NCT03878017

Brief Summary

to determine the feasibility of a novel technique of localization of clipped LN post neoadjuvant chemotherapy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

3.7 years

First QC Date

March 14, 2019

Last Update Submit

February 19, 2020

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

  • retrieval rates of the clipped node using this novel technique

    at an average of a year

Study Arms (1)

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

Procedure: skin marking of clip axillary lymph node for localisation

Interventions

skin marking of clip axillary lymph node for localisationPROCEDURE

to determine the feasibility of skin marking to localize clipped ln

skin marking of clipped axillary LN

Eligibility Criteria

Age21 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • breast cancer patients with involved axillary LN \<3,
  • going for neoadjuvant chemotherapy

You may not qualify if:

  • stage 4 breast cancer patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 40948928DERIVED

Study Officials

  • Geok H Lim

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 18, 2019

Study Start

March 1, 2017

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

February 21, 2020

Record last verified: 2020-02

Locations

SG(1)