Status:
RECRUITING
Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Breast Cancer
Capsular Contracture Associated With Breast Implant
Eligibility:
MALE
18+ years
Phase:
NA
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.
Detailed 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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04342546
Start Date
December 11 2020
End Date
June 1 2027
Last Update
November 5 2024
Active Locations (9)
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1
Centre Georges François Leclerc
Dijon, France, 21079
2
Centre Oscar Lambret
Lille, France, 59000
3
Centre Léon Bérard
Lyon, France, 69373
4
Institut Paoli Calmette
Marseille, France, 13009