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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02178-49 | Registry Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toxicity test | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NovaGray RILA Breast® test | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months after the end of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Capsular contracture prevalence | Rate of capsular contracture after radiotherapy | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients with breast cancer treated by mastectomy with immediate implant breast reconstruction
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurore MOUSSION | Contact | 04 67 61 31 02 | +33 | DRCI-icm105@icm.unicancer.fr |
| Emmanuelle TEXIER | Contact | 04 67 61 31 02 | +33 | DRCI-icm105@icm.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marian Gutowski | Institut du Cancer de Montpellier - Val d'Aurelle | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges François Leclerc | Recruiting | Dijon | 21079 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31383624 | Background | Negre G, Balcaen T, Dast S, Sinna R, Chazard E. Breast reconstruction in France, observational study of 140,904 cases of mastectomy for breast cancer. Ann Chir Plast Esthet. 2020 Feb;65(1):36-43. doi: 10.1016/j.anplas.2019.07.014. Epub 2019 Aug 2. | |
| 25003439 | Background | Ng SK, Hare RM, Kuang RJ, Smith KM, Brown BJ, Hunter-Smith DJ. Breast Reconstruction Post Mastectomy: Patient Satisfaction and Decision Making. Ann Plast Surg. 2016 Jun;76(6):640-4. doi: 10.1097/SAP.0000000000000242. |
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For all the 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.
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|
| 12 months |
| Precision of the radiosensitivity predictive test | Using the time dependant AUC (AUCt) method | 12 months |
| Biological prognostics factors for capsular contracture occurence | Number and type of different biological prognostic factors of capsular contracture occurence | 12 months |
| Tumoral prognostics factors for capsular contracture occurence | Number and type of different tumoral prognostic factors of capsular contracture occurence | 12 months |
| Success of each surgical strategy in terms of deposit | Number of deposit according to each reconstruction surgery (one or two step) | 24 months |
| Cosmetic outcomes measure | Cosmetic questionnaire : BREAST-Q | 6, 12, 18 and 24 months |
| Functional outcomes measure | Functional questionnaire: BREAST-Q | 6, 12, 18 and 24 months |
| Patient satisfaction measure | Patient satisfaction questionnaire: BREAST-Q | 6, 12, 18 and 24 months |
| General quality of life measure | Quality of life questionnaire: QLQ-C30 | 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 | 6, 12, 18 and 24 months |
| Stability of the test after chemotherapy | Test score at 12 months after the end of radiotherapy | 12 months |
| Centre Oscar Lambret | Recruiting | Lille | 59000 | France |
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| Centre Léon Bérard | Recruiting | Lyon | 69373 | France |
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| Institut Paoli Calmette | Recruiting | Marseille | 13009 | France |
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| Institut du Cancer de Montpellier | Recruiting | Montpellier | 34298 | France |
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| centre Antoine Lacassagne | Recruiting | Nice | 06189 | France |
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| Hôpital Tenon | Recruiting | Paris | 75970 | France |
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| Institut de Cancérologie de l'Ouest | Recruiting | Saint-Herblain | 44805 | France |
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| Institut Claudius Regaud | Recruiting | Toulouse | 31059 | France |
|
| 27406255 | Background | Howes BH, Watson DI, Xu C, Fosh B, Canepa M, Dean NR. Quality of life following total mastectomy with and without reconstruction versus breast-conserving surgery for breast cancer: A case-controlled cohort study. J Plast Reconstr Aesthet Surg. 2016 Sep;69(9):1184-91. doi: 10.1016/j.bjps.2016.06.004. Epub 2016 Jun 18. |
| 15894097 | Background | Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0. |
| 28985836 | Background | Ricci JA, Epstein S, Momoh AO, Lin SJ, Singhal D, Lee BT. A meta-analysis of implant-based breast reconstruction and timing of adjuvant radiation therapy. J Surg Res. 2017 Oct;218:108-116. doi: 10.1016/j.jss.2017.05.072. Epub 2017 Jun 15. |
| 21336948 | Result | Barry M, Kell MR. Radiotherapy and breast reconstruction: a meta-analysis. Breast Cancer Res Treat. 2011 May;127(1):15-22. doi: 10.1007/s10549-011-1401-x. Epub 2011 Feb 20. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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