Risk and Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL)

Sponsor
University of Haifa
Study ID
NCT06416267
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
May 16, 2024
Start date
Aug 31, 2024
Status verified
May 2024
Primary completion
Dec 31, 2040
Completion
Dec 31, 2040

Study Design

Enrollment
1,500 participants (estimated)

Arms

  • Arm: Clalit Health Services
    Individuals over the age of 40 attending to the Clalit HMO clinics in the North of Israel for regular blood tests.

Primary Outcome Measure

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 ]

Central Contacts

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