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Sentinel Lymph Node Biopsy in Early Breast Cancer: a Real-world Multicenter Cross-sectional Study (CABS001 Study)

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ClinicalTrials.gov Identifier: NCT04156841
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Tracking Information
First Submitted Date September 29, 2019
First Posted Date November 8, 2019
Last Update Posted Date November 8, 2019
Actual Study Start Date August 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2019)
  • the performance rate of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer in China [ Time Frame: 2020-12-31 ]
    the performance rate of SLNB refers to the number of patients implementing SLNB divided by the total number of breast cancer patients
  • the positive rate of SLNs in patients with early stage breast cancer in China [ Time Frame: 2020-12-31 ]
    SLNs positive rate is the number of positive SLN patients divided by the number of patients implementing SLNB
  • the number of resected SLNs in patients with early stage breast cancer in China [ Time Frame: 2020-12-31 ]
    the average number of resected SLNB will be calculated
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 5, 2019)
incidence of infection events after SLNB in patients with early stage breast cancer in China [ Time Frame: 2021-12-31 ]
incidence of infection events is the number of patients who have an infection event after SLNB divided by the total number of patients implementing SLNB. The infection events include incision infection, local skin infection and injured vascular infection.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sentinel Lymph Node Biopsy in Early Breast Cancer: a Real-world Multicenter Cross-sectional Study (CABS001 Study)
Official Title Sentinel Lymph Node Biopsy in Early Breast Cancer: a Real-world Multicenter Cross-sectional Study (CABS001 Study)
Brief Summary Objective: To investigate the current clinical practice of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer in China. Methods: The data of early breast cancer patients who underwent SLNB in 40 Grade III Level A hospitals in China in 2018 will be collected. Different centers, tracer methods, molecular typing and neoadjuvant chemotherapy will be used as stratification factors to analyze the implementation rate, number of detections, positive rate of SLNB and the follow-up treatment.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population early breast cancer patients who underwent SLNB in 40 Grade III Level A hospitals in China in 2018
Condition
  • Breast Cancer
  • Sentinel Lymph Node
Intervention
  • Diagnostic Test: mapping agent
    according to different tracer methods, patients are divided into the implementation of a single mapping agent and implementation of combination of blue dye and radiotracer agent.
  • Procedure: neoadjuvant chemotherapy
    Patients were divided into two groups based on whether they were receiving neoadjuvant chemotherapy.
Study Groups/Cohorts
  • performed SLNB using a single mapping agent
    Intervention: Diagnostic Test: mapping agent
  • performed SLNB by combination of blue dye and radiotracer
    Intervention: Diagnostic Test: mapping agent
  • underwent SLN surgery receiving neoadjuvant chemotherapy
    Intervention: Procedure: neoadjuvant chemotherapy
  • underwent SLN surgery not receiving neoadjuvant chemotherapy
    Intervention: Procedure: neoadjuvant chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 5, 2019)
21000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • breast cancer confirmed by fine needle aspiration or biopsy
  • SLNB with or without axillary lymph node dissection
  • receiving conventional systematic treatment or regional treatment
  • complete medical record.

Exclusion Criteria:

  • IV stage breast cancer
  • combined with secondary invasive malignant tumor
  • diagnosed with other serious disease, including congestive heart failure (NYHA cardiac function grade II, III, IV) or congestive heart failure, unstable angina pectoris, myocardial infarction, high-risk uncontrollable heart rate disorder or other serious cardiovascular diseases within 6 months
  • difficulty breathing at rest or need oxygen therapy
  • severe infection
  • uncontrolled diabetes
  • serious psychological or mental disorders
  • poor compliance.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Juliang Zhang 029-84775271 ext 13572900544 ycj617655094@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04156841
Other Study ID Numbers KY20192114-C-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Xijing Hospital
Study Sponsor Xijing Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Xijing Hospital
Verification Date September 2019