Prospective Evaluation of a Predictive Toxicity Test Post Radiotherapy After Mastectomy With Immediate Implant Reconstruction
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
Centre Georges François Leclerc
RECRUITING
Dijon
Centre Oscar Lambret
RECRUITING
Lille
Centre Léon Bérard
RECRUITING
Lyon
Institut Paoli Calmette
RECRUITING
Marseille
Institut du Cancer de Montpellier
RECRUITING
Montpellier
centre Antoine Lacassagne
RECRUITING
Nice
Hôpital Tenon
RECRUITING
Paris
Institut de Cancérologie de l'Ouest
RECRUITING
Saint-herblain
Institut Claudius Regaud
RECRUITING
Toulouse
Contact Information
Primary
Aurore MOUSSION
DRCI-icm105@icm.unicancer.fr
04 67 61 31 02
Backup
Emmanuelle TEXIER
DRCI-icm105@icm.unicancer.fr
04 67 61 31 02
Time Frame
Start Date: 2020-12-11
Estimated Completion Date: 2027-06
Participants
Target number of participants: 250
Treatments
Experimental: Toxicity test
For all patients, the NovaGray RILA Breast® 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 in the case of neoadjuvant chemotherapy, between day -30 and until the first day of chemotherapy (before any injection) and in the case of adjuvant chemotherapy, between day -30 and until the first day of chemotherapy (before any injection).~The test consists of a blood sample of 2x4 mL
Related Therapeutic Areas
Sponsors
Leads: Institut du Cancer de Montpellier - Val d'Aurelle