Breast Cancer Early Stage Breast Cancer (Stage 1-3)NCT06676761
Outcomes of a Novel Technique Minimal Scar Mastectomy
An observational study of Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by KK Women's and Children's Hospital at 2 sites in Singapore.
Trial summary
Nipple sparing mastectomy is oncologically safe and has a good cosmetic outcome. However, nipple sparing mastectomy was conventionally performed with reconstruction. Minimal scar mastectomy (MSM) is a novel technique which could allow women, with non-ptotic breasts, who do not want reconstruction, to conserve their… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- nipple sparing mastectomy without reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Mar 2017to 31 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: breast cancer patients with non-ptotic breasts, who do not want reconstruction, to conserve their nipple areolar complex (NAC) and avoid the transverse scar associated with modified radical mastectomy.
Inclusion Criteria: breast cancer patients who opted for minimal scar mastectomy -
Exclusion Criteria: breast cancer patients who underwent conventional mastectomy
-
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore2 sites, 2 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore, 238255
Geok hoon Lim, 96392353, ghlimsg@yahoo.com.sg
- Recruiting
KK Women's and Children's Hospital
Singapore
Geok hoon Lim, 96392353, ghlimsg@yahoo.com.sg
About this study
Nipple sparing mastectomy is oncologically safe and has a good cosmetic outcome. However, nipple sparing mastectomy was conventionally performed with reconstruction. Minimal scar mastectomy (MSM) is a novel technique which could allow women, with non-ptotic breasts, who do not want reconstruction, to conserve their nipple areolar complex (NAC) and avoid the transverse scar associated with modified radical mastectomy. This is the first study on the oncologic and surgical outcomes of MSM.
- Being tested
- nipple sparing mastectomy without reconstruction
- Keywords
- breast cancer, nipple sparing mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nipple sparing mastectomy without reconstructionProcedure or surgery
nipple sparing mastectomy was conventionally performed with reconstruction. we aim to study the outcomes in the group of patients with Minimal scar mastectomy (MSM) who have nipple sparing mastectomy without reconstruction
| Study group | Role | What they receive |
|---|---|---|
| nipple sparing mastectomy without reconstruction | nipple sparing mastectomy without reconstruction Receives: Procedure: nipple sparing mastectomy without reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
oncological outcome
recurrence rate
Measured: 5 years from operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Mar 2017
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies 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
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
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
- NCT06676761
- Sponsor's protocol ID
- IRB 2020/2147
- Status last verified
- Oct 2024
- First submitted
- 5 Nov 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will consider sharing IPD when paper was accepted for publication
Publications
Lim GH, Allen JC, Ng RP. Oncoplastic round block technique has comparable operative parameters as standard wide local excision: a matched case-control study. Gland Surg. 2017 Aug;6(4):343-349. doi: 10.21037/gs.2017.03.06.
PubMed 28861374Lim GH. How to do minimal scar mastectomy: first-reported novel concept of nipple sparing mastectomy without reconstruction. ANZ J Surg. 2018 Dec;88(12):1345-1346. doi: 10.1111/ans.14941. Epub 2018 Nov 1. No abstract available.
PubMed 30384398
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of a Novel Technique Minimal Scar Mastectomy
- ClinicalTrials.gov ID
- NCT06676761
- Acronym / sponsor ID
- IRB 2020/2147
- Keywords
- breast cancer, nipple sparing mastectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 6 Nov 2024 (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.
Nipple sparing mastectomy is oncologically safe and has a good cosmetic outcome. However, nipple sparing mastectomy was conventionally performed with reconstruction. Minimal scar mastectomy (MSM) is a novel technique which could allow women, with non-ptotic breasts, who do not want reconstruction, to conserve their nipple areolar complex (NAC) and avoid the transverse scar associated with modified radical mastectomy. This is the first study on the oncologic and surgical outcomes of MSM.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nipple sparing mastectomy without reconstruction | – | Procedure: nipple sparing mastectomy without reconstructionnipple sparing mastectomy without reconstruction |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- breast cancer patients with non-ptotic breasts, who do not want reconstruction, to conserve their nipple areolar complex (NAC) and avoid the transverse scar associated with modified radical mastectomy.
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 |
|---|---|---|
| nipple sparing mastectomy without reconstructionnipple sparing mastectomy was conventionally performed with reconstruction. we aim to study the outcomes in the group of patients with Minimal scar mastectomy (MSM) who have nipple sparing mastectomy without reconstruction | Procedure or surgery | nipple sparing mastectomy without reconstruction |
Primary outcome
oncological outcome
Time frame: 5 years from operation
recurrence rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Background: PubMed 28861374Lim GH, Allen JC, Ng RP. Oncoplastic round block technique has comparable operative parameters as standard wide local excision: a matched case-control study. Gland Surg. 2017 Aug;6(4):343-349. doi: 10.21037/gs.2017.03.06.
- Background: PubMed 30384398Lim GH. How to do minimal scar mastectomy: first-reported novel concept of nipple sparing mastectomy without reconstruction. ANZ J Surg. 2018 Dec;88(12):1345-1346. doi: 10.1111/ans.14941. Epub 2018 Nov 1. No abstract available.
- Individual participant dataSharing planned: Undecided. will consider sharing IPD when paper was accepted for publication
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by KK Women's and Children's Hospital at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geok hoon Lim (96392353, ghlimsg@yahoo.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oncological outcome (time frame: 5 years from operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06676761, which also lists 2 linked publications.
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 6 Nov 2024.