Status:

UNKNOWN

A Prospective Validation Cohort Study of a Prediction System on nSLN Metastasis in Early Breast Cancer

Lead Sponsor:

Zhejiang Cancer Hospital

Conditions:

Lymph Node Metastases

Breast Cancer

Eligibility:

FEMALE

18-70 years

Phase:

NA

Brief Summary

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...

Detailed Description

In the previous study, a predictive model for non-sentinel lymph node involvement in early breast cancer (cT1-2cN0, 1-2 SLNs involvement) was established. This model was designed for predicting the st...

Eligibility Criteria

Inclusion

  • 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

  • metastatic breast cancer, inflammatory breast disease, surgery without lymph node staging
  • pregnancy or lactation
  • patients with hematopoietic system disease or cancer, autoimmune diseases
  • preservation of substandard peripheral blood samples.

Key Trial Info

Start Date :

October 15 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2020

Estimated Enrollment :

388 Patients enrolled

Trial Details

Trial ID

NCT03280134

Start Date

October 15 2018

End Date

June 1 2020

Last Update

June 4 2019

Active Locations (1)

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022