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

Cardiovascular Diseases Clinical Trial

— MBL RiskConseq  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06416267
• Other study ID #: MBL_RiskCons
• Status: Not yet recruiting
• Start date: August 2024
• Est. completion date: December 2040

Study information

• Verified date: May 2024
• Source: University of Haifa
• Contact: Geffen Kleinstern
• Phone: +972545715624
• Email: gkleinste[@]univ.haifa.ac.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: December 2040
• Est. primary completion date: December 2040
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Individuals over the age pf 40

Exclusion Criteria:

• Individuals with lymphoproliferative disorder

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Haifa	Bnai Zion Medical Center, Clalit Health Services, Haifa and West Galilee

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Assess the relationship between LC MBL and other clinical conditions	Other clinical conditions will be determined from electronic medical records from Clalit Health Services	From enrollment and 15 years of follow up