Alzheimer Disease, Autoimmune Diseases, Cancers, Cardiovascular Diseases, Chronic Lymphocytic Leukemia, Dementia, Infections, Monoclonal B-Cell Lymphocytosis, Parkinson Disease
Conditions
Keywords
Monoclonal B cell Lymphocytosis, Genetic Risk, Outcomes, Infections, Cancers, CLL
Brief summary
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.
Interventions
None listed
Sponsors
Clalit Health Services, Haifa and West Galilee
Bnai Zion Medical Center
University of Haifa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Individuals over the age pf 40
Exclusion criteria
* Individuals with lymphoproliferative disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the relationship between LC MBL and life-threatening infections, hematologic malignancies, and solid tumors among Jews and Arabs in Israel | 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 cardiovascular diseases, autoimmune conditions, and Alzheimer among Jews and Arabs in Israel | 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 | 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. | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the relationship between LC MBL and other clinical conditions | From enrollment and 15 years of follow up | Other clinical conditions will be determined from electronic medical records from Clalit Health Services |
Contacts
Primary ContactGeffen Kleinstern
Outcome results
None listed