Immunological Repertoire in Patients With Lymphoma and Chronic Lymphocytic Leukemia, Biomedical Research on Medical Devices Human ImmunTracker and Human Immun'IgH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- change in variations of the T and B cell repertoire in patients with lymphoid blood disease under treatment
研究概览
简要总结
RIPAL is a prospective cohort study, which main goal is to define T and B immune repertoire diversity and magnitude in patients with non-Hodgkin lymphoma of high and low grade and chronic lymphocytic leukemia before and after treatment, and to evaluate the association of these parameters with clinical patient data and outcomes.
详细描述
Constitution of a prospective cohort of 128 patients with 8 different groups of patients. This protocol is designed to evaluate a new tool for detecting the diversity of the repertoire T and B in patients with hematological disease. This in vitro diagnostic device is consisting of molecular biology kits Human ImmunTraCkeR® and Human Immun'IgH® and the analysis tool NDL®
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
- •18 Years and older
- •Subjects with a diagnosis of large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, MALT, marginal zone, Waldenstrom's disease, chronic lymphocytic leukemia, T-cell lymphoma, anaplastic, cytotoxic or peripheral unspecified angioimmunoblastic.
- •Have signed an informed consent for participation in the study and preservation of blood samples for biomedical research.
- •Accept to appear in consultation biological samples at the sampling points corresponding to its group.
- •The benefits of social security.
排除标准
- •Subjects with a diagnosis of Hodgkin disease
- •Subjects with a diagnosis of T-prolymphocytic leukemia
- •Subjects with a diagnosis of Burkitt's lymphoma
- •Subjects with a diagnosis of lymphoblastic lymphoma
- •Subjects who had prior-treatment for hematological disease
- •Patients under judicial safeguards
结局指标
主要结局
change in variations of the T and B cell repertoire in patients with lymphoid blood disease under treatment
时间窗: from D0 to 18 months
results given by the technical Immun'IgH® Human and Human ImmunTraCkeR® and score NDL® The 2 criteria for obtaining the data are the diversity and intensity of the immune repertoire: The intensity of the signal corresponds to the frequency of VJ rearrangements detected in the samples. It is expressed in Arbitrary Units. The diversity corresponds to the number of different VJ rearrangements detected compared to all theoretical VJ rearrangement. It is expressed in percentage.
次要结局
- performance of the mapping of the immune repertoire to predict treatment response(from D0 to 18 months)
- performance of the mapping of the immune repertoire to predict the risk of infection(from D0 to 18 months)
- sensitivity of detection of the circulating clones(from D0 to 18 months)
- performance of the mapping of the immune repertoire to predict progression free survival(from D0 to progression)