[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594366":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":29,"responsibleParty":56,"collaborators":58,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":85,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Yunnan Cancer Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Surface Enhanced Raman Spectroscopy (SERS) Detection",null,"Intraoperatively, approximately 5 mm samples of tumor and adjacent normal tissues are collected from breast cancer patients after resection. After lymph nodes dissection, the tissues are bisected longitudinally along the maximum cross-section. The collected tissues are then divided into two portions. One portion is weighed, and tissue lysis buffer (RIPA:PIC:PMSF = 100:1:1) is added at a ratio of 5 μL per 1 mg tissue. The tissue is minced into 1 mm fragments on ice, and 3 mm zirconium beads are added for homogenization based on tissue weight. The homogenate is centrifuged at 12,000 g for 2 min at 4°C. The supernatant (50 μL) is collected for detection, and the remaining tissue is reserved for pathological evaluation.",[13],"Diagnostic Test: SERS detection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","SERS detection","Incubation: A mixture of 20 μL (0.5 mg\u002FmL) magnetic beads (MB@RB20115UD), 40 μL SERS nanotags (Au-IR808@RB20115UC), and prepared sample is incubated for 5 min.\n\nWashing: The supernatant is removed after magnetic separation (30 s), followed by washing with PBST (pH 7.4, 0.05% Tween-20).\n\nDetection: The separated pellet is resuspended in 10 μL ultrapure water. Then 2 μL solution is spotted onto a 2.5 mm × 2.5 mm gold substrate for air-drying. Raman spectra are acquired using a portable spectrometer (785 nm laser, 500 mW power, 5 s acquisition time, triplicate measurements). Peak areas within 540-570 cm-1 are quantified.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Kang-Liang Lou, Doctor","CONTACT","+8615158661275","15158661275@163.com",{"name":27,"role":23,"phone":10,"phoneExt":10,"email":28},"Jing-Wen Bai, Doctor","baijingwen666@126.com",[30],{"facility":5,"status":10,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Kunming","Yunnan","650118","China","CN",{"type":37,"coordinates":38},"Point",[39,40],102.71833,25.03889,{"lat":40,"lon":39},[43,47,49,51,52,53],{"name":44,"role":23,"phone":45,"phoneExt":10,"email":46},"Guo-Jun Zhang, Doctor","+86 0871-68231187","zhangguojun@kmmu.edu.cn",{"name":22,"role":23,"phone":48,"phoneExt":10,"email":25},"8615158661275",{"name":44,"role":50,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":22,"role":50,"phone":10,"phoneExt":10,"email":10},{"name":27,"role":50,"phone":10,"phoneExt":10,"email":10},{"name":54,"role":55,"phone":10,"phoneExt":10,"email":10},"Lei Niu, Master","SUB_INVESTIGATOR",{"type":57,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[59],{"name":60,"class":6},"Xiang'an Hospital of Xiamen University","100594366","epcam-targeted-surface-enhanced-raman-spectroscopy-nanotags-for-rapid-evaluation-of-surgical-margins-and-sentinel-lymph-node-metastasis-status-in-breast-cancers-100594366",false,"NCT07018505","EpCAM-Targeted Surface-Enhanced Raman Spectroscopy Nanotags for Rapid Evaluation of Surgical Margins and Sentinel Lymph Node Metastasis Status in Breast Cancers","Inclusion Criteria:\n\n* Adult patients between 18-75 years of age\n* Female\n* Patients presenting with a breast cancer to be resectable on pre-operative assessment\n* Good operative candidate\n* Subject capable of giving informed consent and participating in the process of consent\n\nExclusion Criteria:\n\n* Patients unable to participate in the consent process\n* Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc\n* Other conditions that the researcher considers inappropriate to participate in the study","FEMALE","18 Years","75 Years",{"count":71,"type":72},40,"ESTIMATED","OBSERVATIONAL","For early breast cancer patients, breast-conserving surgery and sentinel lymph node biopsy have emerged as the cornerstone of precision oncology, harmonizing oncologic efficacy with the preservation of breast cosmetics and axillary function. However, conventional margin evaluation relies on subjective experience, leading to positive margin rates of 15%-50% Additionally, sentinel lymph node biopsy faces inherent technical limitations, including prolonged procedural time and significant false-negative rates in detecting micro-metastases. To overcome these challenges, the investigators will introduce a stable \"sandwich\" EpCAM-targeted surface-enhanced Raman spectroscopy (SERS) detection system to provide rapid evaluation of surgical margins and sentinel lymph node (SLN) metastasis status. In brief, a portion of resected tissue will be immediately homogenized by grinding, and the tissue homogenate will then be analyzed using this detection system to determine its histological characteristics. Pathological confirmation will further validate the method. This approach aims to improve the accuracy and efficiency of intraoperative assessment of breast-conserving surgical margins and SLN status, thereby effectively reducing local recurrence rates and complications.",[76,77,78,79],"Sentinel Lymph Node","Breast Cancers","Metastases","Margin Assessment",[76,81,82,83,84],"Surface Enhanced Raman Spectroscopy","EpCAM","Breast cancers","Surgical margin","NOT_YET_RECRUITING","2025-06-04",{"date":88,"type":89},"2025-06-12","ACTUAL",{"date":91,"type":72},"2025-06-15",{"date":93,"type":72},"2026-07-01",{"name":5,"class":6},1]