Breast NeoplasmsNCT03105570
The Oncological Safety and Cosmetic Outcome of Areola Sparing Mastectomy : a Single Arm, Prospective, Cohort Study
A study testing Areola Sparing Mastectomy in people with Breast Neoplasms, run by Peking University People's Hospital at 1 site in China.
Trial summary
To balance the oncological safety and cosmetic outcome is the basic principle of modern breast surgery. To preserve the nipple-areolar complex shows attractive cosmetic advantage but concerns regarding local recurrence make the oncological safety of nipple sparing mastectomy a controversial issue. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Areola Sparing Mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 1 May 2024
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed invasive or in situ breast cancer.
- cTis-2N0-1M0.
- Indicated for total mastectomy and desire immediate breast reconstruction.
Who cannot join
- cT3-4 or cN2-N3 breast cancer.
- Retraction of nipple or areola.
- Involvement of subcutaneous layer by cancer on ultrasound or MRI.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 10044
Houpu Yang, MD, 010-88324010, yanghoupu@pkuph.edu.cn
Shu Wang, MD
About this study
To balance the oncological safety and cosmetic outcome is the basic principle of modern breast surgery. To preserve the nipple-areolar complex shows attractive cosmetic advantage but concerns regarding local recurrence make the oncological safety of nipple sparing mastectomy a controversial issue. Since the involvement of areolar pigmented skin by cancer is rare compared to that of nipple, we designed the current study to investigate the oncological safety and cosmetic outcome of Areola Sparing Mastectomy.
Read the detailed description
Primary breast cancer originated from areolae is rare. We hypothesized that nipple and areola are two separate anatomy tissue and have different oncological impact on the treatment of breast cancer. Areola Sparing Mastectomy (ASM) is a innovative procedure that involves of removal of nipple and preservation of areola the pigmented skin of which would improve the cosmetic outcome of mastectomy and lead to a illusion of congenital crater nipple in some patients.
- Conditions
- Breast Neoplasms
- Being tested
- Areola Sparing Mastectomy
- Keywords
- breast neoplasms, Mastectomy, Subcutaneous, Areola
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Areola Sparing MastectomyProcedure or surgery
Also called Nipple coring
A small circular incision would be made to separate nipple from breast and an additional incision directly extended from nipple or located at other part of breast such as infra-mammary fold and subaxillary area would be made to remove the total mammary parenchyma. Routine implant based or flap base reconstruction would be performed subsequentially. Nipple reconstruction is optional.
| Study group | Role | What they receive |
|---|---|---|
| Areola sparing mastectomy. | Experimental | Eligible patients undergo areola sparing mastectomy. Receives: Procedure: Areola Sparing Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of areolar area
The frequency of histologically confirmed recurrence on the preserved pigmented areolar area.
Measured: Five years after initial surgery
Secondary outcomes (3)
Cosmetic effect of reconstructed breast
The cosmetic results evaluated by a surgeon and a nurse through reviewing photographs.
Measured: 2-4 weeks after surgery; 2 years and 5 years after surgery.
Adverse effect of surgery
Wound dehiscence, infection, suture exposure and extrusion.
Measured: 4 weeks after surgery.
Disease free survival
Survival time to any recurrence and any cause death.
Measured: 5 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start1 May 2017
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking University People'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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Armed, prospective, open label study
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Houpu Yang, Peking University People's Hospital
- Investigators
- Shu Wang, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105570
- Sponsor's protocol ID
- ASM-China
- Status last verified
- Oct 2022
- First submitted
- 4 Apr 2017
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oncological Safety and Cosmetic Outcome of Areola Sparing Mastectomy : a Single Arm, Prospective, Cohort Study
- ClinicalTrials.gov ID
- NCT03105570
- Acronym / sponsor ID
- ASM-China
- Conditions
- Breast Neoplasms
- Keywords
- breast neoplasms, Mastectomy, Subcutaneous, Areola
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 10 Apr 2017 (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 balance the oncological safety and cosmetic outcome is the basic principle of modern breast surgery. To preserve the nipple-areolar complex shows attractive cosmetic advantage but concerns regarding local recurrence make the oncological safety of nipple sparing mastectomy a controversial issue. Since the involvement of areolar pigmented skin by cancer is rare compared to that of nipple, we designed the current study to investigate the oncological safety and cosmetic outcome of Areola Sparing Mastectomy.
Detailed description
Primary breast cancer originated from areolae is rare. We hypothesized that nipple and areola are two separate anatomy tissue and have different oncological impact on the treatment of breast cancer. Areola Sparing Mastectomy (ASM) is a innovative procedure that involves of removal of nipple and preservation of areola the pigmented skin of which would improve the cosmetic outcome of mastectomy and lead to a illusion of congenital crater nipple in some patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Armed, prospective, open label study
| Arm | Type | Receives |
|---|---|---|
| Areola sparing mastectomy. | Experimental | Procedure: Areola Sparing MastectomyEligible patients undergo areola sparing mastectomy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed invasive or in situ breast cancer.
- cTis-2N0-1M0.
- Indicated for total mastectomy and desire immediate breast reconstruction.
Key exclusion criteria (3 listed)
- cT3-4 or cN2-N3 breast cancer.
- Retraction of nipple or areola.
- Involvement of subcutaneous layer by cancer on ultrasound or MRI.
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 |
|---|---|---|
| Areola Sparing MastectomyAlso: Nipple coringA small circular incision would be made to separate nipple from breast and an additional incision directly extended from nipple or located at other part of breast such as infra-mammary fold and subaxillary area would be made to remove the total mammary parenchyma. Routine implant based or flap base reconstruction would be performed subsequentially. Nipple reconstruction is optional. | Procedure or surgery | Areola sparing mastectomy. |
Primary outcome
Recurrence of areolar area
Time frame: Five years after initial surgery
The frequency of histologically confirmed recurrence on the preserved pigmented areolar area.
3 secondary outcomes
Cosmetic effect of reconstructed breast
Time frame: 2-4 weeks after surgery; 2 years and 5 years after surgery.
Adverse effect of surgery
Time frame: 4 weeks after surgery.
Disease free survival
Time frame: 5 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Shu Wang, MD principal investigator
Peking University People'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 Areola Sparing Mastectomy in people with Breast Neoplasms, run by Peking University People's Hospital at 1 site in China.
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 3 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 17 Oct 2022. 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 China. 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 Houpu Yang, MD (88324010, yanghoupu@pkuph.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of areolar area (time frame: Five years after initial surgery). 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 17 Oct 2022.