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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

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.

Condition or disease Intervention/treatment
Breast Cancer Sentinel Lymph Node Diagnostic Test: mapping agent Procedure: neoadjuvant chemotherapy

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Study Type : Observational
Estimated Enrollment : 21000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sentinel Lymph Node Biopsy in Early Breast Cancer: a Real-world Multicenter Cross-sectional Study (CABS001 Study)
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
performed SLNB using a single mapping agent 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.

performed SLNB by combination of blue dye and radiotracer 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.

underwent SLN surgery receiving neoadjuvant chemotherapy Procedure: neoadjuvant chemotherapy
Patients were divided into two groups based on whether they were receiving neoadjuvant chemotherapy.

underwent SLN surgery not receiving neoadjuvant chemotherapy Procedure: neoadjuvant chemotherapy
Patients were divided into two groups based on whether they were receiving neoadjuvant chemotherapy.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

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 ClinicalTrials.gov identifier (NCT number): NCT04156841


Contacts
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Contact: Juliang Zhang 029-84775271 ext 13572900544 ycj617655094@163.com

Locations
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China, Shaanxi
Xijing hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Rui Ling    029-84775271    lingruiaoxue@126.com   
Sponsors and Collaborators
Xijing Hospital

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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT04156841     History of Changes
Other Study ID Numbers: KY20192114-C-1
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases