Breast CancerEXCLUFATNCT04625621
Breast Reconstruction by Exclusive Lipomodulin : Feasibility, Evaluation of the Aesthetic Result and Quality of Life
An observational study of Breast Cancer and Mastectomy; Lymphedema, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
Breast cancer is the leading female cancer in metropolitan France in terms of incidence and death. Among the therapeutic arsenal for the treatment of these cancers, surgery plays a very important role and even if a conservative treatment is possible in the majority of cases, there is still an indication for mastectomy… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Mastectomy; Lymphedema
- How many people
- 118 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2020to 5 Feb 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: Patient treated by mastectomy for breast cancer having completed an exclusive lipomodeling reconstruction course (immediate or delayed reconstruction) at the ICO - Saint Herblain site between January 2012 and July 2020.
Who may be able to join
- Patients over 18 years of age
- Patient who benefited from immediate or delayed breast reconstruction by exclusive lipomodulin completed between 01/01/2012 and 07/31/2020.
- Agreeing to answer the questionnaire
Who cannot join
- Association with another prosthetic or autologous reconstruction technique planned at the beginning of the reconstruction procedure.
- Deceased patient
- Patient under guardianship or curators
- Patient opposed to the use of her data for research
Trial locations and contacts
1 site in 1 country.
About this study
Breast cancer is the leading female cancer in metropolitan France in terms of incidence and death. Among the therapeutic arsenal for the treatment of these cancers, surgery plays a very important role and even if a conservative treatment is possible in the majority of cases, there is still an indication for mastectomy in about 30% of cases.
Currently, only 30% of women who have undergone a mastectomy choose reconstruction.
Read more
The primary objective of breast reconstruction from a surgical point of view is to leave as few aesthetic and functional after-effects as possible while meeting the personal wishes of each woman according to her morphological, tissue and vascular characteristics.
There are currently 2 major surgical procedures for breast reconstruction: breast implant reconstructions and autologous reconstructions.
Breast reconstruction by prosthesis is the simplest and most widely used technique but, the controversies concerning implants with the PIP breast prostheses scandal in 2010 and more recently the anaplastic lymphoma scandal have tarnished the image of this type of reconstruction.
Alternatives to breast implants have been developed: autologous reconstructions using first pedicled tissue flaps, then free flaps, techniques that allow a more natural, more satisfactory aesthetic result with an evolution that follows the patient's own morphology but requiring specific training in microsurgery and not without postoperative complications.
Since 1999, the investigators have witnessed the evolution of another autologous technique, that of lipomodulin. Initially used to improve the results of reconstructions and the aesthetic sequelae of conservative treatments, it is now used as an exclusive reconstruction technique. Easily reproducible and offering several advantages, reconstruction by exclusive lipomodulin is increasingly appreciated by patients.
However, this increasingly practiced technique presents specific problems and this is what the investigators want to evaluate in this study.
The main objective of this study is to evaluate the practices within our establishment regarding breast reconstruction by exclusive lipomodulin in terms of feasibility. The secondary objectives are the evaluation of the cosmetic result and the quality of life of these patients after this type of reconstruction.
Read the detailed description
This is an observational, monocentric study using retrospective health data (2012-2020) combined with quality of life questionnaires.
The list of patients meeting the inclusion criteria will be collected using the Medical Information Department. Based on a screening of aggregate data from the center, the sample size is approximately 150 patients.
The questionnaires will be mailed to patients during a follow-up site visit:
- The WHOQOL-BRIEF
- The EXCLUFAT questionnaire
- The questionnaire to be completed by a third party. A phone call will be made to explain the principle of the study and answer any questions they may have.
The returned questionnaires will be analyzed. Other necessary data will be collected in the patients' computer files.
There is no provision for patient follow-up.
- Conditions
- Breast Cancer, Mastectomy; Lymphedema
- Medical subject headings
- Breast Neoplasms, Lymphedema
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the feasibility of the exclusive lipomodulin technique in breast reconstruction: Failure rate of the technique
Failure rate of the technique
Measured: 18 months
Secondary outcomes (3)
Evaluate the aesthetic result
Scale of evaluation of the aesthetic result by a third party (specific scale with 4 question/scale form 1 to 10).
Measured: 18 months
Evaluate patient satisfaction: BREAST-Q
BREAST-Q (Reported Outcome Assessment following Reconstructive Breast Surgery in 31 questions including 10 scale from 1 to 10)
Measured: 6 months
Assessing patient quality of life: WHOQOL BREF
World Health Organization Quality of Life - BREF (WHOQOL-BREF) is a self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment. In addition, there are 2 items that measure overall QOL and general health.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start26 Nov 2020
- Primary completion5 Jan 2021
- Study completion5 Feb 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
- Retrospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BRILLAUD-MEFLAH Victoire, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625621
- Sponsor's protocol ID
- ICO-2020-22
- Acronym
- EXCLUFAT
- Status last verified
- Mar 2021
- First submitted
- 7 Oct 2020
- Last updated
- 13 Feb 2026
- 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Reconstruction by Exclusive Lipomodulin : Feasibility, Evaluation of the Aesthetic Result and Quality of Life
- ClinicalTrials.gov ID
- NCT04625621
- Acronym / sponsor ID
- EXCLUFAT / ICO-2020-22
- Conditions
- Breast Cancer, Mastectomy; Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 12 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.
Breast cancer is the leading female cancer in metropolitan France in terms of incidence and death. Among the therapeutic arsenal for the treatment of these cancers, surgery plays a very important role and even if a conservative treatment is possible in the majority of cases, there is still an indication for mastectomy in about 30% of cases.
Currently, only 30% of women who have undergone a mastectomy choose reconstruction.
The primary objective of breast reconstruction from a surgical point of view is to leave as few aesthetic and functional after-effects as possible while meeting the personal wishes of each woman according to her morphological, tissue and vascular characteristics.
There are currently 2 major surgical procedures for breast reconstruction: breast implant reconstructions and autologous reconstructions.
Breast reconstruction by prosthesis is the simplest and most widely used technique but, the controversies concerning implants with the PIP breast prostheses scandal in 2010 and more recently the anaplastic lymphoma scandal have tarnished the image of this type of reconstruction.
Alternatives to breast implants have been developed: autologous reconstructions using first pedicled tissue flaps, then free flaps, techniques that allow a more natural, more satisfactory aesthetic result with an evolution that follows the patient's own morphology but requiring specific training in microsurgery and not without postoperative complications.
Since 1999, the investigators have witnessed the evolution of another autologous technique, that of lipomodulin. Initially used to improve the results of reconstructions and the aesthetic sequelae of conservative treatments, it is now used as an exclusive reconstruction technique. Easily reproducible and offering several advantages, reconstruction by exclusive lipomodulin is increasingly appreciated by patients.
However, this increasingly practiced technique presents specific problems and this is what the investigators want to evaluate in this study.
The main objective of this study is to evaluate the practices within our establishment regarding breast reconstruction by exclusive lipomodulin in terms of feasibility. The secondary objectives are the evaluation of the cosmetic result and the quality of life of these patients after this type of reconstruction.
Detailed description
This is an observational, monocentric study using retrospective health data (2012-2020) combined with quality of life questionnaires.
The list of patients meeting the inclusion criteria will be collected using the Medical Information Department. Based on a screening of aggregate data from the center, the sample size is approximately 150 patients.
The questionnaires will be mailed to patients during a follow-up site visit:
- The WHOQOL-BRIEF
- The EXCLUFAT questionnaire
- The questionnaire to be completed by a third party. A phone call will be made to explain the principle of the study and answer any questions they may have.
The returned questionnaires will be analyzed. Other necessary data will be collected in the patients' computer files.
There is no provision for patient follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient treated by mastectomy for breast cancer having completed an exclusive lipomodeling reconstruction course (immediate or delayed reconstruction) at the ICO - Saint Herblain site between January 2012 and July 2020.
Key inclusion criteria (3 listed)
- Patients over 18 years of age
- Patient who benefited from immediate or delayed breast reconstruction by exclusive lipomodulin completed between 01/01/2012 and 07/31/2020.
- Agreeing to answer the questionnaire
Key exclusion criteria (4 listed)
- Association with another prosthetic or autologous reconstruction technique planned at the beginning of the reconstruction procedure.
- Deceased patient
- Patient under guardianship or curators
- Patient opposed to the use of her data for research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the feasibility of the exclusive lipomodulin technique in breast reconstruction: Failure rate of the technique
Time frame: 18 months
Failure rate of the technique
3 secondary outcomes
Evaluate the aesthetic result
Time frame: 18 months
Evaluate patient satisfaction: BREAST-Q
Time frame: 6 months
Assessing patient quality of life: WHOQOL BREF
Time frame: 6 months
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 Feb 2026.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
BRILLAUD-MEFLAH Victoire, MD principal investigator
Institut de Cancérologie de l'Ouest
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 Mastectomy; Lymphedema, run by Institut Cancerologie de l'Ouest 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 3 inclusion and 4 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 Feb 2026. 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?
Evaluate the feasibility of the exclusive lipomodulin technique in breast reconstruction: Failure rate of the technique (time frame: 18 months). 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 Feb 2026.