Breast CancerNCT04640454
Assessment of Nipple Sparing Mastectomy as a Treatment Option for Breast Cancer
An observational study of Breast Cancer, run by Alexandria University at 1 site in Egypt.
Trial summary
Nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR) is a form of mastectomy that achieves optimal disease control and facilitates reconstruction. The study aimed to assess the oncological safety and aesthetic outcomes of nipple-sparing mastectomy and immediate breast reconstruction. Read more about this study
- Who is it for?
- Ages 28 to 68 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- nipple sparing mastectomy
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 1 Jan 2019
- How long will I take part?
- 2 Years
- 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 28 to 68 years
- Women only
- Adult, Older adult
Study population: The mean age of the studied patients was 44.00±9.47 years old; the youngest patient was 28 years old and the oldest one was 68 years old, the majority of patients were 40-50 years of age (54%) As regard the patients' marital status; 31 patients were married constituting 88.57 % and only 4 (11.4 %) patients were single The main complaint of 25 of them (71.42%) was painless breast lump while 8 cases (22.85%) presented with local recurrence after previous breast conservative surgery and only two case (5.7%) presented by extensive mammographic calcifications on screening mammography
Who may be able to join
- Diagnosis of ductal in situ carcinoma or infiltrating ductal carcinoma with a tumor diameter up to 3 cm
- Distance of the tumor from the nipple ≥ 2 cm
- Cancer or microcalcifications not localized in the central field.
- No blood secretions or other (nipple-areola complex) NAC disturbances
- Absence of skin involvement
- Indication to mastectomy for multifocal or diffuse microcalcifications
- Negative intraoperative assessment of NAC-bottom
Who cannot join
- Tumor or microcalcifications localized in the central quadrant or in the retroareolar region
- Blood secretions or other NAC alterations
- Positive intraoperative assessment of NAC-bottom
- Inflammatory carcinoma
- Paget's disease of the nipple
Trial locations and contacts
1 site in 1 country.
About this study
Nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR) is a form of mastectomy that achieves optimal disease control and facilitates reconstruction. The study aimed to assess the oncological safety and aesthetic outcomes of nipple-sparing mastectomy and immediate breast reconstruction.
35 female patients with breast cancer were included in the study. The investigators categorized the incisions into radial, inframammary, and periareolar incisions with planned reconstruction types; direct to implant (DTI), transversus rectus abdominis myocutaneous (TRAM) flap, latissimus dorsi myocutaneous (LD) flap, or LD with implant.
- Conditions
- Breast Cancer
- Being tested
- nipple sparing mastectomy
- Keywords
- breast cancer, mastectomy, breast reconstruction
- 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 mastectomyProcedure or surgery
The investigators categorized the incisions into radial, inframammary, and periareolar incisions with planned reconstruction types; direct to implant (DTI), transversus rectus abdominis myocutaneous (TRAM) flap, latissimus dorsi myocutaneous (LD) flap, or LD with implant.
What is being measured
The primary outcome is the main question the study is designed to answer.
patients complications after nipple sparing mastectomy
Complete general examination, local examination of the skin, nipple and areola were done to determine whether the patients suffered from any complaints
Measured: 2017-2019
Secondary outcomes (1)
Aesthetic results assessed by Tzafetta et al scoring system
Measured: 2017-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Jan 2017
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
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.
- More trials run by Alexandria UniversityThe 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
- Prospective
- Enrolment
- 35 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640454
- Sponsor's protocol ID
- 13-27-10
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nipple Sparing Mastectomy as a Treatment Option for Breast Cancer
- ClinicalTrials.gov ID
- NCT04640454
- Acronym / sponsor ID
- 13-27-10
- Conditions
- Breast Cancer
- Keywords
- breast cancer, mastectomy, breast reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 23 Nov 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.
Nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR) is a form of mastectomy that achieves optimal disease control and facilitates reconstruction. The study aimed to assess the oncological safety and aesthetic outcomes of nipple-sparing mastectomy and immediate breast reconstruction.
35 female patients with breast cancer were included in the study. The investigators categorized the incisions into radial, inframammary, and periareolar incisions with planned reconstruction types; direct to implant (DTI), transversus rectus abdominis myocutaneous (TRAM) flap, latissimus dorsi myocutaneous (LD) flap, or LD with implant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 28 to 68 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The mean age of the studied patients was 44.00±9.47 years old; the youngest patient was 28 years old and the oldest one was 68 years old, the majority of patients were 40-50 years of age (54%) As regard the patients' marital status; 31 patients were married constituting 88.57 % and only 4 (11.4 %) patients were single The main complaint of 25 of them (71.42%) was painless breast lump while 8 cases (22.85%) presented with local recurrence after previous breast conservative surgery and only two case (5.7%) presented by extensive mammographic calcifications on screening mammography
Key inclusion criteria (7 listed)
- Diagnosis of ductal in situ carcinoma or infiltrating ductal carcinoma with a tumor diameter up to 3 cm
- Distance of the tumor from the nipple ≥ 2 cm
- Cancer or microcalcifications not localized in the central field.
- No blood secretions or other (nipple-areola complex) NAC disturbances
- Absence of skin involvement
Key exclusion criteria (5 listed)
- Tumor or microcalcifications localized in the central quadrant or in the retroareolar region
- Blood secretions or other NAC alterations
- Positive intraoperative assessment of NAC-bottom
- Inflammatory carcinoma
- Paget's disease of the nipple
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 mastectomyThe investigators categorized the incisions into radial, inframammary, and periareolar incisions with planned reconstruction types; direct to implant (DTI), transversus rectus abdominis myocutaneous (TRAM) flap, latissimus dorsi myocutaneous (LD) flap, or LD with implant. | Procedure or surgery | – |
Primary outcome
patients complications after nipple sparing mastectomy
Time frame: 2017-2019
Complete general examination, local examination of the skin, nipple and areola were done to determine whether the patients suffered from any complaints
1 secondary outcome
Aesthetic results assessed by Tzafetta et al scoring system
Time frame: 2017-2019
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 23 Nov 2020.
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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, run by Alexandria University at 1 site in Egypt.
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 7 inclusion and 5 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 23 Nov 2020. 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 Egypt. 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?
patients complications after nipple sparing mastectomy (time frame: 2017-2019). 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 23 Nov 2020.