[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631396":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":10,"responsibleParty":26,"collaborators":10,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":35,"eligibilityCriteria":36,"healthyVolunteers":37,"sex":38,"minAge":39,"maxAge":10,"enrollmentInfo":40,"targetDuration":10,"studyType":43,"phases":10,"briefSummary":44,"conditions":45,"keywords":51,"overallStatus":56,"whyStopped":10,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":10},{"fullName":5,"class":6},"Atlas University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Breast Cancer + NAC Cohort",null,"Patients with histologically confirmed locally advanced breast cancer who are scheduled to receive standard-of-care neoadjuvant chemotherapy. No additional tissue or blood samples will be collected for research purposes; only residual tumor tissue and serum obtained during routine clinical care will be used for exosomal microRNA analysis. Molecular findings will be correlated with pathological complete response (pCR) after treatment.",{"label":13,"type":10,"description":14,"interventionNames":10},"Benign Breast Disease Control Cohort","Patients with histologically confirmed benign breast lesions. No additional tissue or blood samples will be collected for research purposes; only residual tissue and serum obtained during routine diagnostic or therapeutic procedures will be used for exosomal microRNA profiling to serve as a non-malignant control group.",[16],{"name":17,"affiliation":18,"role":19},"EMİNE YILDIRIM","Atlas University Faculty of Medicine","PRINCIPAL_INVESTIGATOR",[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"EMİNE YILDIRIM, MD","CONTACT","+905056234825","opdreyildirim@gmail.com",{"type":19,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Emine YILDIRIM","Associate Professor of Surgery, MD","100631396","tissue--and-serum-derived-exosomal-micrornas-as-predictors-of-neoadjuvant-chemotherapy-response-in-breast-cancer-100631396",false,"NCT07500129","Tissue- and Serum-Derived Exosomal microRNAs as Predictors of Neoadjuvant Chemotherapy Response in Breast Cancer","Clinical and Mechanistic Validation of a Tumor-Derived Extracellular Vesicle-Associated miRNA Signature Predicting Response to Neoadjuvant Chemotherapy in Breast Cancer","ExoTSS-BC","Inclusion Criteria:\n\n* Female patients aged 18 years or older\n* Histologically confirmed locally advanced breast cancer scheduled to receive neoadjuvant chemotherapy\n* Availability of residual tumor tissue and\u002For serum samples obtained during routine clinical care\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Male sex\n* Age under 18 years\n* Prior systemic chemotherapy or radiotherapy administered for the current breast disease before enrollment.\n* Evidence of metastatic disease at diagnosis (for breast cancer cohort)\n* Pregnancy or breastfeeding\n* Any condition that precludes the availability or adequate quality of tissue or blood samples for research purposes",true,"FEMALE","18 Years",{"count":41,"type":42},60,"ESTIMATED","OBSERVATIONAL","This prospective observational study aims to evaluate whether exosomal microRNA profiles derived from tumor tissue and blood serum are associated with pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) in patients with breast cancer.\n\nBreast cancer patients with similar clinical and pathological features may respond differently to treatment, underscoring the need for reliable biomarkers that can help predict therapeutic outcomes. Exosomes are small extracellular vesicles released by tumor cells that carry molecular signals, including microRNAs, which may reflect tumor behavior and treatment sensitivity.\n\nIn this study, patients with breast cancer receiving standard NAC as part of routine clinical care will be followed prospectively. Exosomal microRNA profiles obtained from tumor tissue and blood samples collected during routine diagnostic and treatment procedures will be analyzed and compared with pathological complete response (pCR) assessed after completion of neoadjuvant chemotherapy.\n\nA group of patients with benign breast disease will be included as a reference control for comparative analyses.\n\nThe results of this study may contribute to the identification of minimally invasive biomarkers that support personalized treatment strategies in breast cancer.",[46,47,48,49,50],"Breast Cancer","Invasive Breast Carcinoma","Exosomal microRNA","Neoadjuvant Chemotherapy Response","Pathological Complete Response",[46,52,48,53,54,55,50],"Breast Cancer Biomarkers","Circulating microRNA","Tissue-derived exosomes","Serum-derived exosomes","NOT_YET_RECRUITING","2026-03-24",{"date":59,"type":60},"2026-03-30","ACTUAL",{"date":62,"type":42},"2026-04-12",{"date":64,"type":42},"2027-04-22",{"name":5,"class":6}]