NCT05718986

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
177mo left

Started Jun 2024

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Jun 2024Dec 2040

First Submitted

Initial submission to the registry

January 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
12 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2040

Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

4.5 years

First QC Date

January 30, 2023

Last Update Submit

May 7, 2024

Conditions

Keywords

lymphoproliferative disordersChronic Lymphocytic LeukemiaMonoclonal B-cell Lymphocytosis

Outcome Measures

Primary Outcomes (3)

  • Prevalence of familial LPD in Israel

    5 years

  • Association between medical history and genetic variants and the risk of familial LPD

    5 years

  • Risk of clinical outcomes among familial LPD and family members

    15 years

Study Arms (15)

Bnai Zion Medical Center

Bnai Zion Medical Center

Other: No intervention

Tel Aviv Sourasky Medical Center - Ichilov Hospital

Tel Aviv Sourasky Medical Center - Ichilov Hospital

Other: No intervention

Galil Medical Center

Galil Medical Center

Other: No intervention

Ziv Medical Center

Ziv Medical Center

Other: No intervention

Emek Medical Center

Emek Medical Center

Other: No intervention

Beilinson Hospital

Beilinson Hospital

Other: No intervention

Meir Medical Center

Meir Medical Center

Other: No intervention

Kaplan Medical Center

Kaplan Medical Center

Other: No intervention

Sheba Medical Center

Sheba Medical Center

Other: No intervention

Rambam Medical Center

Rambam Medical Center

Other: No intervention

Shaare Zdek Medical Center

Shaare Zdek Medical Center

Other: No intervention

Hadassah Medical Center

Hadassah Medical Center

Other: No intervention

Shamir Medical Center (Assaf Harofeh)

Shamir Medical Center (Assaf Harofeh)

Other: No intervention

Soroka Medical Center

Soroka Medical Center

Other: No intervention

Assuta Ashdod Hospital

Assuta Ashdod Hospital

Other: No intervention

Interventions

No intervention

Assuta Ashdod HospitalBeilinson HospitalBnai Zion Medical CenterEmek Medical CenterGalil Medical CenterHadassah Medical CenterKaplan Medical CenterMeir Medical CenterRambam Medical CenterShaare Zdek Medical CenterShamir Medical Center (Assaf Harofeh)Sheba Medical CenterSoroka Medical CenterTel Aviv Sourasky Medical Center - Ichilov HospitalZiv Medical Center

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Jewish and Arab LPD families with at least 2 family members with LPD.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood and saliva samples

MeSH Terms

Conditions

Lymphoproliferative DisordersPrecancerous ConditionsLeukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasmsLeukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Geffen Kleinstern, PhD

    University of Haifa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Geffen Kleinstern, PhD

CONTACT

Tamar Tadmor, MD

CONTACT

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
OTHER
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 8, 2023

Study Start

June 1, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2040

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share