## Protocol Section
### Identification Module
**NCT ID:** NCT06416267

**Acronym:** MBL RiskConseq

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

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

#### Organization Study ID Info
**ID:** MBL_RiskCons
#### Organization
**Class:** OTHER
**Full Name:** University of Haifa
### Status Module
#### Completion Date
**Date:** 2040-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2040-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Clalit Health Services, Haifa and West Galilee

**Class:** OTHER_GOV

**Name:** Bnai Zion Medical Center

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Haifa

#### Responsible Party

**Investigator Affiliation:** University of Haifa

**Investigator Full Name:** Geffen Kleinstern

**Investigator Title:** Senior Lecturer

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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\&amp;gt;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 Module

**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

### Design Module

#### Bio Spec

**Description:** Blood samples

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1500

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Label:** Clalit Health Services

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**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

**Description:** 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.

**Measure:** 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

**Description:** DNA will be extracted from the blood sample and sequenced.

**Measure:** 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

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

**Measure:** Evaluate the prevalence of LC MBL by Jews and Arabs and by sex in Israel.

**Time Frame:** The first 5 years of the study

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

**Measure:** Identify immune biomarkers that are associated with LC MBL risk

**Time Frame:** The first 5 years of the study

#### Secondary Outcomes

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

**Measure:** Assess the relationship between LC MBL and other clinical conditions

**Time Frame:** From enrollment and 15 years of follow up

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Individuals over the age pf 40

Exclusion Criteria:

* Individuals with lymphoproliferative disorder

**Healthy Volunteers:** True

**Minimum Age:** 40 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** gkleinste@univ.haifa.ac.il

**Name:** Geffen Kleinstern

**Phone:** +972545715624

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020734

- Term: Parkinsonian Disorders

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009069

- Term: Movement Disorders

- ID: D000080874

- Term: Synucleinopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000003704

- Term: Dementia

- ID: D000024801

- Term: Tauopathies

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000007945

- Term: Leukemia, Lymphoid

- ID: D000007938

- Term: Leukemia

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

- ID: D000015448

- Term: Leukemia, B-Cell

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000007964

- Term: Leukocytosis

- ID: D000007960

- Term: Leukocyte Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13213

- Name: Parkinson Disease

- Relevance: HIGH

- As Found: Parkinson's Disease

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6904

- Name: Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: HIGH

- As Found: Autoimmune Diseases

- ID: M3885

- Name: Alzheimer Disease

- Relevance: HIGH

- As Found: Alzheimer's Disease

- ID: M10945

- Name: Leukemia

- Relevance: LOW

- As Found: Unknown

- ID: M10951

- Name: Leukemia, Lymphoid

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M18116

- Name: Leukemia, Lymphocytic, Chronic, B-Cell

- Relevance: HIGH

- As Found: Chronic Lymphocytic Leukemia

- ID: M11215

- Name: Lymphocytosis

- Relevance: HIGH

- As Found: Lymphocytosis

- ID: M22494

- Name: Parkinsonian Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2217

- Name: Synucleinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23002

- Name: Tauopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M18115

- Name: Leukemia, B-Cell

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M10967

- Name: Leukocytosis

- Relevance: LOW

- As Found: Unknown

- ID: M10963

- Name: Leukocyte Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T2192

- Name: Familial Alzheimer Disease

- Relevance: LOW

- As Found: Unknown

- ID: T1308

- Name: Chronic Lymphocytic Leukemia

- Relevance: HIGH

- As Found: Chronic Lymphocytic Leukemia

### Condition Browse Module - Meshes

- ID: D000015451

- Term: Leukemia, Lymphocytic, Chronic, B-Cell

- ID: D000010300

- Term: Parkinson Disease

- ID: D000000544

- Term: Alzheimer Disease

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000008218

- Term: Lymphocytosis

- ID: D000001327

- Term: Autoimmune Diseases

### Misc Info Module

- Version Holder: 2024-05-31
