Axillary UltrasoundNCT06038110
Use of Axillary Ultrasound to Guide Breast Cancer Management in the Genomic Assay Era
An observational study of Axillary Ultrasound, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 years, women only
- Conditions the study is for
- Axillary Ultrasound
- What is being tested?
- axillary ultrasound
- How many people
- 150 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2007to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- Women only
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- Patients with neoadjuvant chemotherapy
- bilateral cancers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Axillary Ultrasound
- Being tested
- axillary ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axillary ultrasoundDiagnostic test
usefulness of axillary ultrasound in predicting need for chemotherapy or upfront surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from the date of diagnosis to the date of surgery, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Jan 2007
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axillary UltrasoundStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038110
- Sponsor's protocol ID
- CIRB Ref:2022/2514
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Axillary Ultrasound to Guide Breast Cancer Management in the Genomic Assay Era: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06038110
- Acronym / sponsor ID
- CIRB Ref:2022/2514
- Conditions
- Axillary Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with neoadjuvant chemotherapy
- bilateral cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| axillary ultrasoundusefulness of axillary ultrasound in predicting need for chemotherapy or upfront surgery | Diagnostic test | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
Related trials for Axillary Ultrasound
RecruitingObservational study
Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
Breast Cancer, Axillary Lymph Nodes Dissection
Not yet recruiting
Effect of Serratus and Pectoralis II Plane Block Versus Pectoralis II Alone on Acute Postoperative Pain After Mastectomy
Mastectomy, Mastectomy Plus Axillary Lymph Node Dissection
Recruiting
Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer
Breast Carcinoma, Breast Cancer
RecruitingPhase 2
IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases
Breast Cancer, Axillary Nodal Disease
RecruitingEarly Phase 1
3D Ultrasound for the Imaging of Lymph Nodes in Patients With Breast Cancer
Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axillary Ultrasound, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of abnormal nodes on ultrasound (time frame: from the date of diagnosis to the date of surgery, up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.