Back to resultsA Novel Method of Clipped Axillary Lymph Node Localization Post Neoadjuvant Chemotherapy in Breast Cancer Patients .
Primary Purpose
Breast Cancer Female
Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
skin marking of clip axillary lymph node for localisation
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Female
Eligibility Criteria
Inclusion Criteria:
- breast cancer patients with involved axillary LN <3,
- going for neoadjuvant chemotherapy
Exclusion Criteria:
-stage 4 breast cancer patients
Sites / Locations
- KK Women's and Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
skin marking of clipped axillary LN
Arm Description
all eligible patients underwent skin marking of their clipped axillary LN post neoadjuvant chemotherapy to determine the retrieval rate of the clipped nodes
Outcomes
Primary Outcome Measures
retrieval rates of the clipped node using this novel technique
Secondary Outcome Measures
Full Information
NCT ID
NCT03878017
First Posted
March 14, 2019
Last Updated
February 19, 2020
Sponsor
KK Women's and Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03878017
Brief Title
A Novel Method of Clipped Axillary Lymph Node Localization Post Neoadjuvant Chemotherapy in Breast Cancer Patients .
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
October 30, 2020 (Anticipated)
Study Completion Date
October 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KK Women's and Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
to determine the feasibility of a novel technique of localization of clipped LN post neoadjuvant chemotherapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
skin marking of clipped axillary LN
Arm Type
Experimental
Arm Description
all eligible patients underwent skin marking of their clipped axillary LN post neoadjuvant chemotherapy to determine the retrieval rate of the clipped nodes
Intervention Type
Procedure
Intervention Name(s)
skin marking of clip axillary lymph node for localisation
Intervention Description
to determine the feasibility of skin marking to localize clipped ln
Primary Outcome Measure Information:
Title
retrieval rates of the clipped node using this novel technique
Time Frame
at an average of a year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
breast cancer patients with involved axillary LN <3,
going for neoadjuvant chemotherapy
Exclusion Criteria:
-stage 4 breast cancer patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geok H Lim
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
Country
Singapore
12. IPD Sharing Statement
Learn more about this trial
A Novel Method of Clipped Axillary Lymph Node Localization Post Neoadjuvant Chemotherapy in Breast Cancer Patients .
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