Breast CancerNCT05917834
Comparison of Nipple-areolar Complex Sensation According to Incision Types in Nipple-sparing Mastectomy
An observational study of Breast Cancer and Nipple Sparing Mastectomy, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
This study aims to assess nipple areolar complex sensation after nipple sparing mastectomy and compare the results according to different incisional approaches; specifically, inframammary fold (IMF) versus peri-areolar/radial. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Nipple Sparing Mastectomy
- What is being tested?
- Nipple sparing mastecomy with different incision placements
- How many people
- 105 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Oct 2019to 29 Nov 2021
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer undergoing nipple sparing mastectomy
Who may be able to join
- Females who are older than 18
- Patients who underwent nipple sparing mastectomy in Gangnam Severance Hospital
Who cannot join
- Loss or excision of NAC due to post-surgical necrosis
- Diagnosis of other conditions that may interfere with cutaneous sensation
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess nipple areolar complex sensation after nipple sparing mastectomy and compare the results according to different incisional approaches; specifically, inframammary fold (IMF) versus peri-areolar/radial. One-hundred-and-five post NSM patients from Oct 2019 to Nov 2021 have been recruited prospectively and evaluated for NAC sensory. A total of 97 patients (IMF 65 and peri-areolar/radial 32) were included in the analyses for comparison during follow up from 24 to 48 months after surgery. It was hypothesized that patients with IMF would have better outcomes for NAC senroy.
- Conditions
- Breast Cancer, Nipple Sparing Mastectomy
- Being tested
- Nipple sparing mastecomy with different incision placements
- Keywords
- NAC sensory, Mastectomy, NSM
- 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 mastecomy with different incision placementsBiological
Nipple sparing mastectomy was performed using Radial/Peri-areolar incision or imframammary incision
| Study group | Role | What they receive |
|---|---|---|
| Imframammary | Imframammary- NSM using imframammary incision Receives: Biological: Nipple sparing mastecomy with different incision placements | |
| Radial/Peri-areolar | Radial/Peri-areolar- NSM using Radial/Peri-areolar incision Receives: Biological: Nipple sparing mastecomy with different incision placements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of NAC sensory by pinprick test
Difference in NAC sensory loss between the patients with two different incisions.
Measured: 2-4 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start21 Oct 2019
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Jeong, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917834
- Sponsor's protocol ID
- 3-2019-0235
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nipple-areolar Complex Sensation According to Incision Types in Nipple-sparing Mastectomy
- ClinicalTrials.gov ID
- NCT05917834
- Acronym / sponsor ID
- 3-2019-0235
- Conditions
- Breast Cancer, Nipple Sparing Mastectomy
- Keywords
- NAC sensory, Mastectomy, NSM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 26 Jun 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.
This study aims to assess nipple areolar complex sensation after nipple sparing mastectomy and compare the results according to different incisional approaches; specifically, inframammary fold (IMF) versus peri-areolar/radial. One-hundred-and-five post NSM patients from Oct 2019 to Nov 2021 have been recruited prospectively and evaluated for NAC sensory. A total of 97 patients (IMF 65 and peri-areolar/radial 32) were included in the analyses for comparison during follow up from 24 to 48 months after surgery. It was hypothesized that patients with IMF would have better outcomes for NAC senroy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imframammary | – | Biological: Nipple sparing mastecomy with different incision placementsImframammary- NSM using imframammary incision |
| Radial/Peri-areolar | – | Biological: Nipple sparing mastecomy with different incision placementsRadial/Peri-areolar- NSM using Radial/Peri-areolar incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer undergoing nipple sparing mastectomy
Key inclusion criteria (2 listed)
- Females who are older than 18
- Patients who underwent nipple sparing mastectomy in Gangnam Severance Hospital
Key exclusion criteria (2 listed)
- Loss or excision of NAC due to post-surgical necrosis
- Diagnosis of other conditions that may interfere with cutaneous sensation
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 mastecomy with different incision placementsNipple sparing mastectomy was performed using Radial/Peri-areolar incision or imframammary incision | Biological | Imframammary, Radial/Peri-areolar |
Primary outcome
Loss of NAC sensory by pinprick test
Time frame: 2-4 years after surgery
Difference in NAC sensory loss between the patients with two different incisions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
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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.
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 Breast Cancer and Nipple Sparing Mastectomy, run by Gangnam Severance Hospital at 1 site in South Korea.
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 2 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: finished, as of the sponsor's last update on 26 Jun 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Loss of NAC sensory by pinprick test (time frame: 2-4 years after 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 26 Jun 2023.