Immune Biomarkers, Genetic Risk, and the Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,500
- 主要终点
- Assess the relationship between LC MBL and cardiovascular diseases, autoimmune conditions, and Alzheimer among Jews and Arabs in Israel
研究概览
简要总结
The aim of this proposal is to identify immune biomarkers, genetic risk, and the clinical consequences of low count monoclonal B-cell lymphocytosis (LC MBL), a common premalignant condition affecting up to 17% of European adults age>40. LC MBL is a precursor to chronic lymphocytic leukemia (CLL), characterized by a circulating population of clonal B-cells. It is relatively understudied, despite emerging evidence of clinical consequences such as increased risk for life-threatening infections and lymphoid malignancies. Studies reported that male sex, age, family history of CLL, and CLL-susceptibility genetic loci were associated with LC MBL risk. These findings were reported in European ancestry individuals and have not been generalized to other thnicities. This study will provide this missing knowledge using a unique multi-ethnic Israeli population of Jews and Arabs that have one of the highest and lowest age-standardized incidence rates of CLL in the world, respectively, and characterized with different genetic backgrounds.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals over the age pf 40
排除标准
- •Individuals with lymphoproliferative disorder
结局指标
主要结局
Assess the relationship between LC MBL and cardiovascular diseases, autoimmune conditions, and Alzheimer among Jews and Arabs in Israel
时间窗: From enrollment and 15 years of follow up
Blood samples will be screened for MBL using flow cytometry, while data on the various outcomes will be collected from electronic medical records from Clalit Health Services.
Assess the relationship between LC MBL and life-threatening infections, hematologic malignancies, and solid tumors among Jews and Arabs in Israel
时间窗: From enrollment and 15 years of follow up
Blood samples will be screened for MBL using flow cytometry, while data on the various outcomes will be collected from electronic medical records from Clalit Health Services.
Identify germline genetic factors that are associated with LC MBL risk among Jews and Arabs in Israel
时间窗: The first 5 years of the study
DNA will be extracted from the blood sample and sequenced.
Evaluate the prevalence of LC MBL by Jews and Arabs and by sex in Israel.
时间窗: The first 5 years of the study
Blood samples will be screened for MBL using flow cytometry, ethnicity and sex will be determined using a demographic questionnaire
Identify immune biomarkers that are associated with LC MBL risk
时间窗: The first 5 years of the study
Blood sample will be screened for MBL using flow cytometry, and immune biomarkers will be screened from plasma samples.
次要结局
- Assess the relationship between LC MBL and other clinical conditions(From enrollment and 15 years of follow up)
研究者
Geffen Kleinstern
Senior Lecturer
University of Haifa