Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-02-12 @ 6:05 PM
Study NCT ID:
NCT02992067
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2016-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CK19 Combined With Contrast-enhanced Ultrasound: a Prediction System on Axillary Lymph Node Metastasis in Breast Cancer
Sponsor:
Zhejiang Cancer Hospital
Organization:
Study Overview
Official Title:
CK19 Combined With Contrast-enhanced Ultrasound: a Prediction System on Axillary Lymph Node Metastasis in Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CK-CEUS
Brief Summary:
To establish a predicting system on axillary lymph node metastasis based on peripheral blood CK19mRNA and contrast-enhanced ultrasound.
Detailed 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: