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

NCT06416267 | Not Yet Recruiting

• 1 other identifier: MBL_RiskCons
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

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

Keywords

Monoclonal B cell Lymphocytosis; Genetic Risk; Outcomes; Infections; Cancers; CLL

Outcome Measures

Primary Outcomes (5)

• Assess the relationship between LC MBL and life-threatening infections, hematologic malignancies, and solid tumors among Jews and Arabs in Israel

  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.

  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

  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.

  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

  DNA will be extracted from the blood sample and sequenced.

  The first 5 years of the study

• Evaluate the prevalence of LC MBL by Jews and Arabs and by sex in Israel.

  Blood samples will be screened for MBL using flow cytometry, ethnicity and sex will be determined using a demographic questionnaire

  The first 5 years of the study

• Identify immune biomarkers that are associated with LC MBL risk

  Blood sample will be screened for MBL using flow cytometry, and immune biomarkers will be screened from plasma samples.

  The first 5 years of the study

Secondary Outcomes (1)

• Assess the relationship between LC MBL and other clinical conditions

  From enrollment and 15 years of follow up

Study Arms (1)

Clalit Health Services

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Individuals over the age pf 40

You may not qualify if:

• Individuals with lymphoproliferative disorder

Sponsors & Collaborators

• University of Haifa: lead
• Clalit Health Services, Haifa and West Galilee: collaborator
• Bnai Zion Medical Center: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Infections; Neoplasms; Cardiovascular Diseases; Alzheimer Disease; Dementia; Autoimmune Diseases; Parkinson Disease

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Central Study Contacts

Geffen Kleinstern

CONTACT

+972545715624; gkleinste@univ.haifa.ac.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 16, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2040
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share