Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruc… (NCT04342546) | Clinical Trial Compass
RecruitingNot Applicable
Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
France250 participantsStarted 2020-12-11
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Ability of a radiosensitivity test to predict capsular contracture
Timeframe: 12 months after the end of radiotherapy
Trial details
NCT IDNCT04342546
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle