NCT06038110

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
16.7 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

17.1 years

First QC Date

September 6, 2023

Last Update Submit

September 12, 2023

Conditions

Axillary Ultrasound

Outcome Measures

Primary Outcomes (1)

  • the number of abnormal nodes on ultrasound

    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

Interventions

axillary ultrasoundDIAGNOSTIC_TEST

usefulness of axillary ultrasound in predicting need for chemotherapy or upfront surgery

Eligibility Criteria

Age21 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • Patients with neoadjuvant chemotherapy
  • bilateral cancers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 14, 2023

Study Start

January 1, 2007

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

SG(1)