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NCT Number: NCT06416267

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

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.

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Key information

Conditions

Monoclonal B-Cell Lymphocytosis Alzheimer Disease Autoimmune Diseases Basal Ganglia Diseases Brain Diseases Cancers Cardiovascular Diseases Central Nervous System Diseases Chronic Disease Chronic Lymphocytic Leukemia Dementia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Mental Disorders Movement Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Synucleinopathies Tauopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals over the age pf 40

Exclusion criteria

  • Individuals with lymphoproliferative disorder

Treatment and study plan

Primary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    DNA will be extracted from the blood sample and sequenced.

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

    Time frame: The first 5 years of the study

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

  5. Identify immune biomarkers that are associated with LC MBL risk

    Time frame: The first 5 years of the study

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

Secondary outcomes

  1. Assess the relationship between LC MBL and other clinical conditions

    Time frame: From enrollment and 15 years of follow up

    Other clinical conditions will be determined from electronic medical records from Clalit Health Services

Study contacts

Contact information is provided by the study sponsor or research team.

Geffen Kleinstern

CONTACT

[email protected]

+972545715624

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Collaborators

  • Bnai Zion Medical Center
  • Clalit Health Services, Haifa and West Galilee

Registry information

Official study title

Immune Biomarkers, Genetic Risk, and the Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL)

Acronym: MBL RiskConseq

Important dates

Study start
2024
Primary completion
2040
Study completion
2040
First posted
May 16, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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