Breast DiseaseNCT04571307
Cryotherapy in Breast B3 Lesions
A study testing cryotherapy in people with Breast Disease and Phyllodes Breast Tumor, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
To determine the feasibility of cryotherapy for B3 fibroepithelial lesions Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Breast Disease, Phyllodes Breast Tumor
- What is being tested?
- cryotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Sep 2021to 15 Oct 2022
- Phase
- Interventional
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lesion seen on ultrasound
- core biopsy revealed FEL of B3
- lesion </+3.5cm
- keen for cryotherapy instead of surgery
- has other breast lesions for followup
Who cannot join
- cancer patients
- patients with bleeding diathesis
- lesions causing visible breast deformity
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore
Geok H Lim, +6596392353 ext. +6596392353, lim.gh@singhealth.com.sg
About this study
Official title: Pilot Study on the Feasibility of Cryotherapy as an Alternative Treatment for Phyllodes Tumors/Breast Fibroepithelial Lesions (FELs) Needing Surgery
To determine the feasibility of cryotherapy for B3 fibroepithelial lesions
- Conditions
- Breast Disease, Phyllodes Breast Tumor
- Being tested
- cryotherapy
- Medical subject headings
- Breast Diseases, Phyllodes Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapyProcedure or surgery
comparison between cryotherapy and surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of the lesion
assessed on ultrasound
Measured: 2 years from procedure
breast cosmetic outcome
patient self assessment of excellent (1), good (2), fair (3) poor (4). score of 1-4,1 being the best score
Measured: at 1 year post procedure
pain score
using pain score scale of 0-10, a higher score indicates a worse outcome
Measured: immediate post procedure
pain score
using pain score scale of 0-10, a higher score indicates a worse outcome
Measured: at 2 weeks post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start15 Sep 2021 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Geok hoon lim, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571307
- Sponsor's protocol ID
- 2019/2944
- Status last verified
- Aug 2021
- First submitted
- 31 Aug 2020
- Last updated
- 5 Sep 2021
- 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 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Feasibility of Cryotherapy as an Alternative Treatment for Phyllodes Tumors/Breast Fibroepithelial Lesions (FELs) Needing Surgery
- ClinicalTrials.gov ID
- NCT04571307
- Acronym / sponsor ID
- 2019/2944
- Conditions
- Breast Disease, Phyllodes Breast Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 15 Sep 2021 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 1 Oct 2020 (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.
To determine the feasibility of cryotherapy for B3 fibroepithelial lesions
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- lesion seen on ultrasound
- core biopsy revealed FEL of B3
- lesion </+3.5cm
- keen for cryotherapy instead of surgery
- has other breast lesions for followup
Key exclusion criteria (3 listed)
- cancer patients
- patients with bleeding diathesis
- lesions causing visible breast deformity
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 |
|---|---|---|
| cryotherapycomparison between cryotherapy and surgery | Procedure or surgery | – |
Primary outcome
recurrence of the lesion
Time frame: 2 years from procedure
assessed on ultrasound
breast cosmetic outcome
Time frame: at 1 year post procedure
patient self assessment of excellent (1), good (2), fair (3) poor (4). score of 1-4,1 being the best score
pain score
Time frame: immediate post procedure
using pain score scale of 0-10, a higher score indicates a worse outcome
pain score
Time frame: at 2 weeks post procedure
using pain score scale of 0-10, a higher score indicates a worse outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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.
Geok hoon lim principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy in people with Breast Disease and Phyllodes Breast Tumor, 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 5 inclusion and 3 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 5 Sep 2021. 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?
Contact Geok Hoon Lim (96392353, lim.gh@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of the lesion (time frame: 2 years from procedure). The study lists 4 primary outcomes in all. 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 5 Sep 2021.