Informations générales (source: ClinicalTrials.gov)
Prospective Evaluation of a Predictive Toxicity Test Post Radiotherapy After Mastectomy With Immediate Implant Reconstruction (PRETORIA)
Interventional
N/A
Institut du Cancer de Montpellier - Val d'Aurelle (Voir sur ClinicalTrials)
décembre 2020
juin 2027
06 novembre 2024
This study evaluates the capacity of the NovaGray RILA Breast® test to predict the
toxicity linked to radiotherapy and the impact of implant breast reconstruction.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 09/01/2025 11:32:11 | Contacter | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Tenon | Michael Atlan | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| centre Antoine Lacassagne - 06189 - Nice - France | Maud DUQUESNE | Contact (sur clinicalTrials) | |||
| Centre Georges François Leclerc - 21079 - Dijon - France | Laura VINCENT | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - 69373 - Lyon - France | Marie-Adele Dammacco | Contact (sur clinicalTrials) | |||
| Institut Claudius Regaud - 31059 - Toulouse - France | Carole MASSABEAU | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - 44805 - Saint-Herblain - France | Victoire Brillaud-Meflah | Contact (sur clinicalTrials) | |||
| Institut du Cancer de Montpellier - 34298 - Montpellier - France | Marian Gutowski | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmette - 13009 - Marseille - France | Marie Bannier | Contact (sur clinicalTrials) | |||
Critères
Homme
Inclusion Criteria:
- Age ≥18 years
- Patients with histologically confirmed breast cancer with indication of mastectomy
or surgery with mastectomy performed
- Indication of wall chest radiation after mastectomy
- Patient's agreement to receive or having had an immediate breast reconstruction by
implant in one or two steps, with or without a dermal or synthetic matrix (depending
on the habits of the center)
- Performance Status 0-1
- Consent signed before any study procedure
- Patient geographically accessible for follow-up
- Affiliated to the French national social security system
- Age ≥18 years
- Patients with histologically confirmed breast cancer with indication of mastectomy
or surgery with mastectomy performed
- Indication of wall chest radiation after mastectomy
- Patient's agreement to receive or having had an immediate breast reconstruction by
implant in one or two steps, with or without a dermal or synthetic matrix (depending
on the habits of the center)
- Performance Status 0-1
- Consent signed before any study procedure
- Patient geographically accessible for follow-up
- Affiliated to the French national social security system
- Breast reconstruction with flap
- Inflammatory breast cancer (cT4d)
- Skin or parietal breast cancer (cT4 a, b or c)
- Metastatic patients
- Patients with bilateral breast cancer
- History of homolateral breast cancer treated with radiotherapy
- History of contralateral breast cancer
- Pregnant or breastfeeding women
- Legal incapacity or physical, psychological or mental status interfering with the
patient's ability to sign the informed consent
- Participation in an interventional clinical study or planned participation during
study up to 12 months post-radiotherapy