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NCT02992067 Clinical Trial

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

Breastcancer Clinical Trial

— CK-CEUS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02992067
Other study ID # ZJCH-CK19A
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2015
Est. completion date July 2017

Study information
Verified date September 2019
Source Zhejiang Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 359
Est. completion date July 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Zhejiang Cancer Hospital Hangzhou Zhejiang

Sponsors (2)
Lead Sponsor Collaborator
Zhejiang Cancer Hospital Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The Accuracy of CK19 Combined With Contrast-enhanced Ultrasound (CEUS) Predicting Value on Involved Lymph Node 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 1 year
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