A Novel Method of Clipped Axillary Lymph Node Localization Post Neoadjuvant Chemotherapy in Breast Cancer Patients .

February 19, 2020 updated by: Lim Geok Hoon, KK Women's and Children's Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • KK Women's and Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

-stage 4 breast cancer patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: skin marking of clipped axillary LN
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
to determine the feasibility of skin marking to localize clipped ln

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
retrieval rates of the clipped node using this novel technique
Time Frame: at an average of a year
at an average of a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Investigators

  • Principal Investigator: Geok H Lim, KK Women's and Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Anticipated)

October 30, 2020

Study Completion (Anticipated)

October 30, 2020

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/2037

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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