NCT04342546 Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
| NCT ID | NCT04342546 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2020-12-11 |
| Primary Completion | 2029-12-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2020-12-11 with a primary completion date of 2029-12-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Marian Gutowski
STUDY CHAIR
Institut du Cancer de Montpellier - Val d'Aurelle
Frequently Asked Questions
Who can join the NCT04342546 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04342546 currently recruiting?
Yes, NCT04342546 is actively recruiting participants. Contact the research team at DRCI-icm105@icm.unicancer.fr for enrollment information.
Where is the NCT04342546 trial being conducted?
This trial is being conducted at Dijon, France, Lille, France, Lyon, France, Marseille, France and 5 additional locations.
Who is sponsoring the NCT04342546 clinical trial?
NCT04342546 is sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. The principal investigator is Marian Gutowski at Institut du Cancer de Montpellier - Val d'Aurelle. The trial plans to enroll 250 participants.
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