Breast CancerLIMBONCT06101732
LIMBO : Breast Reconstruction by Lipomodeling Alone or With Flap: Evaluation in Franche-Comté
An observational study of Breast Cancer and Surgery, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The Limbo study is a retrospective descriptive study which aims to establish the current state of breast reconstruction surgery at the Besançon University Hospital and Hôpital Nord Franche-Comté, between October 2017 and December 2021. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Surgery
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2022to 13 Oct 2022
- 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
- Adult, Older adult
Study population: Patient who has undergone breast reconstruction using lipomodelling alone or in association with a flap (greater dorsal, DIEP Deep Inferior Epigastric Perforator flap or TRAM Tranverse Rectus Abdominis Myocutaneous Flap)
Who may be able to join
- Patient who has undergone breast reconstruction using lipomodelling alone or in association with a flap (greater dorsal, DIEP Deep Inferior Epigastric Perforator flap or TRAM Tranverse Rectus Abdominis Myocutaneous Flap), since October 2017.
- Patient whose follow-up in plastic surgery is considered completed (final result obtained, patient lost to follow-up or not wishing to continue) at the time of data collection.
Who cannot join
- Patient under 18 at first consultation
- Opposition of the patient to the collection of her data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breast Reconstruction by Lipomodeling Alone or With Flap: Evaluation in Franche-Comté
The Limbo study is a retrospective descriptive study which aims to establish the current state of breast reconstruction surgery at the Besançon University Hospital and Hôpital Nord Franche-Comté, between October 2017 and December 2021.
- Conditions
- Breast Cancer, Surgery
- Keywords
- lipodelling, breast reconstruction
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
number of surgical procedures according to the type of breast reconstruction using lipomodelling alone or in combination with a flap
number of surgical procedures
Measured: Between october 2017 and 2022
Secondary outcomes (11)
description of patients' age
patient age
Measured: at inclusion
description of patients' Body Mass Index
Body Mass Index
Measured: at inclusion
description of patients' menopause status
menopause status
Measured: at the time of data collection
description of patients' smoking status
smoking status
Measured: at inclusion
description of patients' diabetes or other medical condition
Measured: at inclusion
description of patients' relevant medical history
relevant medical history
Measured: at inclusion
description of patients' History of breast surgery
hsitory of breast surgery
Measured: at inclusion
description of patients' type of cancer
cancer histology
Measured: at inclusion
description of patients' type of surgical treatment
type of breast reconstruction using lipomodelling alone or in combination with a flap
Measured: at inclusion
description of patients' Type of treatment associated with surgery
Type of treatment associated with surgery
Measured: at inclusion
description of Time elapsed between mastectomy and reconstruction
number of month between the date of mastectomy and date of reconstruction
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start5 May 2022
- Primary completion13 Oct 2022
- Study completion13 Oct 2022
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 Centre Hospitalier Universitaire de BesanconThe 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
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101732
- Sponsor's protocol ID
- 2022/684
- Acronym
- LIMBO
- Status last verified
- Jan 2023
- First submitted
- 17 Oct 2023
- Last updated
- 27 Oct 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 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Reconstruction by Lipomodeling Alone or With Flap: Evaluation in Franche-Comté
- ClinicalTrials.gov ID
- NCT06101732
- Acronym / sponsor ID
- LIMBO / 2022/684
- Conditions
- Breast Cancer, Surgery
- Keywords
- lipodelling, breast reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 13 Oct 2022 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 26 Oct 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.
The Limbo study is a retrospective descriptive study which aims to establish the current state of breast reconstruction surgery at the Besançon University Hospital and Hôpital Nord Franche-Comté, between October 2017 and December 2021.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patient who has undergone breast reconstruction using lipomodelling alone or in association with a flap (greater dorsal, DIEP Deep Inferior Epigastric Perforator flap or TRAM Tranverse Rectus Abdominis Myocutaneous Flap)
Key inclusion criteria (2 listed)
- Patient who has undergone breast reconstruction using lipomodelling alone or in association with a flap (greater dorsal, DIEP Deep Inferior Epigastric Perforator flap or TRAM Tranverse Rectus Abdominis Myocutaneous Flap), since October 2017.
- Patient whose follow-up in plastic surgery is considered completed (final result obtained, patient lost to follow-up or not wishing to continue) at the time of data collection.
Key exclusion criteria (2 listed)
- Patient under 18 at first consultation
- Opposition of the patient to the collection of her data
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
number of surgical procedures according to the type of breast reconstruction using lipomodelling alone or in combination with a flap
Time frame: Between october 2017 and 2022
number of surgical procedures
11 secondary outcomes
description of patients' age
Time frame: at inclusion
description of patients' Body Mass Index
Time frame: at inclusion
description of patients' menopause status
Time frame: at the time of data collection
description of patients' smoking status
Time frame: at inclusion
description of patients' diabetes or other medical condition
Time frame: at inclusion
description of patients' relevant medical history
Time frame: at inclusion
description of patients' History of breast surgery
Time frame: at inclusion
description of patients' type of cancer
Time frame: at inclusion
description of patients' type of surgical treatment
Time frame: at inclusion
description of patients' Type of treatment associated with surgery
Time frame: at inclusion
description of Time elapsed between mastectomy and reconstruction
Time frame: at inclusion
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 27 Oct 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 Surgery, run by Centre Hospitalier Universitaire de Besancon 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 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 27 Oct 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 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?
number of surgical procedures according to the type of breast reconstruction using lipomodelling alone or in combination with a flap (time frame: Between october 2017 and 2022). 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 27 Oct 2023.