[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508359":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":50,"centralContacts":59,"locations":68,"responsibleParty":88,"collaborators":36,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":100,"minAge":101,"maxAge":36,"enrollmentInfo":102,"targetDuration":36,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":36,"overallStatus":71,"whyStopped":36,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"University Hospital Augsburg","OTHER",[8,17,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"BC, mastectomy and implant","EXPERIMENTAL","Women with first diagnosis of breast cancer or DCIS and planned skin-sparing mastectomy and implant placement",[13,14,15,16],"Procedure: Swap collection","Procedure: Seroma punction","Procedure: Blood sampling","Diagnostic Test: Sonographic correlation Seroma",{"label":18,"type":19,"description":20,"interventionNames":21},"BC and mastectomy","ACTIVE_COMPARATOR","Women with first diagnosis of breast cancer or DCIS and planned simple mastectomy",[13,14,15,16],{"label":23,"type":19,"description":24,"interventionNames":25},"High risk for BC","healthy women with high risk for breast cancer and planned bilateral risk-reducing mastectomy and implant reconstruction",[13,14,15,16],{"label":27,"type":19,"description":28,"interventionNames":29},"Cosmetic breast surgery","healthy women planned for plastic breast implant surgery",[13,14,15,16],[31,37,41,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"PROCEDURE","Swap collection","Performing the surgery (Mastectomy with or without implant reconstruction; Insertion of Breast implants for control group 3) according to valid standards.\n\nIn addition, taking swabs intraoperatively according to protocol from skin and surgical site.",[18,9,27,23],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Seroma punction","Puncturing of a seroma in case of occurence and clinical need",[18,9,27,23],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Blood sampling","Blood sampling at defined time points according to protocol",[18,9,27,23],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":36},"DIAGNOSTIC_TEST","Sonographic correlation Seroma","If a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma",[18,9,27,23],[51,55],{"name":52,"affiliation":53,"role":54},"Thorsten Kühn, Prof.","Eubreast Network, Baumreute 37 D-73730 Esslingen, Germany","STUDY_CHAIR",{"name":56,"affiliation":57,"role":58},"Nina Ditsch, Prof.","University Hospital Augsburg, Stenglinstr. 2, D-86156 Augsburg, Germany","PRINCIPAL_INVESTIGATOR",[60,64],{"name":56,"role":61,"phone":62,"phoneExt":36,"email":63},"CONTACT","+49 (0)821 400 165809","nina.ditsch@uk-augsburg.de",{"name":65,"role":61,"phone":66,"phoneExt":36,"email":67},"Melitta Köpke, Dr. med.","+49 (0)821 400 165862","melitta.koepke@uk-augsburg.de",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"University Hospital Augsburg, Department of Gynecology and Obstetrics","RECRUITING","Augsburg","Bavaria","86156","Germany","DE",{"type":78,"coordinates":79},"Point",[80,81],10.89851,48.37154,{"lat":81,"lon":80},[84,86],{"name":56,"role":61,"phone":36,"phoneExt":36,"email":85},"nina.ditsch@uk-agsburg.de",{"name":87,"role":61,"phone":36,"phoneExt":36,"email":67},"Melitta Köpke, Dr.",{"type":58,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Nina Ditsch","Prof. Dr. med.","100508359","seroma-of-the-mammary-gland-100508359",false,"NCT05899387","Seroma of the Mammary Gland","Prospective, International, Multicenter Minimal Interventional Study to Detect Possible Markers for Prediction of Seroma Development and Risk Assessment of a Breast Seroma After Mastectomy with or Without Implant-based Breast Reconstruction","SerMa","Inclusion criteria study group and control group 1:\n\n* Written informed consent\n* Age ≥ 18 years\n* all stages of DCIS or primary breast cancer (T1-T4, N0 or N+, M0) including all histopathological subtypes (ER\u002FPR positive, ER positive\u002FPR negative, Her-2\u002Fneu positive and triple negative)\n* Surgical procedure planned including ablatio or subcutaneous mastectomy with implant or expander insertion\n\nInclusion criteria control group 2 and 3:\n\n* Written informed consent\n* Age ≥ 18 years\n* Surgical procedure planned with implant or expander insertion with or without subcutaneous mastectomy\n\nExclusion criteria:\n\n* Age \\\u003C18 years\n* Male sex\n* Breast cancer patients planned for breast conserving therapy\n* Recurrent breast cancer disease\n* History of breast surgery\n* Diagnosis of LCIS only\n* Pregnancy at time of diagnosis\n* Patients with a known immunodeficiency",true,"FEMALE","18 Years",{"count":103,"type":104},2000,"ESTIMATED","INTERVENTIONAL",[107],"NA","The study is designed as international, prospective, minimal interventional study in cooperation with EUBREAST e.V. (European Breast Cancer Research Association of Surgical Trialists). Furthermore, it is planned to initiate a registry for postoperative breast seromas.",[110,111,112,113],"Seroma","Breast Cancer","Mastectomy","Breast Implant; Complications","2025-02-25",{"date":116,"type":117},"2025-02-28","ACTUAL",{"date":119,"type":117},"2024-04-01",{"date":121,"type":104},"2027-07-01",{"name":5,"class":6},1]