Prospective Evaluation of a Predictive Toxicity Test Post Radiotherapy After Mastectomy With Immediate Implant Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 9
- 主要终点
- Ability of a radiosensitivity test to predict capsular contracture
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: NovaGray RILA Breast® test (Device)
结局指标
主要结局
Ability of a radiosensitivity test to predict capsular contracture
时间窗: 12 months after the end of radiotherapy
To identify the Area Under the Curve (AUC) of the radiosensitive predictive test of Grade 3-4 capsular contracture
次要结局
- Precision of the radiosensitivity predictive test(12 months)
- Tumoral prognostics factors for capsular contracture occurence(12 months)
- General quality of life measure(6, 12, 18 and 24 months)
- Biological prognostics factors for capsular contracture occurence(12 months)
- Cosmetic outcomes measure(6, 12, 18 and 24 months)
- Functional outcomes measure(6, 12, 18 and 24 months)
- Patient satisfaction measure(6, 12, 18 and 24 months)
- Stability of the test after chemotherapy(12 months)
- Capsular contracture prevalence(12 Months)
- Success of each surgical strategy in terms of deposit(24 months)
- Specific quality of life measure for breast cancer patient(6, 12, 18 and 24 months)
- Accuracy of the dichotomized test based on the optimal threshold(12 months)