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.
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 breast reconstruction. However, in France, most patients with invasive breast carcinoma and treated with mastectomy are not offered immediate reconstruction. One reason is the need for postoperative radiotherapy for most patients (40 to 70% according to the centers). Indeed, radiotherapy induces side-effects which can alter the cosmetic result of the breast reconstruction as well as the patient's quality of life. Since 1995, a significant correlation is observed between the RILA test (measurement by flux cytometry of the lymphocyte T-CD8 apoptosis induced by radiotherapy) and the risk of occurrence of severe radio-induced breast fibrosis. Such accurate personalized medical care could allow identifying before any treatment high risk of toxicity patients and thus help establishing the therapeutic strategy. Identification of low-risk patients could also allow limiting autologous samplings and thus their associated morbidity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
250
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.
Centre Georges François Leclerc
Dijon, France
RECRUITINGCentre Oscar Lambret
Lille, France
RECRUITINGCentre Léon Bérard
Lyon, France
Ability of a radiosensitivity test to predict capsular contracture
To identify the Area Under the Curve (AUC) of the radiosensitive predictive test of Grade 3-4 capsular contracture
Time frame: 12 months after the end of radiotherapy
Capsular contracture prevalence
Rate of capsular contracture after radiotherapy
Time frame: 12 Months
Accuracy of the dichotomized test based on the optimal threshold
Accuracy of the test assessed by Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value
Time frame: 12 months
Precision of the radiosensitivity predictive test
Using the time dependant AUC (AUCt) method
Time frame: 12 months
Biological prognostics factors for capsular contracture occurence
Number and type of different biological prognostic factors of capsular contracture occurence
Time frame: 12 months
Tumoral prognostics factors for capsular contracture occurence
Number and type of different tumoral prognostic factors of capsular contracture occurence
Time frame: 12 months
Success of each surgical strategy in terms of deposit
Number of deposit according to each reconstruction surgery (one or two step)
Time frame: 24 months
Cosmetic outcomes measure
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Institut Paoli Calmette
Marseille, France
RECRUITINGInstitut du Cancer de Montpellier
Montpellier, France
RECRUITINGcentre Antoine Lacassagne
Nice, France
RECRUITINGHôpital Tenon
Paris, France
RECRUITINGInstitut de Cancérologie de l'Ouest
Saint-Herblain, France
RECRUITINGInstitut Claudius Regaud
Toulouse, France
RECRUITINGCosmetic questionnaire : BREAST-Q
Time frame: 6, 12, 18 and 24 months
Functional outcomes measure
Functional questionnaire: BREAST-Q
Time frame: 6, 12, 18 and 24 months
Patient satisfaction measure
Patient satisfaction questionnaire: BREAST-Q
Time frame: 6, 12, 18 and 24 months
General quality of life measure
Quality of life questionnaire: QLQ-C30
Time frame: 6, 12, 18 and 24 months
Specific quality of life measure for breast cancer patient
Quality of life questionnaire for breast cancer patient: QLQ-BR23
Time frame: 6, 12, 18 and 24 months
Stability of the test after chemotherapy
Test score at 12 months after the end of radiotherapy
Time frame: 12 months