Trial Title:
International Prospective REgistry on Pre-pectorAl Breast REconstruction
NCT ID:
NCT05817175
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Cancer
Breast reconstruction
Pre-pectoral Breast Prosthesis
Mastectomy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
pre-pectoral breast reconstruction
Description:
to prospectively evaluate the utilization of the pre-pectoral approach, and evaluate
oncological and aesthetic outcomes related to each type of surgical technique and the use
of postmastectomy radiation therapy
Summary:
This is an international multicenter prospective cohort study aimed at collecting data on
breast reconstruction techniques with pre-pectoral implants after mastectomy for breast
cancer. The aim of the study is to collect data on the surgical, aesthetic and
oncological results, as well as on the quality of life of the patients who will undergo
breast reconstruction with a pre-pectoral approach.
Detailed description:
1,236 patients undergoing mastectomy for breast cancer and subsequent pre-pectoral breast
reconstruction will be enrolled. Being an observational study, the diagnostic-therapeutic
path of the patients will not be modified in any way. Therefore, no risks are anticipated
for the patients who will participate in this study. Potential benefits deriving from the
study will be for future patients for whom good quality data will be available which can
guide the choice of the type of breast reconstruction to be performed, in particular the
most appropriate type of technique in the pre-pectoral approach.
Criteria for eligibility:
Study pop:
All patients who are candidates for implant-based reconstruction should be informed about
the possible participation to this clinical study. The inclusion and exclusion criteria
are verified by the investigator and an informed consent is obtained from the patient.
The therapeutic pattern should be followed according to institutional and national
standards. Since this is a non-interventional trial, the study sites do not deviate from
their own study protocol at any timepoint.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Female patients older than 18 years old
- Signed informed consent form
- Patients undergoing mono or bilateral therapeutic mastectomy
- Patients undergoing pre-pectoral implant-based breast reconstruction with implant or
expander with or without mesh
Exclusion Criteria:
- Male patients
- Patients not suitable for surgical treatment
- Patients undergoing subpectoral reconstruction
- Patients undergoing breast reconstruction with autologous tissue.
Gender:
Female
Gender based:
Yes
Gender description:
Female patients older than 18 years old
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Univesidad de Buenos Aires
Address:
City:
Buenos Aires
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Eduardo Gonzalez, MD
Facility:
Name:
Mansoura Insurance
Address:
City:
Mansoura
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Khaled Ali
Facility:
Name:
Mansoura Oncology
Address:
City:
Mansoura
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Khaled Ali, MD
Facility:
Name:
National ans Kapodistrian University of Athens
Address:
City:
Athens
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Michalis Kontos, MD
Facility:
Name:
Ospedale San Raffaele
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
ORESTE DAVIDE GENTILINI, MD
Email:
gentilini.oreste@hsr.it
Investigator:
Last name:
ROSA DI MICCO
Email:
Sub-Investigator
Investigator:
Last name:
LUIGI GIANOLLI
Email:
Sub-Investigator
Investigator:
Last name:
CARLA CANEVARI
Email:
Sub-Investigator
Investigator:
Last name:
PIETRO PANIZZA
Email:
Sub-Investigator
Investigator:
Last name:
CLAUDIO LOSIO
Email:
Sub-Investigator
Investigator:
Last name:
ELENA VENTURINI
Email:
Sub-Investigator
Investigator:
Last name:
ZUBER VERONICA
Email:
Sub-Investigator
Investigator:
Last name:
ANNARITA SAVI
Email:
Sub-Investigator
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli
Address:
City:
Roma
Zip:
00136
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Gianluca Franceschini, MD
Facility:
Name:
University Hospital of Karol Marcinkowski
Address:
City:
Zielona Góra
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Dawid Murawa
Facility:
Name:
Prof. Dr. Ion Chiricuta Institute of Oncology
Address:
City:
Cluj-Napoca
Country:
Romania
Status:
Recruiting
Contact:
Last name:
Maximilian Muntean, MD
Facility:
Name:
Hospital del Mar
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Maria Del Mar Bernet-Tomas, MD
Facility:
Name:
Marmara University School of medicine
Address:
City:
Istanbul
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Umit Ugurlu, MD
Facility:
Name:
University Hospitals of Leicester
Address:
City:
Leicester
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Tim Rattay
Start date:
October 16, 2023
Completion date:
September 10, 2027
Lead sponsor:
Agency:
IRCCS San Raffaele
Agency class:
Other
Collaborator:
Agency:
EUBREAST ETS
Agency class:
Other
Source:
IRCCS San Raffaele
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05817175
