Use of Axillary Ultrasound to Guide Breast Cancer Managem... | NCT06038110

Studies
Use of Axillary Ultrasound to Guide Breast Cancer Management in the Genomic Assay Era

NCT06038110

Sponsor

KK Women's and Children's Hospital

Status

Unknown status

Last Update Posted

Sep 14, 2023Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Axillary Ultrasound

Interventions

axillary ultrasound

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2007Actual

Primary Completion Date

Jan 31, 2024Estimated

Completion Date

Jan 31, 2024Estimated

First Submitted Date

Sep 6, 2023

First Submission Date that Met QC Criteria

Sep 12, 2023

First Posted Date

Sep 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2023

Last Update Posted Date

Sep 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
axillary ultrasound	Diagnostic Test	usefulness of axillary ultrasound in predicting need for chemotherapy or upfront surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KK Women's and Children's Hospital		Singapore			Singapore