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

June 2, 2019 updated by: YU Xingfei, Zhejiang Cancer Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

388

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Xing-Fei YU, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-free survival (DFS)
Time Frame: 3-year(mid-term) 5-year
The time from enrollment to the first recurrent or metastasis event
3-year(mid-term) 5-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3-year(mid-term) 5-year
overal survival (OS)
Time Frame: 3-year(mid-term) 5-year
The time from enrollment to death for any reason
3-year(mid-term) 5-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Investigators

  • Principal Investigator: XF YU, M.D., Zhejiang Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

September 9, 2017

First Submitted That Met QC Criteria

September 9, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

June 2, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJCH-CK19B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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