Breast Cancer Clinical Trial
Official title:
CK19 Combined With Contrast-enhanced Ultrasound for Predicting Non-sentinel Lymph Node Status in Early Breast Cancer: a Prospectively Validation Cohort Study of the Predictive Model
NCT number | NCT03280134 |
Other study ID # | ZJCH-CK19B |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 15, 2018 |
Est. completion date | June 2020 |
In the previous study, the investigator established a predictive model for non-sentinel lymph node involvement in early breast cancer (cT1-2cN0, 1-2 SLNs involvement). To validation the clinical value of the model, the investigator design a prospectively research using the model guiding for further axillary lymph node dissection in SLN-positve early breast cancer.
Status | Recruiting |
Enrollment | 388 |
Est. completion date | June 2020 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Zhejiang Cancer Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | disease-free survival (DFS) | The time from enrollment to the first recurrent or metastasis event | 3-year(mid-term) 5-year | |
Secondary | local recurrent rate | The time from enrollment to the first time of local recurrent event (lymph drainage area recurrence) | 3-year(mid-term) 5-year | |
Secondary | overal survival (OS) | The time from enrollment to death for any reason | 3-year(mid-term) 5-year |
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