[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"axillary-lymph-node-metastasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:axillary-lymph-node-metastasis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100616386","a-prospective-multicenter-study-of-the-tufest-ln-model-for-axillary-lymph-node-status-assessment-in-breast-cancer-100616386",false,"NCT07304934","A Prospective Multicenter Study of the TuFEst-LN Model for Axillary Lymph Node Status Assessment in Breast Cancer","A Prospective Multi-center Cohort Study Based on Deep Learning-based cfDNA Fragment Omics to Verify the TuFEst Model for Axillary Lymph Node Status Assessment in Breast Cancer Patients Undergoing Primary Surgery or Neoadjuvant Therapy","PRO-TuFEst-LN","Cohort 1-Specific Inclusion Criteria\n\nParticipants in Cohort 1 must meet all of the following criteria:\n\n1. Histologically confirmed invasive breast cancer.\n2. Clinical stage cT1-3, cN0, M0 disease at enrollment.\n3. No clinically palpable suspicious metastatic axillary lymph nodes identified by physical examination.\n4. No radiologically suspicious metastatic axillary lymph nodes identified by preoperative axillary imaging (at least ultrasound examination). Patients with suspicious lymph nodes must have negative cytological or histological findings confirmed by fine-needle aspiration or core needle biopsy.\n5. No prior neoadjuvant therapy, including chemotherapy, targeted therapy, immunotherapy, endocrine therapy, or breast\u002Faxillary radiotherapy before enrollment.\n6. Planned to undergo definitive breast surgery with sentinel lymph node biopsy (SLNB) and\u002For axillary lymph node dissection (ALND).\n7. Ability to provide qualified preoperative plasma samples for cfDNA analysis.\n\nCohort 2-Specific Inclusion Criteria\n\nParticipants in Cohort 2 must meet all of the following criteria:\n\n1. Histologically confirmed invasive breast cancer.\n2. Ipsilateral axillary lymph node metastasis confirmed by fine-needle aspiration or core needle biopsy at initial diagnosis.\n3. No evidence of distant metastasis (M0), and planned to receive standard neoadjuvant systemic therapy followed by definitive breast and axillary surgery.\n4. Completion of the planned neoadjuvant therapy, or premature discontinuation due to clinical reasons while remaining eligible for subsequent surgery.\n5. Ability to provide a baseline plasma sample (T0) within 24-72 hours before initiation of the first systemic treatment (including chemotherapy, immunotherapy, or targeted therapy).\n6. Availability of preoperative breast and axillary magnetic resonance imaging (MRI) after completion of neoadjuvant therapy. Patients unable to undergo MRI due to contraindications or other reasons may be included in the cfDNA-only analysis set but will not be included in the complete-case analysis of the combined cfDNA-MRI model.\n7. Ability to provide a second plasma sample (T1) within 24-72 hours before surgery after completion of neoadjuvant therapy. Patients without T0 samples may still be included in the exploratory analysis of T1 cfDNA combined with MRI for ypN prediction.\n8. Availability of complete postoperative breast and axillary pathological evaluation results.\n\nExclusion Criteria\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Pregnancy or breastfeeding.\n2. Prior surgical removal of the primary breast lesion before enrollment, resulting in inability to obtain the required preoperative blood samples.\n3. Presence of confirmed distant metastasis.\n4. Presence of supraclavicular, internal mammary, or other lymph node lesions that cannot be adequately assessed by planned surgery and pathological evaluation.\n5. History of another active malignancy within the previous 5 years, except for cured non-melanoma skin cancer, cervical carcinoma in situ, or other malignancies considered by investigators unlikely to affect study outcomes.\n6. Receipt of whole blood, plasma, or other blood product transfusion within 30 days prior to enrollment.\n7. Insufficient plasma sample volume, severe hemolysis, or failure to meet cfDNA sequencing quality control requirements determined by the central laboratory.\n8. Absence of evaluable axillary surgical pathological results.\n9. Any other condition considered by the investigator to make the patient unsuitable for participation in this study.","FEMALE","18 Years",{"count":20,"type":21},400,"ESTIMATED","1 Year","OBSERVATIONAL","Through the research of this project, we expect to validate the clinical utility of the TuFEst-LN model in assessing axillary lymph node status in breast cancer patients. Specifically, we aim to prospectively validate its ability to identify pathologically node-negative patients among clinically and radiologically assessed cN0 patients undergoing upfront surgery ，and explore the predictive value of the TuFEst-LN model combined with preoperative MRI for ypN status assessment in initially node-positive patients following neoadjuvant therapy.",[26,27],"Breast Cancer","Axillary Lymph Node Metastasis",[29,30,31,32,33,34,35,36,37,38],"breast cancer","cfDNA","TuFEst model","Fragmentomics","Axillary lymph node","Sentinel lymph node biopsy","Neoadjuvant therapy","Magnetic resonance imaging","Diagnostic accuracy","Machine learning","RECRUITING","2026-08-05",{"date":42,"type":43},"2026-08-10","ACTUAL",{"date":45,"type":43},"2025-08-01",{"date":47,"type":21},"2027-12-31",{"name":49,"class":50},"Second Affiliated Hospital, Zhejiang University, School of Medicine","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":51},"100639879","ultrasound-monitoring-of-clipped-lymph-nodes-to-predict-axillary-response-after-chemotherapy-in-breast-cancer-100639879","NCT07596472","Ultrasound Monitoring of Clipped Lymph Nodes to Predict Axillary Response After Chemotherapy in Breast Cancer","A Prospective Diagnostic Clinical Study Based on Longitudinal Multimodal Ultrasound Evaluation of Clipped Lymph Nodes to Assess Axillary Pathological Response After Neoadjuvant Chemotherapy in Breast Cancer","Inclusion Criteria:\n\n* Female patients aged 18 years or older.\n\nClinical stage of breast cancer: T1-T4, N1-N3, M0.\n\nAxillary lymph node metastasis confirmed by fine-needle aspiration (FNA) or core-needle biopsy.\n\nIndicated for and planned to receive standard neoadjuvant chemotherapy (NAC) regimen.\n\nThe biopsy-proven metastatic lymph node is clearly visible on ultrasound and suitable for clip placement.\n\nCompletion of NAC followed by breast surgery and axillary lymph node dissection, with complete pathological results available.\n\nUnderwent multimodal ultrasound monitoring during NAC, including conventional ultrasound, elastography, and contrast-enhanced ultrasound.\n\nSigned informed consent and willingness to complete all scheduled follow-ups.\n\nExclusion Criteria:\n\n* Bilateral breast cancer.\n\nPatients who are not suitable for neoadjuvant chemotherapy or plan to receive endocrine or targeted therapy only.\n\nPrior breast or axillary surgery, chemotherapy, or other treatments that may affect the current therapeutic assessment.\n\nPresence of distant metastasis or extensive axillary invasion making clip placement or evaluation difficult.\n\nPregnant or lactating women.\n\nPoor image quality on ultrasound or other imaging modalities.\n\nInability to provide informed consent due to psychological, family, or social factors",{"count":60,"type":21},150,"This study aims to evaluate whether longitudinal multimodal ultrasound can accurately predict axillary pathological response in breast cancer patients who receive neoadjuvant chemotherapy. In this study, patients with biopsy-proven metastatic axillary lymph nodes will have a metallic clip placed in the positive node before chemotherapy. During and after treatment, the clipped lymph node will be monitored by ultrasound, including gray-scale imaging, shear wave elastography, and contrast-enhanced ultrasound. The changes in the morphological and functional features of the clipped node will be analyzed to establish a predictive model for axillary pathological complete response. The results are expected to help identify patients who may safely avoid unnecessary axillary lymph node dissection and improve individualized surgical decision-making.",[26,27,63,64],"Neoadjuvant Chemotherapy","Pathological Complete Response","NOT_YET_RECRUITING","2026-05-13",{"date":68,"type":43},"2026-05-19",{"date":70,"type":21},"2026-05-20",{"date":72,"type":21},"2027-05-20",{"name":74,"class":50},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"]