Breast CancerNCT02464982
Psycho-esthetic Impact of Tattoo Technology as Part of Mammary Reconstruction After Surgery Against Breast Cancer
An observational study of Breast Cancer and Right or Left Breast Mammary Reconstruction, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Mammary reconstruction replaces total skin transplant, which may causing patient discomfort. It is a simple, painless and reproductible technology that avoids consequences and complications related to transplant. Tattoo helps patients to return faster to the normal life and close more easily the cancer episode. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Right or Left Breast Mammary Reconstruction, Malignant Neoplasm Reconstruction by Tattoo of Areola of Female Breast
- What is being tested?
- Tattoo
- Type of treatment
- Surgery or procedure
- How many people
- 107 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to May 2015
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women with 1 year non-invasive technology areola tattoo realized as part of 1 breast mammary reconstruction following an operated breast cancer.
Who may be able to join
- technology areola tattoo realized as part of 1 breast mammary reconstruction following an operated breast cancer
Who cannot join
- Two breasts operated patient
- surgical reconstruction
Trial locations and contacts
1 site in 1 country.
France1 site
esthetic, reconstruction and maxillo-facial surgery department, University Hospital
Strasbourg, 67000
About this study
Official title: Areola Tattoo: the End of a Long Therapeutic Process. A Patient's Quality of Life Dedicated Technology
Mammary reconstruction replaces total skin transplant, which may causing patient discomfort. It is a simple, painless and reproductible technology that avoids consequences and complications related to transplant. Tattoo helps patients to return faster to the normal life and close more easily the cancer episode.
The study purpose is to measure the patient's esthetic satisfaction degree on 1year areola tattoo realized following standard care.
Read the detailed description
Tattoo is realized as standard car as part of mammary reconstruction after surgery of patient suffering from breast cancer. We try to measured :
- Tattooed patient's satisfaction degree with qualitative questionnaire using four level satisfaction scale (very satisfied, satisfied, dissatisfied, very dissatisfied)
- Evaluate from patient and jury, the tall, form, color and areola position defects
- Evaluate professional jury's satisfaction degree regarding this areola tattoo technology, with the same patient criteria
- Conditions
- Breast Cancer, Right or Left Breast Mammary Reconstruction, Malignant Neoplasm Reconstruction by Tattoo of Areola of Female Breast
- Being tested
- Tattoo
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TattooProcedure or surgery
tattoo device with EC standards, and sterile single-use only needle
| Study group | Role | What they receive |
|---|---|---|
| Women with 1 year non-invasive technology areola tattoo | Women with 1 year non-invasive technology areola tattoo realized in standard care as part of 1 breast mammary reconstruction following an operated breast cancer Receives: Procedure: Tattoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's satisfaction degree with qualitative questionnaire about them areola tattoo realized after surgery as part of breast cancer treatment
Measured: 1 year after areola tattoo have been realized following standard care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startFeb 2012
- Primary completionMay 2015
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 University Hospital, Strasbourg, FranceThe 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie DUGUET, Principal investigator, esthetic, reconstruction and maxillo-facial surgery department, University Hospital, Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464982
- Sponsor's protocol ID
- PHRIP 2011 / 1 AMC
- Status last verified
- Apr 2016
- First submitted
- 3 Jun 2015
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Areola Tattoo: the End of a Long Therapeutic Process. A Patient's Quality of Life Dedicated Technology
- ClinicalTrials.gov ID
- NCT02464982
- Acronym / sponsor ID
- PHRIP 2011 / 1 AMC
- Conditions
- Breast Cancer, Right or Left Breast Mammary Reconstruction, Malignant Neoplasm Reconstruction by Tattoo of Areola of Female Breast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2015 (actual)
- First posted
- 8 Jun 2015 (estimated)
- 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.
Mammary reconstruction replaces total skin transplant, which may causing patient discomfort. It is a simple, painless and reproductible technology that avoids consequences and complications related to transplant. Tattoo helps patients to return faster to the normal life and close more easily the cancer episode.
The study purpose is to measure the patient's esthetic satisfaction degree on 1year areola tattoo realized following standard care.
Detailed description
Tattoo is realized as standard car as part of mammary reconstruction after surgery of patient suffering from breast cancer. We try to measured :
- Tattooed patient's satisfaction degree with qualitative questionnaire using four level satisfaction scale (very satisfied, satisfied, dissatisfied, very dissatisfied)
- Evaluate from patient and jury, the tall, form, color and areola position defects
- Evaluate professional jury's satisfaction degree regarding this areola tattoo technology, with the same patient criteria
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with 1 year non-invasive technology areola tattoo | – | Procedure: TattooWomen with 1 year non-invasive technology areola tattoo realized in standard care as part of 1 breast mammary reconstruction following an operated breast cancer |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with 1 year non-invasive technology areola tattoo realized as part of 1 breast mammary reconstruction following an operated breast cancer.
Key inclusion criteria (1 listed)
- technology areola tattoo realized as part of 1 breast mammary reconstruction following an operated breast cancer
Key exclusion criteria (2 listed)
- Two breasts operated patient
- surgical reconstruction
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 |
|---|---|---|
| Tattootattoo device with EC standards, and sterile single-use only needle | Procedure or surgery | Women with 1 year non-invasive technology areola tattoo |
Primary outcome
Patient's satisfaction degree with qualitative questionnaire about them areola tattoo realized after surgery as part of breast cancer treatment
Time frame: 1 year after areola tattoo have been realized following standard care
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 13 Apr 2016.
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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.
Sylvie DUGUET principal investigator
esthetic, reconstruction and maxillo-facial surgery department, University Hospital, Strasbourg
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 Right or Left Breast Mammary Reconstruction, run by University Hospital, Strasbourg, France at 1 site in France.
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 1 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 13 Apr 2016. 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 France. 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?
Patient's satisfaction degree with qualitative questionnaire about them areola tattoo realized after surgery as part of breast cancer treatment (time frame: 1 year after areola tattoo have been realized following standard care). 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 13 Apr 2016.