Trial Outcomes & Findings for CK19 Combined With Contrast-enhanced Ultrasound: a Prediction System on Axillary Lymph Node Metastasis in Breast Cancer (NCT NCT02992067)

NCT ID: NCT02992067

Last Updated: 2019-10-04

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 359 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2019-10-04

Participant Flow

Participant milestones

Measure	Operable Breast Cancer clinical stage: cTis, cI, cII, cT3N1M0
Overall Study STARTED	359
Overall Study COMPLETED	359
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Operable Breast Cancer n=359 Participants clinical stage: cTis, cI, cII, cT3N1M0
Age, Continuous	50.88 years STANDARD_DEVIATION 9.59 • n=5 Participants
Sex: Female, Male Female	359 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	359 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment China	359 Participants n=5 Participants
Lymph node involvement	359 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

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

Outcome measures

Measure	Operable Breast Cancer n=359 Participants clinical stage: cTis, cI, cII, cT3N1M0
The Accuracy of CK19 Combined With Contrast-enhanced Ultrasound (CEUS) Predicting Value on Involved Lymph Node	0.0896 proportion of false negative lymphnodes

Adverse Events

Operable Breast Cancer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yu Xingfei

Zhejiang Cancer Hospital

Phone: 057188122001

Email: yuxf1177@zjcc.org.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place