NCT04130373

Brief Summary

Autologous fat grafting, also known as lipofilling, is a surgical technique consisting in the processing and transfer of adipose tissue from one area in our organism (hips, thighs) to region which in need of reconstructive and aesthetic correction. The technique is frequently used after radical or conservative mammary surgery, aiming to achieve better aesthetic results, reduce pain induced by both surgery and radiotherapy. The scientific community was widely involved in the debate regarding the use of mesenchymal/stem cells in a patient with high risk of tumor progression due to their elevated proliferative profile. This study aims to retrospectively evaluate the oncological safety in the use of lipofilling in patients who underwent oncological and reconstructive treatment in our Institute.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,510

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

October 15, 2019

Last Update Submit

October 28, 2019

Conditions

Pain, Postoperative

Keywords

Autologous fat graftingLipofillingBreast cancerBreast reconstruction

Outcome Measures

Primary Outcomes (1)

  • Oncological safety of autologous fat grafting

    Percentage of disease relapse in loco

    Two years

Secondary Outcomes (3)

  • Establishment of timing in disease relapse

    Two years

  • Establish the distribution in disease relapses

    Two years

  • Establish overall survival rate in experimental and control groups

    Two years

Study Arms (2)

Women receiving autologous fat grafting

Women who received breast reconstruction and autologous fat grafting.

Procedure: Autologous fat grafting procedureProcedure: Breast reconstruction

Control

Women who received breast reconstruction only.

Procedure: Breast reconstruction

Interventions

Autologous fat grafting procedurePROCEDURE

Surgical intervention based on the injection of autologous fat grafting after radical or conservative breast surgery and breast reconstruction.

Women receiving autologous fat grafting
Breast reconstructionPROCEDURE

Breast reconstructive procedures after oncological radical or conservative breast surgery

ControlWomen receiving autologous fat grafting

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients with breast carcinoma (any histological type, carcinoma in situ included) and treated with radical or conservative surgery and lipofilling. Patients received a minimum of two year follow up.

You may qualify if:

  • female
  • breast carcinoma (any histological type, carcinoma in situ included) treated with radical or conservative surgery
  • group treated with lipofilling and group which didnt receive lipofilling
  • timing: retrospective evaluation of cases form 2006 to 2016, with a minimum of two year follow up

You may not qualify if:

  • neoplasie different from infiltrating and in sutu breast carcinoma
  • in situ lobular carcinoma
  • patients with breast carcinoma and metastasis
  • lipofilling procedure used before the oncological treatment for breast carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Conditions

Pain, PostoperativeBreast Neoplasms

Interventions

Mammaplasty

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsPlastic Surgery ProceduresSurgical Procedures, Operative

Study Officials

  • Marco Klinger, MD

    Istituto Clinico Humanitas

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 15, 2019

First Posted

October 17, 2019

Study Start

June 1, 2019

Primary Completion

January 1, 2020

Study Completion

June 1, 2020

Last Updated

October 30, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)