Ireland
--:--IST
Recruiting Not applicable

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

NCT04342546 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2020-12-11
Last updated
2026-04-13

Condition(s) studied

Breast CancerCapsular Contracture Associated With Breast Implant

Investigational drug(s) / intervention(s)

NovaGray RILA Breast® test

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.

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Ability of a radiosensitivity test to predict capsular contracture — 12 months after the end of radiotherapy
    To identify the Area Under the Curve (AUC) of the radiosensitive predictive test of Grade 3-4 capsular contracture

Trial sites (9)

FacilityCityRegionStatus
Centre Georges François Leclerc Dijon France Recruiting
Centre Oscar Lambret Lille France Recruiting
Centre Léon Bérard Lyon France Recruiting
Institut Paoli Calmette Marseille France Recruiting
Institut du Cancer de Montpellier Montpellier France Recruiting
centre Antoine Lacassagne Nice France Recruiting
Hôpital Tenon Paris France Recruiting
Institut de Cancérologie de l'Ouest Saint-Herblain France Recruiting
Institut Claudius Regaud Toulouse France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04342546 on ClinicalTrials.gov ↗ ← All trials in France