Monoclonal B-Cell LymphocytosisMBL RiskConseqNCT06416267
Risk and Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL)
An observational study of Monoclonal B-Cell Lymphocytosis and Chronic Lymphocytic Leukemia, run by University of Haifa.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Monoclonal B-Cell Lymphocytosis, Chronic Lymphocytic Leukemia, Infections
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Individuals over the age pf 40
Who cannot join
- Individuals with lymphoproliferative disorder
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Immune Biomarkers, Genetic Risk, and the 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.
- Conditions
- Monoclonal B-Cell Lymphocytosis, Chronic Lymphocytic Leukemia, Infections, Cancers, Cardiovascular Diseases, Alzheimer Disease
- Keywords
- Monoclonal B cell Lymphocytosis, Genetic Risk, Outcomes, Infections, Cancers, CLL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Infections, Neoplasms, Cardiovascular Diseases, Alzheimer Disease, Dementia, Autoimmune Diseases, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clalit Health Services | Individuals over the age of 40 attending to the Clalit HMO clinics in the North of Israel for regular blood tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: From enrollment and 15 years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study startAug 2024 (estimated)
- Primary completionDec 2040 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal B-Cell LymphocytosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services, Haifa and West Galilee, Bnai Zion Medical Center
- Responsible party
- Principal investigator, Geffen Kleinstern, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416267
- Sponsor's protocol ID
- MBL_RiskCons
- Acronym
- MBL RiskConseq
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Biomarkers, Genetic Risk, and the Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL)
- ClinicalTrials.gov ID
- NCT06416267
- Acronym / sponsor ID
- MBL RiskConseq / MBL_RiskCons
- Conditions
- Monoclonal B-Cell Lymphocytosis, Chronic Lymphocytic Leukemia, Infections, Cancers, Cardiovascular Diseases, Alzheimer Disease
- Keywords
- Monoclonal B cell Lymphocytosis, Genetic Risk, Outcomes, Infections, Cancers, CLL
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Clalit Health Services, Haifa and West Galilee, Bnai Zion Medical Center
- Study start
- Aug 2024 (estimated)
- Primary completion
- Dec 2040 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clalit Health Services | – | –Individuals over the age of 40 attending to the Clalit HMO clinics in the North of Israel for regular blood tests. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Individuals over the age pf 40
Key exclusion criteria (1 listed)
- Individuals with lymphoproliferative disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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
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.
1 secondary outcome
Assess the relationship between LC MBL and other clinical conditions
Time frame: From enrollment and 15 years of follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Monoclonal B-Cell Lymphocytosis and Chronic Lymphocytic Leukemia, run by University of Haifa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geffen Kleinstern (+972545715624, gkleinste@univ.haifa.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.