Clinical trial NCT06416267: Risk and Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL)
Official title: Immune Biomarkers, Genetic Risk, and the Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Monoclonal B-Cell Lymphocytosis
Chronic Lymphocytic Leukemia
Infections
Cancers
Cardiovascular Diseases
Alzheimer Disease
Dementia
Autoimmune Diseases
Parkinson Disease
Keywords: Monoclonal B cell Lymphocytosis
Genetic Risk
Outcomes
Infections
Cancers
CLL
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Clalit Health Services, Haifa and West Galilee
name: Bnai Zion Medical Center
First posted: 2024-05-16
Enrollment: 1500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Jewish and Arab individuals over the age of 40 attending to the Clalit HMO clinics in the North of Israel for regular blood tests

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\&amp;gt;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.


Eligibility criteria: Inclusion Criteria:

* Individuals over the age pf 40

Exclusion Criteria:

* Individuals with lymphoproliferative disorder

Primary outcomes:
measure: Assess the relationship between LC MBL and life-threatening infections, hematologic malignancies, and solid tumors among Jews and Arabs in Israel
timeFrame: From enrollment and 15 years of follow up
measure: Assess the relationship between LC MBL and cardiovascular diseases, autoimmune conditions, and Alzheimer among Jews and Arabs in Israel
timeFrame: From enrollment and 15 years of follow up
measure: Identify germline genetic factors that are associated with LC MBL risk among Jews and Arabs in Israel
timeFrame: The first 5 years of the study
measure: Evaluate the prevalence of LC MBL by Jews and Arabs and by sex in Israel.
timeFrame: The first 5 years of the study
measure: Identify immune biomarkers that are associated with LC MBL risk
timeFrame: The first 5 years of the study
Secondary outcomes:
measure: Assess the relationship between LC MBL and other clinical conditions
timeFrame: From enrollment and 15 years of follow up
Other outcomes:
Locations:
Study officials:
References: