Breast CancerQUARLAMINCT05316389
Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life
An observational study of Breast Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
The dorsalis major flap is an interesting therapeutic option in breast reconstruction because of reliability and reproducibility. In recent years, the minimal flap technique has been developed, which consists of removing only a portion of the of the large dorsal muscle to reduce the painful and functional sequelae of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2022to 19 May 2026
- 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 at the ICO Angers site with an indication for immediate or deferred breast reconstruction for their breast cancer
Who may be able to join
- Patients with a desire for breast reconstruction
- Indication for mastectomy or with a history of mastectomy, with or without preservation of the skin skin,
- Breast reconstruction procedure by LDPM performed between January 2017 and September2021, (retrospective cohort )
- Breast reconstruction procedure by LDPM or by prosthesis performed from February 2022 (prospective cohort)
- Information to the patient and collection of her non-opposition
- Affiliation to a social security system, or beneficiary of such a system
Who cannot join
- Performance of a breast reconstruction by a technique other than LDPM or prosthesis
- Patient opposed to the use of her data for research
- Person in an emergency situation, adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or unable to express his consent,
- Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological psychological reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimal Harvest Dorsalis Major Flap Breast Reconstruction: Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life
The dorsalis major flap is an interesting therapeutic option in breast reconstruction because of reliability and reproducibility.
In recent years, the minimal flap technique has been developed, which consists of removing only a portion of the of the large dorsal muscle to reduce the painful and functional sequelae of this surgery.
Read more
The objective of this prospective study is to evaluate the functional and aesthetic results in patients who have undergone who have undergone this procedure (prospective cohort) or who will undergo this procedure or prosthetic reconstruction (prospective cohort).
The investigators also wish to evaluate the quality of life of patients after reconstruction with a minimal harvest dorsalis flap or a prosthesis or prosthesis in the prospective cohort.
Read the detailed description
Retrospective Cohort :
- Clinical data reconstruction and follow-up up to 1 year
- DASH questionnaire
- Breast Q
- aesthetic evaluation (patient and surgeon and other health professional)
Prospective Cohort :
- Clinical data reconstruction and follow-up up to 1 year
- DASH questionnaire (pre-op, at 6 month and at 12 month)
- Breast Q(pre-op, at 6 month and at 12 month)
- aesthetic evaluation (patient and surgeon and other health professional) (at 6 month and at 12 month)
- Conditions
- Breast Cancer
- Being tested
- 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.
Breast reconstructionProcedure or surgery
Muscle sparing Latissimus Dorsi Flap or prothesis
| Study group | Role | What they receive |
|---|---|---|
| A Retrospective | A = retrospective cohort including all patients treated at the ICO Angers between January 2017 and September 2021 Receives: Procedure: Breast reconstruction | |
| B Prospective | B = prospective including all patients treated at the ICO from February 2022 (2 years of recruitment) Receives: Procedure: Breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional evaluation of the shoulder and upper limb (mobility and pain)
Disabilities of the Arm, Shoulder and Hand (DASH) (0 = no disability to 100 = maximum disability)
Measured: 6 month
Secondary outcomes (3)
satisfaction of aesthetic by the patient and by the surgeon
5 numerical scales (from 0 to 5) measuring overall satisfaction with the reconstruction, general appearance of the breast, breast shape, breast consistency and breast volume
Measured: 6 month
occurrence of postoperative complications
complications
Measured: 6 month
quality of life through the Breast-Q questionnaire
Breast-Q questionnaire
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 posted7 Apr 2022
- Study start21 Feb 2022
- Primary completion19 May 2026
- Study completion19 May 2026
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
- Cross-sectional
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia DE FREITAS, Principal investigator, ICO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316389
- Sponsor's protocol ID
- ICO-2021-05
- Acronym
- QUARLAMI
- Status last verified
- Feb 2026
- First submitted
- 11 Mar 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Harvest Dorsalis Major Flap Breast Reconstruction: Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life
- ClinicalTrials.gov ID
- NCT05316389
- Acronym / sponsor ID
- QUARLAMI / ICO-2021-05
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 7 Apr 2022 (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 dorsalis major flap is an interesting therapeutic option in breast reconstruction because of reliability and reproducibility.
In recent years, the minimal flap technique has been developed, which consists of removing only a portion of the of the large dorsal muscle to reduce the painful and functional sequelae of this surgery.
The objective of this prospective study is to evaluate the functional and aesthetic results in patients who have undergone who have undergone this procedure (prospective cohort) or who will undergo this procedure or prosthetic reconstruction (prospective cohort).
The investigators also wish to evaluate the quality of life of patients after reconstruction with a minimal harvest dorsalis flap or a prosthesis or prosthesis in the prospective cohort.
Detailed description
Retrospective Cohort :
- Clinical data reconstruction and follow-up up to 1 year
- DASH questionnaire
- Breast Q
- aesthetic evaluation (patient and surgeon and other health professional)
Prospective Cohort :
- Clinical data reconstruction and follow-up up to 1 year
- DASH questionnaire (pre-op, at 6 month and at 12 month)
- Breast Q(pre-op, at 6 month and at 12 month)
- aesthetic evaluation (patient and surgeon and other health professional) (at 6 month and at 12 month)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Retrospective | – | Procedure: Breast reconstructionA = retrospective cohort including all patients treated at the ICO Angers between January 2017 and September 2021 |
| B Prospective | – | Procedure: Breast reconstructionB = prospective including all patients treated at the ICO from February 2022 (2 years of recruitment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the ICO Angers site with an indication for immediate or deferred breast reconstruction for their breast cancer
Key inclusion criteria (6 listed)
- Patients with a desire for breast reconstruction
- Indication for mastectomy or with a history of mastectomy, with or without preservation of the skin skin,
- Breast reconstruction procedure by LDPM performed between January 2017 and September2021, (retrospective cohort )
- Breast reconstruction procedure by LDPM or by prosthesis performed from February 2022 (prospective cohort)
- Information to the patient and collection of her non-opposition
Key exclusion criteria (4 listed)
- Performance of a breast reconstruction by a technique other than LDPM or prosthesis
- Patient opposed to the use of her data for research
- Person in an emergency situation, adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or unable to express his consent,
- Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological psychological reasons.
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 |
|---|---|---|
| Breast reconstructionMuscle sparing Latissimus Dorsi Flap or prothesis | Procedure or surgery | A Retrospective, B Prospective |
Primary outcome
functional evaluation of the shoulder and upper limb (mobility and pain)
Time frame: 6 month
Disabilities of the Arm, Shoulder and Hand (DASH) (0 = no disability to 100 = maximum disability)
3 secondary outcomes
satisfaction of aesthetic by the patient and by the surgeon
Time frame: 6 month
occurrence of postoperative complications
Time frame: 6 month
quality of life through the Breast-Q questionnaire
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 12 Aug 2026.
- Individual participant dataSharing planned: No
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.
Julia DE FREITAS principal investigator
ICO
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 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 6 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 12 Aug 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?
functional evaluation of the shoulder and upper limb (mobility and pain) (time frame: 6 month). 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 12 Aug 2026.