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Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction

RecruitingNAAges 18 Years - anyMaleInstitut du Cancer de Montpellier - Val d'Aurelle
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • NovaGray RILA Breast® test
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Where

9 sites
Centre Georges François Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmette
Marseille, France
Institut du Cancer de Montpellier
Montpellier, France
centre Antoine Lacassagne
Nice, France
Hôpital Tenon
Paris, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, France

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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