Breastcancer, Lymph Node
Conditions
Keywords
lymph node metastasis, breast cancer, CK19, contrast-enhanced ultrasonography
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.
Interventions
None listed
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Zhejiang Cancer Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Accuracy of CK19 Combined With Contrast-enhanced Ultrasound (CEUS) Predicting Value on Involved Lymph Node | 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 |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Operable Breast Cancer clinical stage: cTis, cI, cII, cT3N1M0 | 359 |
| Total | 359 |
Baseline characteristics
| Characteristic | Operable Breast Cancer |
|---|---|
| Age, Continuous | 50.88 years STANDARD_DEVIATION 9.59 |
| Lymph node involvement | 359 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 359 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China | 359 Participants |
| Sex: Female, Male Female | 359 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 359 |
| other Total, other adverse events | 0 / 359 |
| serious Total, serious adverse events | 0 / 359 |
Outcome results
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
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Operable Breast Cancer | The Accuracy of CK19 Combined With Contrast-enhanced Ultrasound (CEUS) Predicting Value on Involved Lymph Node | 0.0896 proportion of false negative lymphnodes |