Bringing Semi-quantitative PET-TDM FDG Data and Texture Analysis to Clinical, Histological and Immuno-histochemical Characteristics of Primary Mammary Tumors Triple Negatives
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Assess the prognostic value of the texture parameters of PET-TDM FDG on event-free survival at 2 years.
研究概览
简要总结
"Triple Negative" breast cancers are a heterogeneous group characterized by the absence of hormone receptors to estrogen, progesterone and the absence of expression or amplification of the HER-2 gene. This type of cancer is associated with an adverse clinical profile with a high risk of early metastatic relapse. Accurate identification of prognostic factors, as well as predictors of therapeutic response, and the contribution of targeted therapies are avenues for improving the management and survival of patients with these cancers. Such an approach requires optimal biological characterization, allowing us to understand the complexity of this group of tumors, and requires multidisciplinary collaboration in clinical trials involving anatomopathology, oncology and morpho-functional imaging.
The investigator's goal is to characterize by innovative methods (anatomo-pathological in particular Of Immunohistochemistry, and morpho-functional imaging (TEP-TDM FDG) semi-quantitative and texture) in a population of Triple Negative Breast Cancer scans better knowledge of this entity that can lead to the development of relevant therapeutic strategies and especially more adapted in the context of precision and personalized medicine.
详细描述
120 consecutive patients with "Triple Negative" breast cancers operatable from the outset will be included in the study
- To assess the prognostic value of the texture parameters of PET-TDM FDG on event-free survival at 2 years.
- To assess the prognostic value of standard parameters (clinical, standard histology, conventional imaging), semi-quantitative PET-TDM FDG and innovative Immuno-histochemistry parameters for 2-year event-free survival .
- To assess correlations between continuous PET-TDM FDG texture parameters and Immuno-histochemistry.
- To assess the multivariate prognostic value of standard parameters, PET-TDM FDG imaging parameters and Immuno-histochemistry defined as relevant to 2-year event-free survival .
- Construction of an optimal prognostic nomogram combining independent parameters to isolate different prognostic subgroups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with biopsy-proven triple-negative breast cancer, newly diagnosed, naïve from any treatment.
- •Performance Status (PS) : 0 or
- •No metastasis on the extension balance.
- •Treatment provided immediately by lumpectomy or mastectomy, and accepted by the patient.
排除标准
- •Severe illness or comorbidity at risk.
- •A history of cancer within 5 years, with the exception of skin carcinomas (other than melanoma) or in-situ cervical carcinomas.
- •Patient candidate for neo-adjuvant therapy.
结局指标
主要结局
Assess the prognostic value of the texture parameters of PET-TDM FDG on event-free survival at 2 years.
时间窗: 2 years
The 2-year event-free survival rate based on the texture parameters of the PET-TDM FDG. Event free survival is the duration between the date of diagnosis and the date of the first event (relapse, death) or the date of the last news without event.
次要结局
- Construction of an optimal prognostic nomogram combining independent parameters to isolate different prognostic subgroups(2 years)
- assess the multivariate prognostic value of standard parameters, PET-TDM FDG imaging parameters and Immunohistochemistry defined as relevant to 2-year event-free survival(2 years)
- To assess the correlations between continuous texture parameters in PET-TDM FDG and Immunohistochemistry.(2 years)
- assess the prognostic value of standard parameters (clinical, standard histology, conventional imaging), semi-quantitative PET-TDM FDG and innovative Immunohistochemistry parameters for 2-year event-free survival .(2 years)