Cell Population Data in CLPD and Viral Disease

March 23, 2025 updated by: Randa habeeb, Assiut University

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 .

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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

177

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  • Lymphoproliferative Disease: 59 patients
  • Viral hepatitis infection: 59 patients
  • Healthy control : 59

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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
Group 3
Healthy control
Group 1
Lymphoproliferative Disease
Group 2
Viral hepatitis infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leukocyte cell population data
Time Frame: baseline
Leukocyte cell population data (CPD)
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

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)

May 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

March 23, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 23, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cpd in CLPD and viral disease

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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