[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100408802":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":30,"responsibleParty":52,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":10,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":10,"enrollmentInfo":64,"targetDuration":67,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Saint John's Cancer Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IORT",null,"All participants who plan to undergo partial mastectomy for treatment of early stage breast cancer will be considered for eligibility for IORT. Patient with single breast cancer less than 3cm in disease span, clinical negative axillary node will be offered the option of having IORT. If IORT is delivered following surgical resection of the tumor they will be followed in this registry for short and long term outcomes.",[13],"Radiation: Intraoperative Radiation Therapy (IORT)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"RADIATION","Intraoperative Radiation Therapy (IORT)","IORT involving 50kV Xrays to a dose of 20 Gy during breast-conserving surgery",[9],[21],{"name":22,"affiliation":23,"role":24},"Janie Grumley, MD","John Wayne Cancer Institute, Providence Saint John's Health Center","PRINCIPAL_INVESTIGATOR",[26],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","(310) 582-7100","janie.grumley@providence.org",[31],{"facility":23,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Santa Monica","California","90404","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-118.49138,34.01949,{"lat":42,"lon":41},[45,47,50],{"name":22,"role":27,"phone":46,"phoneExt":10,"email":29},"310-582-7100",{"name":48,"role":49,"phone":10,"phoneExt":10,"email":10},"Robert Wollman, MD","SUB_INVESTIGATOR",{"name":51,"role":49,"phone":10,"phoneExt":10,"email":10},"Lisa Chaiken, MD",{"type":24,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Janie Grumley","Director of the Comprehensive Breast Program, Margie Petersen Breast Center","100408802","registry-for-intra-operative-radiotherapy-during-breast-conserving-surgery-in-patients-with-early-stage-breast-cancer-100408802",false,"NCT04603209","Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer","Research Registry for Intra-Operative Radiotherapy (IORT) During Breast Conserving Surgery in Patients With in Situ and Early Stage Breast Cancer","Inclusion Criteria:\n\n* Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification)\n* Unifocal Disease\n* Candidate for breast-conserving surgery\n* Recommended treatment by multidisciplinary team\n\nExclusion Criteria:\n\n* Clinical stage T3-4, N1-3, M1\n* Multifocal disease","ALL","18 Years",{"count":65,"type":66},1000,"ESTIMATED","5 Years","OBSERVATIONAL","This is a prospective, registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy (IORT) during breast-conserving surgery. The purpose of this study is to further validate the long-term effectiveness and safety of this treatment method. We aim to assess short and long-term patient outcomes associated with IORT, including perioperative complications, local and distance disease recurrences, as well as disease-free survival and overall survival.",[71,72,73],"Early-stage Breast Cancer","Breast Carcinoma in Situ","Breast Neoplasms",[75,71,76,9],"Breast Cancer","Intraoperative Radiotherapy","2024-04-15",{"date":79,"type":80},"2024-04-16","ACTUAL",{"date":82,"type":80},"2018-10-03",{"date":84,"type":66},"2028-10-03",{"name":5,"class":6},1]