Breast CancerNCT04568941
Comparison Study of Different Tumor Biopsy Method for Sentinel Lymph Node Biopsy in Breast Cancer
A study testing Vacuum-Assisted Biopsy, Core Needle Biopsy and Intraoperative Excisional Biopsy in people with Breast Cancer and Sentinel Lymph Node, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cance, and the identified number of sentinel lymph nodes determines its accuracy for axillary status. Retrospective study indicated that preoperative tumor biopsy results in more detected sentinel lymoh nodes. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Sentinel Lymph Node
- What is being tested?
- Vacuum-Assisted Biopsy, Core Needle Biopsy and Intraoperative Excisional Biopsy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 1 Jun 2021
- Phase
- Interventional
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinically lymph node negative breast cancer patients T1-T3
Who cannot join
- history of breast cancer locally advanced breast cancer and metastatic breast cancer proven axillary lymph node metastasis history of axillary excisional or incisional biopsy, or dissection history of neoadjuvant chemotherapy pregnancy non-consented patients
Trial locations and contacts
1 site in 1 country.
China1 site
Zhiyong Yu
Jinan, Shandong
Zhiyong Yu, PhD, 86053167626958 ext. 86053167626958, drzhiyongyu@aliyun.com
Chao Li, MD, 86053167626958 ext. 86053167626958, lichao19890305@126.com
About this study
Official title: Randomized Controlled Trial of Comparison of Tumor Biopsy Method of Preoperative Vacuum-Assisted, Core Needle Versus Intraoperative Excisional Biopsy for Sentinel Lymph Node Biopsy in Breast Cancer
Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cance, and the identified number of sentinel lymph nodes determines its accuracy for axillary status. Retrospective study indicated that preoperative tumor biopsy results in more detected sentinel lymoh nodes. The clinical trail is designed to compare the effect of three tumor biopsy methods (preoperative vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy) for sentinel lymph nodes.
Read the detailed description
OBJECTIVES:
Compare the identification rate of sentinel lymph node in breast cancer patients with different tumor biopsy methods.
Evaluate the false-negative rates of sentinel lymph nodes in patients with different tumor biopsy methods.
OUTLINE:
The patients were randomly divided into three group, vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy. Preoperative vacuum-assisted biopsy and core needle biopsy were performed in 10 days before the final surgery. All patients received dual tracer (radiolabeled colloid and blue dye) guided SLNB.
- Conditions
- Breast Cancer, Sentinel Lymph Node
- Being tested
- Vacuum-Assisted Biopsy, Core Needle Biopsy, Intraoperative Excisional Biopsy
- Keywords
- Sentinel Lymph Node, vacuum-assisted biopsy, Core needle biopsy, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum-Assisted BiopsyBehavioural
Vacuum-Assisted Biopsy
Core Needle BiopsyBehavioural
Core Needle Biopsy
Intraoperative Excisional BiopsyBehavioural
Intraoperative Excisional Biopsy
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Vacuum-Assisted Biopsy | Experimental | Preoperative vacuum-assisted biopsy was performed within 10 days before final surgery. The tumor were excised almost. Receives: Behavioral: Vacuum-Assisted Biopsy |
| Preoperative Core Needle Biopsy | Experimental | Preoperative core needle biopsy was performed within 10 days before final surgery. The needle biopsy were performed with 3 needles. Receives: Behavioral: Core Needle Biopsy |
| Intraoperative Excisional Biopsy | Experimental | The tumor was excised intraoperatively. Receives: Behavioral: Intraoperative Excisional Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification rates of sentinel lymph node biopsy
Identification rate of SLNB between three groups
Measured: 1 year
Secondary outcomes (2)
Identification numbers of sentinel lymph node biopsy
Identification numbers of SLNB between three groups
Measured: 1 year
fase-negative rates of sentinel lymph node biopsy
fase-negative rates of SLNB between three groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyong Yu, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568941
- Sponsor's protocol ID
- ShandongCHI-13
- Status last verified
- Oct 2020
- First submitted
- 26 Sep 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yuan C, Wang X, Liu Z, Li C, Bian M, Shan J, Song X, Yu Z, Yu J. Preoperative tumor biopsy results in more detected sentinel nodes than intraoperative biopsy in breast cancer patients. World J Surg Oncol. 2020 Jul 21;18(1):178. doi: 10.1186/s12957-020-01942-4.
PubMed 32693797
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Comparison of Tumor Biopsy Method of Preoperative Vacuum-Assisted, Core Needle Versus Intraoperative Excisional Biopsy for Sentinel Lymph Node Biopsy in Breast Cancer
- ClinicalTrials.gov ID
- NCT04568941
- Acronym / sponsor ID
- ShandongCHI-13
- Conditions
- Breast Cancer, Sentinel Lymph Node
- Keywords
- Sentinel Lymph Node, vacuum-assisted biopsy, Core needle biopsy, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 29 Sep 2020 (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.
Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cance, and the identified number of sentinel lymph nodes determines its accuracy for axillary status. Retrospective study indicated that preoperative tumor biopsy results in more detected sentinel lymoh nodes. The clinical trail is designed to compare the effect of three tumor biopsy methods (preoperative vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy) for sentinel lymph nodes.
Detailed description
OBJECTIVES:
Compare the identification rate of sentinel lymph node in breast cancer patients with different tumor biopsy methods.
Evaluate the false-negative rates of sentinel lymph nodes in patients with different tumor biopsy methods.
OUTLINE:
The patients were randomly divided into three group, vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy. Preoperative vacuum-assisted biopsy and core needle biopsy were performed in 10 days before the final surgery. All patients received dual tracer (radiolabeled colloid and blue dye) guided SLNB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preoperative Vacuum-Assisted Biopsy | Experimental | Behavioral: Vacuum-Assisted BiopsyPreoperative vacuum-assisted biopsy was performed within 10 days before final surgery. The tumor were excised almost. |
| Preoperative Core Needle Biopsy | Experimental | Behavioral: Core Needle BiopsyPreoperative core needle biopsy was performed within 10 days before final surgery. The needle biopsy were performed with 3 needles. |
| Intraoperative Excisional Biopsy | Experimental | Behavioral: Intraoperative Excisional BiopsyThe tumor was excised intraoperatively. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinically lymph node negative breast cancer patients T1-T3
Key exclusion criteria (1 listed)
- history of breast cancer locally advanced breast cancer and metastatic breast cancer proven axillary lymph node metastasis history of axillary excisional or incisional biopsy, or dissection history of neoadjuvant chemotherapy pregnancy non-consented patients
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 |
|---|---|---|
| Vacuum-Assisted BiopsyVacuum-Assisted Biopsy | Behavioural | Preoperative Vacuum-Assisted Biopsy |
| Core Needle BiopsyCore Needle Biopsy | Behavioural | Preoperative Core Needle Biopsy |
| Intraoperative Excisional BiopsyIntraoperative Excisional Biopsy | Behavioural | Intraoperative Excisional Biopsy |
Primary outcome
Identification rates of sentinel lymph node biopsy
Time frame: 1 year
Identification rate of SLNB between three groups
2 secondary outcomes
Identification numbers of sentinel lymph node biopsy
Time frame: 1 year
fase-negative rates of sentinel lymph node biopsy
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Results publication: PubMed 32693797Yuan C, Wang X, Liu Z, Li C, Bian M, Shan J, Song X, Yu Z, Yu J. Preoperative tumor biopsy results in more detected sentinel nodes than intraoperative biopsy in breast cancer patients. World J Surg Oncol. 2020 Jul 21;18(1):178. doi: 10.1186/s12957-020-01942-4.
- Related InfoLink provided by the sponsor.
- 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?
A study testing Vacuum-Assisted Biopsy, Core Needle Biopsy and Intraoperative Excisional Biopsy in people with Breast Cancer and Sentinel Lymph Node, run by Shandong Cancer Hospital and Institute 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 1 inclusion and 1 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 27 Oct 2020. 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 Zhiyong Yu, PhD (86-13355312277, drzhiyongyu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification rates of sentinel lymph node biopsy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04568941, which also lists 1 linked publication.
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 27 Oct 2020.