Lymphoproliferative DisordersFamilial_LPDNCT05718986
Familial B-cell Lymphoproliferative Disorders
An observational study of Lymphoproliferative Disorders and Premalignant, run by University of Haifa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphoproliferative Disorders, Premalignant, Monoclonal B-Cell Lymphocytosis
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Dec 2040
- How long will I take part?
- 15 Years
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Jewish and Arab LPD families with at least 2 family members with LPD.
Who may be able to join
- 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.
Who cannot join
- Pregnant women, special populations and those lacking judgment will not be included
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Tamar Tadmor, MD contact
About this study
Official title: 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.
- Conditions
- Lymphoproliferative Disorders, Premalignant, Monoclonal B-Cell Lymphocytosis, Chronic Lymphocytic Leukemia
- Being tested
- No intervention
- Keywords
- lymphoproliferative disorders, Chronic Lymphocytic Leukemia, Monoclonal B-cell Lymphocytosis
- Medical subject headings
- Lymphoproliferative Disorders, Precancerous Conditions, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Bnai Zion Medical Center | Bnai Zion Medical Center Receives: Other: No intervention | |
| Tel Aviv Sourasky Medical Center - Ichilov Hospital | Tel Aviv Sourasky Medical Center - Ichilov Hospital Receives: Other: No intervention | |
| Galil Medical Center | Galil Medical Center Receives: Other: No intervention | |
| Ziv Medical Center | Ziv Medical Center Receives: Other: No intervention | |
| Emek Medical Center | Emek Medical Center Receives: Other: No intervention | |
| Beilinson Hospital | Beilinson Hospital Receives: Other: No intervention | |
| Meir Medical Center | Meir Medical Center Receives: Other: No intervention | |
| Kaplan Medical Center | Kaplan Medical Center Receives: Other: No intervention | |
| Sheba Medical Center | Sheba Medical Center Receives: Other: No intervention | |
| Rambam Medical Center | Rambam Medical Center Receives: Other: No intervention | |
| Shaare Zdek Medical Center | Shaare Zdek Medical Center Receives: Other: No intervention | |
| Hadassah Medical Center | Hadassah Medical Center Receives: Other: No intervention | |
| Shamir Medical Center (Assaf Harofeh) | Shamir Medical Center (Assaf Harofeh) Receives: Other: No intervention | |
| Soroka Medical Center | Soroka Medical Center Receives: Other: No intervention | |
| Assuta Ashdod Hospital | Assuta Ashdod Hospital Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of familial LPD in Israel
Measured: 5 years
Association between medical history and genetic variants and the risk of familial LPD
Measured: 5 years
Risk of clinical outcomes among familial LPD and family members
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study startJun 2024 (estimated)
- Primary completionDec 2028 (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 Lymphoproliferative DisordersStudies 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
- Family based
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Bnai Zion Medical Center
- Responsible party
- Principal investigator, Geffen Kleinstern, University of Haifa
- Investigators
- Geffen Kleinstern, PhD, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718986
- Sponsor's protocol ID
- FamilialLPD
- Acronym
- Familial_LPD
- Status last verified
- May 2024
- First submitted
- 30 Jan 2023
- Last updated
- 8 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Familial B-cell Lymphoproliferative Disorders
- ClinicalTrials.gov ID
- NCT05718986
- Acronym / sponsor ID
- Familial_LPD / FamilialLPD
- Conditions
- Lymphoproliferative Disorders, Premalignant, Monoclonal B-Cell Lymphocytosis, Chronic Lymphocytic Leukemia
- Keywords
- lymphoproliferative disorders, Chronic Lymphocytic Leukemia, Monoclonal B-cell Lymphocytosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Bnai Zion Medical Center
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 8 Feb 2023 (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.
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 design
- Observational model
- Family based
- Time perspective
- Other
- Target follow-up
- 15 Years
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Bnai Zion Medical Center | – | Other: No interventionBnai Zion Medical Center |
| Tel Aviv Sourasky Medical Center - Ichilov Hospital | – | Other: No interventionTel Aviv Sourasky Medical Center - Ichilov Hospital |
| Galil Medical Center | – | Other: No interventionGalil Medical Center |
| Ziv Medical Center | – | Other: No interventionZiv Medical Center |
| Emek Medical Center | – | Other: No interventionEmek Medical Center |
| Beilinson Hospital | – | Other: No interventionBeilinson Hospital |
| Meir Medical Center | – | Other: No interventionMeir Medical Center |
| Kaplan Medical Center | – | Other: No interventionKaplan Medical Center |
| Sheba Medical Center | – | Other: No interventionSheba Medical Center |
| Rambam Medical Center | – | Other: No interventionRambam Medical Center |
| Shaare Zdek Medical Center | – | Other: No interventionShaare Zdek Medical Center |
| Hadassah Medical Center | – | Other: No interventionHadassah Medical Center |
| Shamir Medical Center (Assaf Harofeh) | – | Other: No interventionShamir Medical Center (Assaf Harofeh) |
| Soroka Medical Center | – | Other: No interventionSoroka Medical Center |
| Assuta Ashdod Hospital | – | Other: No interventionAssuta Ashdod Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Jewish and Arab LPD families with at least 2 family members with LPD.
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- Pregnant women, special populations and those lacking judgment will not be included
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Assuta Ashdod Hospital, Beilinson Hospital, Bnai Zion Medical Center, Emek Medical Center, Galil Medical Center, Hadassah Medical Center, Kaplan Medical Center, Meir Medical Center, Rambam Medical Center, Shaare Zdek Medical Center, Shamir Medical Center (Assaf Harofeh), Sheba Medical Center, Soroka Medical Center, Tel Aviv Sourasky Medical Center - Ichilov Hospital, Ziv Medical Center |
Primary outcome
Prevalence of familial LPD in Israel
Time frame: 5 years
Association between medical history and genetic variants and the risk of familial LPD
Time frame: 5 years
Risk of clinical outcomes among familial LPD and family members
Time frame: 15 years
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 8 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.
Tamar Tadmor, MD contact
Geffen Kleinstern, PhD principal investigator
University of Haifa
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoproliferative Disorders and Premalignant, 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 5 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 8 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, PhD (+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?
Prevalence of familial LPD in Israel (time frame: 5 years). The study lists 3 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 8 May 2024.