Recruiting
Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
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.
ClinicalTrials.gov IDNCT04342546
PhaseNA
Enrollment250
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
Age18 Years
SexMALE
Conditions studied
Breast Cancer, Capsular Contracture Associated With Breast Implant
About this study
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.
Interventions
- Device: NovaGray RILA Breast® test — The test consists of a blood sample of 2x4 mL. This test will be performed between day -30 and until the first day of radiotherapy (before the start of this one) and then 12 months after the end of radiotherapy and between day -30 and until the first day of chemotherapy (before any injection) in the case of neoadjuvant chemotherapy and between day -30 and until the first day of chemotherapy (before any injection) in the case of adjuvant chemotherapy.
Primary outcomes
- Ability of a radiosensitivity test to predict capsular contracture (12 months after the end of radiotherapy)
Eligibility information
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
Exclusion Criteria:
* 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
Study locations
- Centre Georges François Leclerc, Dijon, 21079 France
- Centre Oscar Lambret, Lille, 59000 France
- Centre Léon Bérard, Lyon, 69373 France
- Institut Paoli Calmette, Marseille, 13009 France
- Institut du Cancer de Montpellier, Montpellier, 34298 France
- centre Antoine Lacassagne, Nice, 06189 France
- Hôpital Tenon, Paris, 75970 France
- Institut de Cancérologie de l'Ouest, Saint-Herblain, 44805 France
- Institut Claudius Regaud, Toulouse, 31059 France
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.