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Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella

NCT01035268 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2018-08-22

No results posted yet for this study

Summary

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

Interventions

PROCEDURE

fatty tissue transfer

It will be proceeded to aspiration of the fat at the level of the natural steatomeries (hip, stomach), then in a transfer of the fat prepared in the breast by following the standardized protocol.

Sponsors & Collaborators

  • Institut Claudius Regaud

    lead OTHER

Principal Investigators

  • Ignacio GARRIDO, MD · Institut Claudius Regaud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-08
Primary Completion
2015-10-31
Completion
2017-02-21

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01035268 on ClinicalTrials.gov