- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03878017
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
- 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
|
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.
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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