- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05718986
Familial B-cell Lymphoproliferative Disorders (Familial_LPD)
May 7, 2024 updated by: Geffen Kleinstern, University of Haifa
Epidemiology of Familial B-cell Lymphoproliferative Disorders
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Geffen Kleinstern, PhD
- Phone Number: +972545715624
- Email: gkleinste@univ.haifa.ac.il
Study Contact Backup
- Name: Tamar Tadmor, MD
- Email: tamar.tadmor@b-zion.org.il
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Jewish and Arab LPD families with at least 2 family members with LPD.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Bnai Zion Medical Center
|
No intervention
|
Tel Aviv Sourasky Medical Center - Ichilov Hospital
|
No intervention
|
Galil Medical Center
|
No intervention
|
Ziv Medical Center
|
No intervention
|
Emek Medical Center
|
No intervention
|
Beilinson Hospital
|
No intervention
|
Meir Medical Center
|
No intervention
|
Kaplan Medical Center
|
No intervention
|
Sheba Medical Center
|
No intervention
|
Rambam Medical Center
|
No intervention
|
Shaare Zdek Medical Center
|
No intervention
|
Hadassah Medical Center
|
No intervention
|
Shamir Medical Center (Assaf Harofeh)
|
No intervention
|
Soroka Medical Center
|
No intervention
|
Assuta Ashdod Hospital
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of familial LPD in Israel
Time Frame: 5 years
|
5 years
|
Association between medical history and genetic variants and the risk of familial LPD
Time Frame: 5 years
|
5 years
|
Risk of clinical outcomes among familial LPD and family members
Time Frame: 15 years
|
15 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Geffen Kleinstern, PhD, University of Haifa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2024
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2040
Study Registration Dates
First Submitted
January 30, 2023
First Submitted That Met QC Criteria
January 30, 2023
First Posted (Actual)
February 8, 2023
Study Record Updates
Last Update Posted (Actual)
May 8, 2024
Last Update Submitted That Met QC Criteria
May 7, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Hematologic Diseases
- Leukocyte Disorders
- Leukemia
- Leukemia, B-Cell
- Chronic Disease
- Leukocytosis
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Lymphoproliferative Disorders
- Precancerous Conditions
- Lymphocytosis
Other Study ID Numbers
- FamilialLPD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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