Clinical trial · Interventional
A Prospective Validation Cohort Study of a Prediction System on nSLN Metastasis in Early Breast Cancer
CK19 Combined With Contrast-enhanced Ultrasound for Predicting Non-sentinel Lymph Node Status in Early Breast Cancer: a Prospectively Validation Cohort Study of the Predictive Model
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In the previous study, the investigator established a predictive model for non-sentinel lymph node involvement in early breast cancer (cT1-2cN0, 1-2 SLNs involvement). To validation the clinical value of the model, the investigator design a prospectively research using the model guiding for further axillary lymph node dissection in SLN-positve early breast cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymph Node Metastases | — | UNRESOLVED | — |
| Predictive Cancer Model | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| axillary lymph node dissection (ALND) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- predictive nSLN-
- description
- No further axillary lymph node dissection (ALND)
- type
- ACTIVE_COMPARATOR
- label
- predictive nSLN+
- description
- axillary lymph node dissection (ALND)
- interventionNames
- Procedure: axillary lymph node dissection (ALND)
Primary outcomes (1)
- measure
- disease-free survival (DFS)
- timeFrame
- 3-year(mid-term) 5-year
- description
- The time from enrollment to the first recurrent or metastasis event
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: the test group should be in accordance with the pathological diagnosis of breast cancer, the clinical stage of breast cancer (stage cTis, cI, cII and cT3N1M0), the initial treatment to receive surgical treatment. Complete preoperative clinical diagnosis data, including the ipsilateral axillary lymph node CEUS data and peripheral blood sample; The negative-control group should comply with the pathological diagnosis, breast adenosis, fibrocystic lesions, breast cysts and other benign lesions, with complete preoperative clinical data, also including ipsilateral axillary lymph node CEUS data and peripheral blood sample Exclusion Criteria: 1. metastatic breast cancer, inflammatory breast disease, surgery without lymph node staging 2. pregnancy or lactation 3. patients with hematopoietic system disease or cancer, autoimmune diseases 4. preservation of substandard peripheral blood samples.
References
Publications (1)
- DERIVEDQiao E, Yu X, Zhou L, Wang C, Yang C, Yu Y, Chen D, Huang J, Yang H. A Prospective Validation Cohort Study of a Prediction Model on Non-sentinel Lymph Node Involvement in Early Breast Cancer. Ann Surg Oncol. 2020 May;27(5):1653-1658. doi: 10.1245/s10434-019-07980-x. Epub 2019 Oct 28. PMID 31659631