Risk and Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Monoclonal B-Cell Lymphocytosis, Chronic Lymphocytic Leukemia, Infections, Cancers. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Immune Biomarkers, Genetic Risk, and the Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL)
Overview
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.
Primary outcome measures
- Assess the relationship between LC MBL and life-threatening infections, hematologic malignancies, and solid tumors among Jews and Arabs in Israel [Time frame: From enrollment and 15 years of follow up]
- Assess the relationship between LC MBL and cardiovascular diseases, autoimmune conditions, and Alzheimer among Jews and Arabs in Israel [Time frame: From enrollment and 15 years of follow up]
- Identify germline genetic factors that are associated with LC MBL risk among Jews and Arabs in Israel [Time frame: The first 5 years of the study]
- Evaluate the prevalence of LC MBL by Jews and Arabs and by sex in Israel. [Time frame: The first 5 years of the study]
- Identify immune biomarkers that are associated with LC MBL risk [Time frame: The first 5 years of the study]
Secondary outcome measures (1)
- Assess the relationship between LC MBL and other clinical conditions [Time frame: From enrollment and 15 years of follow up]
Eligibility criteria
Inclusion criteria
- Individuals over the age pf 40
Exclusion criteria
- Individuals with lymphoproliferative disorder
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06416267 · MBL_RiskCons