Breast Cancer FemaleNCT03878017
A Novel Method of Clipped Axillary Lymph Node Localization Post Neoadjuvant Chemotherapy in Breast Cancer Patients .
A study testing skin marking of clip axillary lymph node for localisation in people with Breast Cancer Female, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
to determine the feasibility of a novel technique of localization of clipped LN post neoadjuvant chemotherapy Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- skin marking of clip axillary lymph node for localisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Mar 2017to 30 Oct 2020
- 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 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer patients with involved axillary LN <3,
- going for neoadjuvant chemotherapy
Who cannot join
- -stage 4 breast cancer patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a Novel Method of Axilla Staging by Using Ultrasound Visible Clips to Mark the Involved Axillary Lymph Nodes Before Neoadjuvant Chemotherapy in Breast Cancer Patients
to determine the feasibility of a novel technique of localization of clipped LN post neoadjuvant chemotherapy
- Conditions
- Breast Cancer Female
- Being tested
- skin marking of clip axillary lymph node for localisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin marking of clip axillary lymph node for localisationProcedure or surgery
to determine the feasibility of skin marking to localize clipped ln
| Study group | Role | What they receive |
|---|---|---|
| skin marking of clipped axillary LN | Experimental | all eligible patients underwent skin marking of their clipped axillary LN post neoadjuvant chemotherapy to determine the retrieval rate of the clipped nodes Receives: Procedure: skin marking of clip axillary lymph node for localisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
retrieval rates of the clipped node using this novel technique
Measured: at an average of a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Mar 2017
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Oct 2020 (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 Cancer FemaleStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lim Geok Hoon, KK Women's and Children's Hospital
- Investigators
- Geok H Lim, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878017
- Sponsor's protocol ID
- 2017/2037
- Status last verified
- Feb 2020
- First submitted
- 14 Mar 2019
- Last updated
- 21 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lim GH, Al Shukairi AM, Lee YS, Teo SY, Yan Z, Tan QT, Gudi M, Ng RP, Wong FY. Targeted axillary dissection in breast cancer patients with metastatic nodal disease: a prospective study on localization techniques and oncological outcomes. Gland Surg. 2025 Aug 31;14(8):1529-1538. doi: 10.21037/gs-2025-166. Epub 2025 Aug 20.
PubMed 40948928
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Novel Method of Axilla Staging by Using Ultrasound Visible Clips to Mark the Involved Axillary Lymph Nodes Before Neoadjuvant Chemotherapy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03878017
- Acronym / sponsor ID
- 2017/2037
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 18 Mar 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.
to determine the feasibility of a novel technique of localization of clipped LN post neoadjuvant chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| skin marking of clipped axillary LN | Experimental | Procedure: skin marking of clip axillary lymph node for localisationall eligible patients underwent skin marking of their clipped axillary LN post neoadjuvant chemotherapy to determine the retrieval rate of the clipped nodes |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- breast cancer patients with involved axillary LN <3,
- going for neoadjuvant chemotherapy
Key exclusion criteria (1 listed)
- -stage 4 breast cancer 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 |
|---|---|---|
| skin marking of clip axillary lymph node for localisationto determine the feasibility of skin marking to localize clipped ln | Procedure or surgery | skin marking of clipped axillary LN |
Primary outcome
retrieval rates of the clipped node using this novel technique
Time frame: at an average of a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Derived from this study: PubMed 40948928Lim GH, Al Shukairi AM, Lee YS, Teo SY, Yan Z, Tan QT, Gudi M, Ng RP, Wong FY. Targeted axillary dissection in breast cancer patients with metastatic nodal disease: a prospective study on localization techniques and oncological outcomes. Gland Surg. 2025 Aug 31;14(8):1529-1538. doi: 10.21037/gs-2025-166. Epub 2025 Aug 20.
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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.
Geok H Lim principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin marking of clip axillary lymph node for localisation in people with Breast Cancer Female, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 2 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 21 Feb 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 Singapore. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retrieval rates of the clipped node using this novel technique (time frame: at an average of a 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 NCT03878017, 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 21 Feb 2020.