Feasibility Study on the Characterization of the Immune Profile of Young Patients After Treatment for Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Identification of the relevant biological parameters of the innate / adaptive immune system
研究概览
简要总结
This study aim to determine kinetic of post treatment recovery/variation of a panel of innate and adaptative immune system cells and molecules.
The results should allow to determine the optimal post treatment immunomonitoring timing and panel to be used for future studies.
详细描述
There is a complexe interaction between tumor cells ans host immunity. Immunity system (IS) is clearly involved in cancer developement control, and it is suggested that it could participate to the response to anti cancer treatment.
There is however no validated immunomonitoring strategy to allow a reliable patient's immune status along time, and particularly after treatment.There are scarce existing information on immunologic reconstitution profile recovery after treatment.
This study aim to perform immunomonitoring in young patients with cancer to describe kinetic of recovery/variation of a panel of innate and adaptative immune system cells and molecules, selected by their potential relevance according to literature.
The concerned population are young women (˂40 yo) with breast cancer.
There will be 2 patients cohorts A or "End of treatment" : patients recruited at the end of treatment (study cohort) B or "Diagnosis" : Patients recruited at diagnosis (reference values)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with Breast cancer at initial diagnosis OR at the end of treatment
- •Chemotherapy planned or performed in the treatment plan
- •Patient not opposed to participate to the present study
- •Affiliated to a French social security scheme.
排除标准
- •metastatic breast cancer
- •pregnant or breastfeeding woman
- •Treatment with monoclonal antibodies or immunotherapy
- •Immunosuppressive therapy
- •Thymus irradiation
- •Chronic infection in progress
- •Inborn or acquired disease (other than breast cancer) impacting the immune system (SAA, Lupus...)
- •Subject under guardianship or deprived of liberty
结局指标
主要结局
Identification of the relevant biological parameters of the innate / adaptive immune system
时间窗: 15 months
Analysis of immune profile implies to evaluate changes of about 30 distinct immune cell (sub)types with their activation markers. These analyses are conducted at 3 time points for cohort "A or End of treatment" (1, 5, 9 months) and once for cohort "B or Diagnosis" before treatment start : -% and counts of immune cell populations (B-lymphocytes, T-lymphocytes, dendritic cells) * activation levels of cell subpopulations * Secretion of cytokines after activation * Determination of cytokines and chemokines after activation (picograms/ml) Description of the evolution of the parameters measured for cohort "A or End of treatment" with comparison to normal values (data from the EFS cohort and from cohort "B or Diagnosis") Analysis of the reconstitution kinetic should allow us to determine wich biological parameters (immune cell (sub)types and their activation markers) will be most relevant to study immune profile reconstitution for further studies.
次要结局
- Analysis feasibility(15 months)
- Immunity Cells and molecules kinetic analysis(15 months)