Clinical trial · Observational
CK19 Combined With Contrast-enhanced Ultrasound: a Prediction System on Axillary Lymph Node Metastasis in Breast Cancer
NCT02992067CI-TRIAL-00041010CK-CEUScompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
To establish a predicting system on axillary lymph node metastasis based on peripheral blood CK19mRNA and contrast-enhanced ultrasound.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breastcancer | — | UNRESOLVED | — |
| Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Operable breast cancer
- description
- clinical stage: cTis, cI, cII, cT3N1M0
Primary outcomes (1)
- measure
- The Accuracy of CK19 Combined With Contrast-enhanced Ultrasound (CEUS) Predicting Value on Involved Lymph Node
- timeFrame
- 1 year
- description
- The accuracy means the conformity of predicting results and the pathological result in lymph node involvement and also the false negative rate of sentinel lymph node (SLN) and non-SLN (nSLN) using prediction model by CK19 combined with CEUS examination
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. female, age 18\~70 years old 2. 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