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

NCT ID: NCT06416267

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2040-12-31

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.

Conditions

Monoclonal B-Cell Lymphocytosis; Chronic Lymphocytic Leukemia; Infections; Cancers; Cardiovascular Diseases; Alzheimer Disease; Dementia; Autoimmune Diseases; Parkinson Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Clalit Health Services

Individuals over the age of 40 attending to the Clalit HMO clinics in the North of Israel for regular blood tests.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Individuals over the age pf 40

Exclusion Criteria

• Individuals with lymphoproliferative disorder

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clalit Health Services, Haifa and West Galilee

OTHER

Sponsor Role: collaborator

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role: collaborator

University of Haifa

OTHER

Sponsor Role: lead

Responsible Party

Geffen Kleinstern

Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Geffen Kleinstern

Role: CONTACT

gkleinste@univ.haifa.ac.il

+972545715624

Other Identifiers

MBL_RiskCons

Identifier Type: -

Identifier Source: org_study_id