Clinical trial · Interventional
Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella
Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment rate
Summary
Brief summary (as posted)
This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision. It is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision. follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\\or from a distance relapse. During these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fatty tissue transfer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- surgery by fatty tissue transfer
- interventionNames
- Procedure: fatty tissue transfer
- type
- NO_INTERVENTION
- label
- simple supervision
Primary outcomes (1)
- measure
- Verify that the disturbances of the radiological follow-up in 1 year will not be more frequent for the patient benefiting from fatty transfer with regard to a simple surveillance.
- timeFrame
- 1 year
Secondary outcomes (2)
- measure
- Estimate the technique on the cosmetic plan : On the quality and on the stability of the result. On the satisfaction of the patient.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * History of breast cancer treated by conservative surgery . * Normal inclusion radiological assessment normal (ACR1 or ACR2) * Moderate Deformations (Type I and II of the classification of Clough). * Delay with regard to the end of the radiotherapy superior or equal to one-year-old. * Moderated radio-dystrophies (\< Grade 2 of the score LENT/SOMA). * Signature of the informed consent * Patient benefiting from social security * Patient of more than 18 years old Exclusion Criteria: * Abnormal radiological assessment (ACR3, ACR4 or ACR5) * Absence of fatty excess . * radio surgical relapses with vast fibroses of the breast (\> Grade 2 of the score LENT/SOMA). * Patient under 18 years old. * administrative difficulties: impossibility to provide enlightened information to the patient, the refusal to sign the consent . * pregnant women or breast feeding women * patient under legal guardianship * bilateral breast cancer regardless histologic type.
References
Publications (0)
Data not yet available