Familial_LPD: Familial B-cell Lymphoproliferative Disorders

• Sponsor: University of Haifa (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05718986
• Collaborator: Bnai Zion Medical Center (Other)
• Enrollment: 1,000
• Anticipated Duration (Months): 212

Study Details

Study Description

Brief Summary

This study investigates families with at least two cases of B-cell lymphoproliferative disorders (LPD), and evaluates the prevalence of LPD in families, the relationship between medical history, genetic factors, and the risk of familial LPD, and various clinical outcomes for these families in a multiethnic population of Jews and Arabs in Israel.

Condition or Disease	Intervention/Treatment	Phase
Lymphoproliferative Disorders; Premalignant; Monoclonal B-Cell Lymphocytosis; Chronic Lymphocytic Leukemia	Other: No intervention

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1000 participants
• Observational Model: Family-Based
• Time Perspective: Other
• Official Title: Epidemiology of Familial B-cell Lymphoproliferative Disorders
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2028
• Anticipated Study Completion Date: Dec 1, 2040

Arms and Interventions

Arm	Intervention/Treatment
Bnai Zion Medical Center Bnai Zion Medical Center	Other: No intervention; No intervention
Tel Aviv Sourasky Medical Center - Ichilov Hospital Tel Aviv Sourasky Medical Center - Ichilov Hospital	Other: No intervention; No intervention
Galil Medical Center Galil Medical Center	Other: No intervention; No intervention
Ziv Medical Center Ziv Medical Center	Other: No intervention; No intervention
Emek Medical Center Emek Medical Center	Other: No intervention; No intervention
Beilinson Hospital Beilinson Hospital	Other: No intervention; No intervention
Meir Medical Center Meir Medical Center	Other: No intervention; No intervention
Kaplan Medical Center Kaplan Medical Center	Other: No intervention; No intervention
Sheba Medical Center Sheba Medical Center	Other: No intervention; No intervention
Rambam Medical Center Rambam Medical Center	Other: No intervention; No intervention
Shaare Zdek Medical Center Shaare Zdek Medical Center	Other: No intervention; No intervention
Hadassah Medical Center Hadassah Medical Center	Other: No intervention; No intervention
Shamir Medical Center (Assaf Harofeh) Shamir Medical Center (Assaf Harofeh)	Other: No intervention; No intervention
Soroka Medical Center Soroka Medical Center	Other: No intervention; No intervention
Assuta Ashdod Hospital Assuta Ashdod Hospital	Other: No intervention; No intervention

Outcome Measures

Primary Outcome Measures

1. Prevalence of familial LPD in Israel [5 years]

2. Association between medical history and genetic variants and the risk of familial LPD [5 years]

3. Risk of clinical outcomes among familial LPD and family members [15 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patient inclusion criteria:

Patients must have LPD and must have a family history of LPD. LPD patients who signed an informed consent to participate in the study.

Criteria for the inclusion of relatives of patients:

Relatives must be related by blood to LPD patients or unrelated (for control group).

Relatives who signed an informed consent to participate in the study.

Exclusion Criteria:

• Pregnant women, special populations and those lacking judgment will not be included

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Haifa
• Bnai Zion Medical Center

Investigators

• Principal Investigator: Geffen Kleinstern, PhD, University of Haifa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Geffen Kleinstern, Senior Lecturer, University of Haifa
• ClinicalTrials.gov Identifier: NCT05718986
• Other Study ID Numbers: FamilialLPD
• First Posted: Feb 8, 2023
• Last Update Posted: Feb 8, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Geffen Kleinstern, Senior Lecturer, University of Haifa: lymphoproliferative disorders; Chronic Lymphocytic Leukemia; Monoclonal B-cell Lymphocytosis
• Additional relevant MeSH terms: Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Precancerous Conditions; Lymphoproliferative Disorders; Lymphocytosis; Disease

Study Results

No Results Posted as of Feb 8, 2023