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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03280134
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : June 4, 2019
Information provided by (Responsible Party):
YU Xingfei, Zhejiang Cancer Hospital

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 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.

Condition or disease Intervention/treatment Phase
Lymph Node Metastases Breast Cancer Predictive Cancer Model Procedure: axillary lymph node dissection (ALND) Not Applicable

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 status of non-sentinel lymph node in cT1-2cN0 with 1-2 SLNs involvement breast cancer based on peripheral blood CK19 and contrast-enhanced ultrasound. The investigator previously tested this model comparing with MSKCC model in a same population and confirmed a result of satisfactory low false-negative rate and high AUC. This model had a potential practise value in clinic applying. For further validation, the research group design the CK19B trial to prospectively using this model in decision strategy of whether receiving ALND in 1-2SLNs+ patients. If the model predictive result is negative, the risk of nSLNs involvement is estimated very low and the patients should be avoid ALND, even radiotherapy no matter the surgery is mastectomy or conserving. If the model result is positive, then further ALND or radiotherapy should be accepted by patients to decrease the risk of local and regional recurrent. A prospectively and conditional grouping method is planned for this cohort study. The primary endpoint is disease-free survival (DFS) in two groups, the second primary endpoint is local recurrent rate (LRR) and overall survival (OS).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 388 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study based on prospective cohort method and concerning on the two groups (whether ALND or not) by predictive model nSLN results.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
No Intervention: predictive nSLN-
No further axillary lymph node dissection (ALND)
Active Comparator: predictive nSLN+
axillary lymph node dissection (ALND)
Procedure: axillary lymph node dissection (ALND)
If the patients had predictive nSLN+, need further axillary lymph node dissection.

Primary Outcome Measures :
  1. disease-free survival (DFS) [ Time Frame: 3-year(mid-term) 5-year ]
    The time from enrollment to the first recurrent or metastasis event

Secondary Outcome Measures :
  1. local recurrent rate [ Time Frame: 3-year(mid-term) 5-year ]
    The time from enrollment to the first time of local recurrent event (lymph drainage area recurrence)

  2. overal survival (OS) [ Time Frame: 3-year(mid-term) 5-year ]
    The time from enrollment to death for any reason

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03280134

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Contact: XF YU, M.D. +8657188122001

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China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xing-Fei YU, MD.   
Principal Investigator: Xing-Fei YU, MD.         
Sponsors and Collaborators
Zhejiang Cancer Hospital
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Principal Investigator: XF YU, M.D. Zhejiang Cancer Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: YU Xingfei, Dr., Zhejiang Cancer Hospital Identifier: NCT03280134    
Other Study ID Numbers: ZJCH-CK19B
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by YU Xingfei, Zhejiang Cancer Hospital:
non-sentinel lymph node
breast cancer
contrast-enhanced ultrasound
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes