- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06038110
Use of Axillary Ultrasound to Guide Breast Cancer Management in the Genomic Assay Era
September 12, 2023 updated by: KK Women's and Children's Hospital
Use of Axillary Ultrasound to Guide Breast Cancer Management in the Genomic Assay Era: A Retrospective Cohort Study
The investigators aimed to determine if axillary ultrasound can reliably distinguish between patients with limited or high nodal burden, so that the patients with limited nodal burden can potentially avoid chemotherapy and instead receive upfront surgery followed by gene assay testing.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
150
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
-
-
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Singapore, Singapore
- KK Women's and Children's Hospital
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Breast cancer patients with T1-3, HR-positive and HER2-negative disease, aged≥ 50 years old, had axillary ultrasound prior to operation and axillary lymph node dissection
Description
Inclusion Criteria:
- breast cancer patients with T1-3, HR-positive and HER2-negative disease.
- aged≥ 50 years old
- had axillary ultrasound prior to operation
- axillary lymph node dissection
Exclusion Criteria:
- Patients with neoadjuvant chemotherapy
- bilateral cancers
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the number of abnormal nodes on ultrasound
Time Frame: from the date of diagnosis to the date of surgery, up to 12 weeks
|
the number of abnormal nodes on ultrasound which was done at the time of diagnosis will be measured
|
from the date of diagnosis to the date of surgery, up to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 1, 2007
Primary Completion (Estimated)
January 31, 2024
Study Completion (Estimated)
January 31, 2024
Study Registration Dates
First Submitted
September 6, 2023
First Submitted That Met QC Criteria
September 12, 2023
First Posted (Actual)
September 14, 2023
Study Record Updates
Last Update Posted (Actual)
September 14, 2023
Last Update Submitted That Met QC Criteria
September 12, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- CIRB Ref:2022/2514
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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