N/A
Completed N=359
CK19 Combined With Contrast-enhanced Ultrasound: a Prediction System on Axillary Lymph Node Metastasis in Breast Cancer
Lymph Node · Breastcancer
Source: ClinicalTrials.gov NCT02992067 ↗
Enrolled (actual)
359
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: The Accuracy of CK19 Combined With Contrast-enhanced Ultrasound (CEUS) Predicting Value on Involved Lymph Node — 0.0896 proportion of false negative lymphnodes
Summary
To establish a predicting system on axillary lymph node metastasis based on peripheral blood CK19mRNA and contrast-enhanced ultrasound.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Accuracy of CK19 Combined With Contrast-enhanced Ultrasound (CEUS) Predicting Value on Involved Lymph Node |
0.0896 | — |
Eligibility Criteria
Inclusion Criteria
- female, age 18~70 years old
- 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
- metastatic breast cancer, inflammatory breast disease, surgery without lymph node staging
- pregnancy or lactation
- patients with hematopoietic system disease or cancer, autoimmune diseases
- preservation of substandard peripheral blood samples.
Data sourced from ClinicalTrials.gov (NCT02992067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.