Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction (PRETORIA)
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- STATUS
- Recruiting
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- End date
- Jun 5, 2027
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- participants needed
- 250
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- sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
Summary
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.
Description
Immediate reconstruction after mastectomy may help women with breast cancer to deal with their fear of mastectomy, spare them one or more second surgery and additional hospital stays in case of late breast reconstruction. However, in France, most patients with invasive breast carcinoma and treated with mastectomy are not offered immediate reconstruction. One reason is the need for postoperative radiotherapy for most patients (40 to 70% according to the centers). Indeed, radiotherapy induces side-effects which can alter the cosmetic result of the breast reconstruction as well as the patient's quality of life. Since 1995, a significant correlation is observed between the RILA test (measurement by flux cytometry of the lymphocyte T-CD8 apoptosis induced by radiotherapy) and the risk of occurrence of severe radio-induced breast fibrosis. Such accurate personalized medical care could allow identifying before any treatment high risk of toxicity patients and thus help establishing the therapeutic strategy. Identification of low-risk patients could also allow limiting autologous samplings and thus their associated morbidity.
Details
| Condition | Breast Cancer, Capsular Contracture Associated With Breast Implant |
|---|---|
| Treatment | NovaGray RILA Breast® test |
| Clinical Study Identifier | NCT04342546 |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle |
| Last Modified on | 5 July 2022 |
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