[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04603209":3,"trial-entities:NCT04603209":94,"trial-summary:NCT04603209":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":38,"secondary_outcomes":43,"sex":50,"minimum_age":51,"maximum_age":27,"healthy_volunteers":15,"eligibility_criteria":52,"std_ages":62,"locations":65,"central_contacts":86,"overall_officials":89,"references":92,"see_also_links":93},"NCT04603209","STUDY2019000317","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","RECRUITING","2028-10-03","2024-04","2024-04-16","2018-10-03","Saint John's Cancer Institute","OTHER",false,"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.","At Providence Saint John's Health Center, there is the ongoing integration of Intra-Operative Radiation Therapy (IORT) as a standard treatment option among Breast Conserving Therapy (BCT) for individuals with in situ and early stage breast cancer. Currently, approximately 60 women per year are being treated with IORT. No repository of information of patient outcomes with this treatment has been established. This leaves a critical gap in the ability to assess the long-term outcomes of patients treated with IORT.\n\nAs the practice of using IORT to treat early stage and in situ breast cancer continues to grow at Providence Saint John's Health Center, this registry will provide the data needed to compare patient outcomes with those being treated with the traditional whole breast radiation therapy. In addition, the Providence Health \\& Services strives to improve patient care and outcomes with excellence whenever possible. The registry will provide the data needed to compare patient outcomes to national and community standards that can inform internal practice patterns and contribute to advancing breast cancer care nationally and internationally.",[19,20,21],"Early-stage Breast Cancer","Breast Carcinoma in Situ","Breast Neoplasms",[23,19,24,25],"Breast Cancer","Intraoperative Radiotherapy","IORT","OBSERVATIONAL",null,[],{"count":30,"type":31},1000,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"RADIATION","Intraoperative Radiation Therapy (IORT)","IORT involving 50kV Xrays to a dose of 20 Gy during breast-conserving surgery",[25],[39],{"measure":40,"description":41,"timeFrame":42},"Disease Recurrence","Presence of recurrent tumor in ipsilateral breast or distant site","5 years",[44,48],{"measure":45,"description":46,"timeFrame":47},"Disease specific survival","survival","10 years",{"measure":49,"description":46,"timeFrame":47},"Overall Survival","ALL","18 Years",{"inclusion":53,"exclusion":58,"raw_text":61},[54,55,56,57],"Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification)","Unifocal Disease","Candidate for breast-conserving surgery","Recommended treatment by multidisciplinary team",[59,60],"Clinical stage T3-4, N1-3, M1","Multifocal disease","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",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":67,"status":8,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":83},"John Wayne Cancer Institute, Providence Saint John's Health Center","Santa Monica","California","90404","United States",[73,78,81],{"name":74,"role":75,"phone":76,"email":77},"Janie Grumley, MD","CONTACT","310-582-7100","janie.grumley@providence.org",{"name":79,"role":80},"Robert Wollman, MD","SUB_INVESTIGATOR",{"name":82,"role":80},"Lisa Chaiken, MD",{"lat":84,"lon":85},34.01949,-118.49138,[87],{"name":74,"role":75,"phone":88,"email":77},"(310) 582-7100",[90],{"name":74,"affiliation":67,"role":91},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":95,"biomarkers":97},[96],"Breast Carcinoma",[],{"nct_id":4,"found":99,"summary":100,"prompt_version":110},true,{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is an observational study, meaning researchers will collect information about your treatment and health outcomes. It plans to include 1000 participants.","completed","Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery","This study is a registry for women with early-stage breast cancer who are receiving Intraoperative Radiation Therapy (IORT) during breast-conserving surgery. IORT involves a single dose of radiation (50kV X-rays to a dose of 20 Gy) given during surgery. The purpose is to track the long-term effects of this treatment, including any complications, if the cancer comes back (recurrence), and how long patients live without the disease or overall. You might be able to join if you have early-stage breast cancer (Tis, T1, or T2, N0, M0), the cancer is in one spot (unifocal), and your medical team recommends breast-conserving surgery. The study aims to see how effective and safe IORT is over time, with success measured by whether the disease recurs after 5 years. The current recruitment status is unclear.","Your health will be tracked to see if the disease recurs, with measurements taken at 5 years.",131,"Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]