Chronic Lymphoproliferative DiseaseNCT06893640
Cell Population Data in CLPD and Viral Disease
An observational study of Chronic Lymphoproliferative Disease, run by Assiut University.
Trial summary
Hematological malignancies typically arise from two major blood cell lineages: lymphoid and myeloid cells . Hematological malignancies are the fourth most frequently diagnosed cancer around the world . Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Lymphoproliferative Disease
- How many people
- 177 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Jun 2026
- 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Lymphoproliferative Disease: 59 patients * Viral hepatitis infection: 59 patients * Healthy control : 59
Who may be able to join
- 1-Age > 18 years old 2- Patient newly diagnosed CLPD according to the recent WHO classification; based on bone marrow examination, immunophenotyping \&/or LN biopsy 3- Patients are newly diagnosed with viral hepatitis infection based on viral serology
Who cannot join
- 1- patient on treatment 2- Patient has both chronic lymphoproliferative disorders and viral hepatitis infection 3- Patient has any other' hematological disease 4- Patient has any chronic disease affect hematological parameters. 5- patient with incomplete medical records
About this study
Official title: Comparative Analysis of Cell Population Data in Chronic Lymphproliferative Disorder and Viral Disease
Hematological malignancies typically arise from two major blood cell lineages: lymphoid and myeloid cells . Hematological malignancies are the fourth most frequently diagnosed cancer around the world .
Chronic lymphoproliferative disorders (CLPD) comprise a heterogeneous group of diseases characterized by uncontrolled production of lymphocytes that cause monoclonal lymphocytosis, lymphadenopathy and bone marrow infiltration. These diseases often occur in immuno-compromised individuals. There are two subsets of lymphocytes: T and B cells that regenerate uncontrollably to produce immunoproliferative disorders, which are prone to immunodeficiency, a dysfunctional immune system, and lymphocyte dysregulation. Several gene mutations have been described as causes of CLPD that can be iatrogenic or acquired .
Read more
Viral infections induce lymphocyte activation, undifferentiated lymphocyte proliferation, and antibody or cytokine/lymphokine secretion. The immune defense against viral infection is more dependent on T cells and less dependent on antibodies. Cytotoxic T cells are important in killing virally infected cells. A number of cytokines, including interferon gamma and tumor necrosis factor (TNF), are secreted by the cytotoxic T cells.1It is conceivable that the activated lymphocytes may undergo not only morphologic changes, such as an increase in size, but also alterations in cytoplasmic composition as compared to their normal 'resting' counterparts .
Beyond the differential leukocyte count, modern hematological analyzers provide additional quantitative data known as "cell population data (CPD) which is regarded as the fingerprint of a blood cell at a given moment. CPD parameters harbor information associated with cell morphology and offer detailed information about the size, complexity, and fluorescence characteristics of different cell populations, potentially aiding in the diagnosis and management of various haematological conditions .
There has been no comprehensive study on the usefulness of cell population data (CPD) parameters as a screening tool in the discrimination of non-neoplastic(viral infection) and neoplastic haematological disorders such CLPD.
the aim of the study evalute clinical utility of CPD parameters generated by haematological analyser in diagnosis of both CLPD \&viral infection 2-to compare performance of CPD parameters with other established diagnostic \&prognostic markers in CLPD
- Conditions
- Chronic Lymphoproliferative Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Lymphoproliferative Disease | |
| Group 2 | Viral hepatitis infection | |
| Group 3 | Healthy control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukocyte cell population data
Leukocyte cell population data (CPD)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphoproliferative DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa habeeb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893640
- Sponsor's protocol ID
- Cpd in CLPD and viral disease
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Cell Population Data in Chronic Lymphproliferative Disorder and Viral Disease
- ClinicalTrials.gov ID
- NCT06893640
- Acronym / sponsor ID
- Cpd in CLPD and viral disease
- Conditions
- Chronic Lymphoproliferative Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 25 Mar 2025 (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.
Hematological malignancies typically arise from two major blood cell lineages: lymphoid and myeloid cells . Hematological malignancies are the fourth most frequently diagnosed cancer around the world .
Chronic lymphoproliferative disorders (CLPD) comprise a heterogeneous group of diseases characterized by uncontrolled production of lymphocytes that cause monoclonal lymphocytosis, lymphadenopathy and bone marrow infiltration. These diseases often occur in immuno-compromised individuals. There are two subsets of lymphocytes: T and B cells that regenerate uncontrollably to produce immunoproliferative disorders, which are prone to immunodeficiency, a dysfunctional immune system, and lymphocyte dysregulation. Several gene mutations have been described as causes of CLPD that can be iatrogenic or acquired .
Viral infections induce lymphocyte activation, undifferentiated lymphocyte proliferation, and antibody or cytokine/lymphokine secretion. The immune defense against viral infection is more dependent on T cells and less dependent on antibodies. Cytotoxic T cells are important in killing virally infected cells. A number of cytokines, including interferon gamma and tumor necrosis factor (TNF), are secreted by the cytotoxic T cells.1It is conceivable that the activated lymphocytes may undergo not only morphologic changes, such as an increase in size, but also alterations in cytoplasmic composition as compared to their normal 'resting' counterparts .
Beyond the differential leukocyte count, modern hematological analyzers provide additional quantitative data known as "cell population data (CPD) which is regarded as the fingerprint of a blood cell at a given moment. CPD parameters harbor information associated with cell morphology and offer detailed information about the size, complexity, and fluorescence characteristics of different cell populations, potentially aiding in the diagnosis and management of various haematological conditions .
There has been no comprehensive study on the usefulness of cell population data (CPD) parameters as a screening tool in the discrimination of non-neoplastic(viral infection) and neoplastic haematological disorders such CLPD.
the aim of the study evalute clinical utility of CPD parameters generated by haematological analyser in diagnosis of both CLPD \&viral infection 2-to compare performance of CPD parameters with other established diagnostic \&prognostic markers in CLPD
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Lymphoproliferative Disease |
| Group 2 | – | –Viral hepatitis infection |
| Group 3 | – | –Healthy control |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Lymphoproliferative Disease: 59 patients * Viral hepatitis infection: 59 patients * Healthy control : 59
Key inclusion criteria (1 listed)
- 1-Age > 18 years old 2- Patient newly diagnosed CLPD according to the recent WHO classification; based on bone marrow examination, immunophenotyping \&/or LN biopsy 3- Patients are newly diagnosed with viral hepatitis infection based on viral serology
Key exclusion criteria (1 listed)
- 1- patient on treatment 2- Patient has both chronic lymphoproliferative disorders and viral hepatitis infection 3- Patient has any other' hematological disease 4- Patient has any chronic disease affect hematological parameters. 5- patient with incomplete medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Leukocyte cell population data
Time frame: baseline
Leukocyte cell population data (CPD)
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 25 Mar 2025.
Related trials for Chronic Lymphoproliferative Disease
RecruitingObservational study
Genetic Studies of Chronic Active Epstein-Barr Disease
Chronic Active Epstein-Barr Virus
Active, not recruitingObservational study
Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer
Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
RecruitingObservational study
Establishing a Tumor Bank in Families With Multiple Lymphoproliferative Malignancies
Non-Hodgkin's Lymphoma, Hodgkin's Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphoproliferative Disease, run by Assiut University.
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 1 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 25 Mar 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leukocyte cell population data (time frame: baseline). 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 25 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.