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Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Ignacio GARRIDO, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

08 SEIN 08

NCT ID:

NCT01035268

Start Date:

January 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer treated by conservative surgery
  • Breast Neoplasms

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