g. Tübingen cake, Munich method). If tumour remnants are detected, re-excision (MMS cycle) is performed until the tumour is completely removed (R0). The difference in the intervention group is that they will receive preoperative (and if available) postoperative margin mapping of the BCC before surgery.",[9],[26],{"name":27,"affiliation":5,"role":28},"Julia Welzel, MD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","00498214007401","julia.welzel@uk-augsburg.de",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Sandra Schuh, MD, M.Sc.","0049821400167508","sandra.schuh@uk-augsburg.de",[39,69,86,107,139],{"facility":5,"status":18,"city":40,"state":18,"zip":18,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Augsburg","Germany","DE",{"type":44,"coordinates":45},"Point",[46,47],10.89851,48.37154,{"lat":47,"lon":46},[50,51,52,53,55,57,59,61,63,65,67],{"name":27,"role":31,"phone":18,"phoneExt":18,"email":33},{"name":35,"role":31,"phone":18,"phoneExt":18,"email":37},{"name":27,"role":28,"phone":18,"phoneExt":18,"email":18},{"name":35,"role":54,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":56,"role":54,"phone":18,"phoneExt":18,"email":18},"Deborah Winkler, MD",{"name":58,"role":54,"phone":18,"phoneExt":18,"email":18},"Janis Thamm, MD",{"name":60,"role":54,"phone":18,"phoneExt":18,"email":18},"Hanna Wirsching, MD",{"name":62,"role":54,"phone":18,"phoneExt":18,"email":18},"Pelinsu Yilmaz, MD",{"name":64,"role":54,"phone":18,"phoneExt":18,"email":18},"Franziska Reisch, MD",{"name":66,"role":54,"phone":18,"phoneExt":18,"email":18},"Sophia Schlingmann, MD",{"name":68,"role":54,"phone":18,"phoneExt":18,"email":18},"Oliver Mayer, MD",{"facility":70,"status":18,"city":71,"state":18,"zip":18,"country":41,"countryCode":42,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"University Hospital Dresden","Dresden",{"type":44,"coordinates":73},[74,75],13.73832,51.05089,{"lat":75,"lon":74},[78,81,84,85],{"name":79,"role":31,"phone":18,"phoneExt":18,"email":80},"Sarah Hobelsberger, MD","sarah.hobelsberger@ukdd.de",{"name":82,"role":31,"phone":18,"phoneExt":18,"email":83},"Frank F Gellrich, MD","FrankFriedrich.Gellrich@ukdd.de",{"name":79,"role":28,"phone":18,"phoneExt":18,"email":18},{"name":82,"role":54,"phone":18,"phoneExt":18,"email":18},{"facility":87,"status":18,"city":88,"state":18,"zip":18,"country":41,"countryCode":42,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"University Hospital Erlangen","Erlangen",{"type":44,"coordinates":90},[91,92],11.00783,49.59099,{"lat":92,"lon":91},[95,98,101,102,103,105],{"name":96,"role":31,"phone":18,"phoneExt":18,"email":97},"Carola Berking, MD","carola.berking@uk-erlangen.de",{"name":99,"role":31,"phone":18,"phoneExt":18,"email":100},"Moritz Ronicke, MD","moritz.ronicke@uk-erlangen.de",{"name":96,"role":28,"phone":18,"phoneExt":18,"email":18},{"name":99,"role":54,"phone":18,"phoneExt":18,"email":18},{"name":104,"role":54,"phone":18,"phoneExt":18,"email":18},"Leonie Staats, MD",{"name":106,"role":54,"phone":18,"phoneExt":18,"email":18},"Michael Höner, MD",{"facility":108,"status":18,"city":109,"state":18,"zip":18,"country":41,"countryCode":42,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Ludwig Maximilian University Hospital","Munich",{"type":44,"coordinates":111},[112,113],11.57549,48.13743,{"lat":113,"lon":112},[116,119,122,124,125,127,129,131,133,135,137],{"name":117,"role":31,"phone":18,"phoneExt":18,"email":118},"Elke C Sattler, MD","elke.sattler@med.uni-muenchen.de",{"name":120,"role":31,"phone":18,"phoneExt":18,"email":121},"Charlotte Gust, MD","charlotte.gust@med.uni-muenchen.de",{"name":123,"role":28,"phone":18,"phoneExt":18,"email":18},"Elke Sattler, MD",{"name":120,"role":54,"phone":18,"phoneExt":18,"email":18},{"name":126,"role":54,"phone":18,"phoneExt":18,"email":18},"Quirine Eijkenboom, MD",{"name":128,"role":54,"phone":18,"phoneExt":18,"email":18},"Benedikt Reiner, MD",{"name":130,"role":54,"phone":18,"phoneExt":18,"email":18},"Surina Frey, MD",{"name":132,"role":54,"phone":18,"phoneExt":18,"email":18},"Nina Janjic, MD",{"name":134,"role":54,"phone":18,"phoneExt":18,"email":18},"Martin Flatz, MD",{"name":136,"role":54,"phone":18,"phoneExt":18,"email":18},"Lea Jakob, MD",{"name":138,"role":54,"phone":18,"phoneExt":18,"email":18},"Stephanie Steckmeier, MD",{"facility":140,"status":18,"city":109,"state":18,"zip":18,"country":41,"countryCode":42,"cosmosGeoPoint":141,"geoPoint":143,"contacts":144},"München Klinik",{"type":44,"coordinates":142},[112,113],{"lat":113,"lon":112},[145,148,151,153,154],{"name":146,"role":31,"phone":18,"phoneExt":18,"email":147},"Daniela Hartmann, MD, PhD","daniela.hartmann@muenchen-klinik.de",{"name":149,"role":31,"phone":18,"phoneExt":18,"email":150},"Maximilian Deußing, MD","maximilian.deussing@muenchen-klinik.de",{"name":152,"role":28,"phone":18,"phoneExt":18,"email":18},"Daniela Hartmann, MD",{"name":149,"role":54,"phone":18,"phoneExt":18,"email":18},{"name":155,"role":54,"phone":18,"phoneExt":18,"email":18},"Fabia Daxenberger, MD",{"type":157,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100630075","bcc-one-stop-study-100630075",false,"NCT07482956","BCC-One-Stop-Study","Multicentre, Interventional Prospective Study to Evaluate the Efficiency of Pre- and Postoperative Margin Determination of Basal Cell Carcinomas Using Optical Coherence Tomography and Line-field Confocal Optical Coherence Tomography During Micrographically Controlled Surgery","Inclusion Criteria:\n\n* Adults (≥18 years) with basal cell carcinoma (BCC) scheduled for Mohs micrographic surgery (MMS),\n* Diagnosis confirmed by dermoscopy and histopathology or optical coherence tomography (OCT),\n* No limitation regarding tumor size or BCC subgroups.\n\nExclusion Criteria:\n\n* Poor LC-OCT image quality,\n* Incomplete adherence to the study protocol,\n* Previous treatment of the BCC,\n* Anatomical sites that are difficult to access with LC-OCT (e.g., inner ear, medial canthus of the eye).","ALL","18 Years",{"count":168,"type":169},290,"ESTIMATED","INTERVENTIONAL",[172],"NA","Basal cell carcinoma (BCC) is the most common malignant skin tumour. The standard treatment is micrographically controlled surgery (MMS), which achieves high cure rates but requires considerable time and personnel. A key problem is the inadequate preoperative determination of tumour margins, which often leads to multiple cycles of excision.\n\nThe aim of this multicentre, prospective, randomised controlled intervention study is to evaluate line-field confocal optical coherence tomography (LC-OCT) for preoperative margin determination in BCC within the framework of MMS.\n\nResearch question:\n\nCan preoperative LC-OCT-assisted margin marking increase the efficiency of MMS by reducing the number of excision cycles required without compromising oncological safety?\n\nMethodology:\n\nApproximately 290 patients with histologically confirmed BCC will be enrolled at five German centres and randomly assigned to either standard MMS or MMS with upstream LC-OCT margin determination. In the intervention group, the excision margin will be specifically extended if a tumour is detected in the LC-OCT.\n\nPrimary endpoint:\n\nNumber of MMS cycles required to achieve R0 resection.\n\nSecondary endpoints:\n\nTotal duration of surgery, size of surgical defect, cosmetic outcome (POSAS), patient satisfaction and stress, sensitivity and specificity of LC-OCT compared to histopathology.\n\nSignificance:\n\nThe study addresses the clinical conflict of objectives between complete tumour removal and maximum tissue preservation. Successful implementation could optimise MMS through modern imaging, conserve surgical resources and improve patient care in the long term.",[175],"Basal Cell Carcinoma",[177,178,179,180,181,182,183,184,185,186],"basal cell carcinoma","line-field confocal optical coherence tomography","BCC","LC-OCT","Mohs micrographic surgery","MMS","margin mapping","margin assessment","skin cancer","one stop shop","NOT_YET_RECRUITING","2026-03-16",{"date":190,"type":191},"2026-03-19","ACTUAL",{"date":193,"type":169},"2026-04-01",{"date":195,"type":169},"2027-12-31",{"name":5,"class":6},5]