Use of Axillary Ultrasound to Guide Breast Cancer Management in the Genomic Assay Era
Sponsor
KK Women's and Children's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06038110
Collaborator
(none)
150
1
205
0.7
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
150 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Use of Axillary Ultrasound to Guide Breast Cancer Management in the Genomic Assay Era: A Retrospective Cohort Study
Actual Study Start Date
:
Jan 1, 2007
Anticipated Primary Completion Date
:
Jan 31, 2024
Anticipated Study Completion Date
:
Jan 31, 2024
Outcome Measures
Primary Outcome Measures
- the number of abnormal nodes on ultrasound [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
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
to 100 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
breast cancer patients with T1-3, HR-positive and HER2-negative disease.
-
agedā„ 50 years old
-
had axillary ultrasound prior to operation
-
axillary lymph node dissection
Exclusion Criteria:
-
Patients with neoadjuvant chemotherapy
-
bilateral cancers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | KK Women's and Children's Hospital | Singapore | Singapore |
Sponsors and Collaborators
- KK Women's and Children's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
KK Women's and Children's Hospital
ClinicalTrials.gov Identifier:
NCT06038110
Other Study ID Numbers:
- CIRB Ref:2022/2514
First Posted:
Sep 14, 2023
Last Update Posted:
Sep 14, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No