CK19 Combined With Contrast-enhanced Ultrasound: a Prediction System on Axillary Lymph Node Metastasis in Breast Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

359 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To establish a predicting system on axillary lymph node metastasis based on peripheral blood CK19mRNA and contrast-enhanced ultrasound.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound

NCT02992769

Breast Cancer Female

UNKNOWN

Prediction of Axillary Lymph Node Metastasis Status in Breast Cancer Based on PET/CT Radiomics

NCT05826197

Breast Neoplasms

UNKNOWN

Serum and Tissue Metabolite-based Prediction of Sentinel Lymph Node Metastasis in Breast Cancer

NCT06001528

Breast Cancer Lymph Node Metastasis

RECRUITING

The Value of High-resolution Ultrasound in the Detection of Lymph Node Metastasis: a Proposal of NI-RADS

NCT03791840

Breast Neoplasms

COMPLETED

Ultrasound Radiomics for Predicting Breast Cancer and Axillary Lymph Node Metastasis

NCT05768451

Breast Cancer Axillary Lymph Node Metastasis

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The feasibility and predictive accuracy of peripheral blood CK19mRNA and contrast-enhanced ultrasound of axillary lymph nodes metastasis in breast cancer were verified by the data of specimen bank; to establish the evaluation system of predicting the lymph node status based on CK19 and CEUS, validate the sensitivity, specificity, negative predictive value, positive predictive value and ROC curve of the system model and use Youden index, negative likelihood ratio, positive likelihood ratio to evaluate the diagnostic efficiency.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymph Node Breastcancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Operable breast cancer

clinical stage: cTis, cI, cII, cT3N1M0

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No