Breast CancerNCT04156841
Sentinel Lymph Node Biopsy in Early Breast Cancer: a Real-world Multicenter Cross-sectional Study (CABS001 Study)
An observational study of Breast Cancer and Sentinel Lymph Node, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Sentinel Lymph Node
- What is being tested?
- mapping agent and neoadjuvant chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 21,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: early breast cancer patients who underwent SLNB in 40 Grade III Level A hospitals in China in 2018
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing hospital
Xi'an, Shaanxi, 710032
Rui Ling, 029-84775271, lingruiaoxue@126.com
About this study
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.
- Conditions
- Breast Cancer, Sentinel Lymph Node
- Being tested
- mapping agent, neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mapping agentDiagnostic test
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.
neoadjuvant chemotherapyProcedure or surgery
Patients were divided into two groups based on whether they were receiving neoadjuvant chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| performed SLNB using a single mapping agent | Not described Receives: Diagnostic Test: mapping agent | |
| performed SLNB by combination of blue dye and radiotracer | Not described Receives: Diagnostic Test: mapping agent | |
| underwent SLN surgery receiving neoadjuvant chemotherapy | Not described Receives: Procedure: neoadjuvant chemotherapy | |
| underwent SLN surgery not receiving neoadjuvant chemotherapy | Not described Receives: Procedure: neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the performance rate of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer in China
the performance rate of SLNB refers to the number of patients implementing SLNB divided by the total number of breast cancer patients
Measured: 2020-12-31
the positive rate of SLNs in patients with early stage breast cancer in China
SLNs positive rate is the number of positive SLN patients divided by the number of patients implementing SLNB
Measured: 2020-12-31
the number of resected SLNs in patients with early stage breast cancer in China
the average number of resected SLNB will be calculated
Measured: 2020-12-31
Secondary outcomes (1)
incidence of infection events after SLNB in patients with early stage breast cancer in China
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.
Measured: 2021-12-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156841
- Sponsor's protocol ID
- KY20192114-C-1
- Status last verified
- Sep 2019
- First submitted
- 29 Sep 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Biopsy in Early Breast Cancer: a Real-world Multicenter Cross-sectional Study (CABS001 Study)
- ClinicalTrials.gov ID
- NCT04156841
- Acronym / sponsor ID
- KY20192114-C-1
- Conditions
- Breast Cancer, Sentinel Lymph Node
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| performed SLNB using a single mapping agent | – | Diagnostic Test: mapping agent |
| performed SLNB by combination of blue dye and radiotracer | – | Diagnostic Test: mapping agent |
| underwent SLN surgery receiving neoadjuvant chemotherapy | – | Procedure: neoadjuvant chemotherapy |
| underwent SLN surgery not receiving neoadjuvant chemotherapy | – | Procedure: neoadjuvant chemotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- early breast cancer patients who underwent SLNB in 40 Grade III Level A hospitals in China in 2018
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mapping agentaccording 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. | Diagnostic test | performed SLNB by combination of blue dye and radiotracer, performed SLNB using a single mapping agent |
| neoadjuvant chemotherapyPatients were divided into two groups based on whether they were receiving neoadjuvant chemotherapy. | Procedure or surgery | underwent SLN surgery not receiving neoadjuvant chemotherapy, underwent SLN surgery receiving neoadjuvant chemotherapy |
Primary outcome
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
1 secondary outcome
incidence of infection events after SLNB in patients with early stage breast cancer in China
Time frame: 2021-12-31
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Sentinel Lymph Node, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliang Zhang (029-84775271 ext. 13572900544, ycj617655094@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the performance rate of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer in China (time frame: 2020-12-31). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.