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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorUniversity of Haifa

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Individuals over the age pf 40

Disqualifiers

Individuals with lymphoproliferative disorder

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,500 Participants
are grouped into 1 trial group
Group A: Clalit Health Services

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment and 15 years of follow up
2

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.

Time frame
From enrollment and 15 years of follow up
3

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.

Time frame
The first 5 years of the study
4

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

Time frame
The first 5 years of the study

Secondary outcomes

1

Assess the relationship between LC MBL and other clinical conditions

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

Time frame
From enrollment and 15 years of follow up

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Haifa

Lead sponsor

Clalit Health Services, Haifa and West Galilee

Collaborator

Bnai Zion Medical Center

Collaborator

This trial is not recruiting at the moment. You can still explore other options: