[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565897":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":36,"studyPopulation":37,"armGroups":32,"interventions":32,"overallOfficials":38,"centralContacts":42,"locations":47,"responsibleParty":63,"collaborators":65,"id":70,"slug":32,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":32,"eligibilityCriteria":74,"healthyVolunteers":71,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":32,"studyType":81,"phases":32,"briefSummary":82,"conditions":83,"keywords":32,"overallStatus":49,"whyStopped":32,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Institute of Oncology Ljubljana","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":32},[9,13,15,17],{"measure":10,"description":11,"timeFrame":12},"Adverse events of radiation therapy","We will assess the proportion of patients exhibiting skin and cardiac adverse events after radiotherapy using Common Terminology Criteria for Adverse Events, NYHA class, measurement of cardiac biomarkers and cardiac imaging","Within 1 month after completion of radiotherapy",{"measure":10,"description":11,"timeFrame":14},"6 months after radiotherapy",{"measure":10,"description":11,"timeFrame":16},"2 years after radiotherapy",{"measure":10,"description":11,"timeFrame":18},"5 years after radiotherapy",[20,23,25,28,30,31],{"measure":21,"description":22,"timeFrame":18},"Disease recurrence","We will assess the proportion of patients with disease recurrence.",{"measure":21,"description":22,"timeFrame":24},"10 years after radiotherapy",{"measure":26,"description":27,"timeFrame":12},"Changes of circulating biomarkers","We will assess the changes of circulating biomarkers (miRNA, extracellular vesicles, proteins) after radiotherapy compared to values before radiotherapy.",{"measure":26,"description":27,"timeFrame":29},"6 months after radiotherapy,",{"measure":26,"description":27,"timeFrame":16},{"measure":26,"description":27,"timeFrame":18},null,{"allocation":32,"interventionModel":32,"interventionModelDescription":32,"primaryPurpose":32,"observationalModel":34,"timePerspective":35,"maskingInfo":32},"COHORT","PROSPECTIVE","Monocentric prospective clinical study including DCIS patients treated at the Institute of Oncology Ljubljana. Patients treated with adjuvant radiotherapy and without systemic therapy are eligible for the study.\n\nAdverse events of radiation treatment will be assessed after radiotherapy and during 5-year follow up and classified according to Common Terminology Criteria for Adverse Events v5.0.\n\nMolecular biomarkers will be assessed before radiotherapy, after radiotherapy and during follow up. DNA will be isolated from whole blood samples obtained before radiation treatment. Circulating biomarkers will be isolated from plasma samples before treatment, after treatment and during follow-up. Written informed consent will be obtained from all included patients and the study design was approved by the National Medical Ethics Committee.","Breast cancer patients with non invasive ductal carcinoma in situ (DCIS) with an indication for postoperative radiation treatment.",[39],{"name":40,"affiliation":5,"role":41},"Tanja Marinko, MD, PhD","PRINCIPAL_INVESTIGATOR",[43],{"name":40,"role":44,"phone":45,"phoneExt":32,"email":46},"CONTACT","0038615879505","tmarinko@onko-i.si",[48],{"facility":5,"status":49,"city":50,"state":32,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Ljubljana","1000","Slovenia","SI",{"type":55,"coordinates":56},"Point",[57,58],14.50513,46.05108,{"lat":58,"lon":57},[61,62],{"name":40,"role":44,"phone":45,"phoneExt":32,"email":46},{"name":40,"role":41,"phone":32,"phoneExt":32,"email":32},{"type":64,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[66,68],{"name":67,"class":6},"University of Ljubljana, Faculty of Medicine",{"name":69,"class":6},"University Medical Centre Ljubljana","100565897",false,"NCT06648148","Molecular Biomarkers of Response to Radiation Therapy in Breast Cancer","Inclusion Criteria:\n\n* Breast cancer patients with DCIS with an indication for adjuvant radiation therapy\n\nExclusion Criteria:\n\n* Any specific systemic oncological therapy","FEMALE","18 Years","75 Years",{"count":79,"type":80},200,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to identify potential genetic and other molecular biomarkers of response to radiation therapy in breast cancer that may help to personalize breast cancer radiation treatment in the future.",[84,85],"Breast Cancer","Radiotherapy Side Effect","2024-10-16",{"date":88,"type":89},"2024-10-18","ACTUAL",{"date":91,"type":89},"2019-11-01",{"date":93,"type":80},"2029-12-31",{"name":5,"class":6},1]