Systemic Inflammatory Markers in B-cell Neoplasm

March 9, 2025 updated by: Marline Wiliam Fayez Abdel-Shahid, Assiut University

Systemic Inflammatory Markers As a Prognostic Index for B-cell Neoplasm , Single Center Experience .

This study was to evaluate the role of systemic inflammatory markers in predicting outcome for patients with B cell neoplasm

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

In malignant tumors, Inflammation plays a crucial role in the development, invasion, and metastasis of malignant tumors. Cancer is often described as a wound that does not heal, highlighting the significance of inflammation in cancer progression. Many tumors are heavily infiltrated by immune cells, including macrophages, neutrophils, and lymphocytes. Therefore, markers related to inflammation and the host immune response are pertinent as biological indicators of B-cell neoplasm progression. Inflammation contributes significantly to the initiation and advancement of B-cell neoplasms by providing nutrients to tumor cells, promoting cell growth, and disrupting immune homeostasis. Various composite indices based on circulating inflammatory cells have been developed as straightforward measures to assess systemic inflammation. Elevated serum inflammatory markers reflect the body's response to malignant tumors. Pro-inflammatory cytokines and inflammatory cells within the tumor microenvironment have been shown to promote tumor growth, induce DNA damage, facilitate angiogenesis, suppress the immune system, and correlate with poor patient survival outcomes. Targeting cytokine receptors or other components in inflammatory pathways involved in metastasis may offer therapeutic potential for malignant tumors. Given the pivotal role of inflammation in cancer biology, identifying novel immune markers is essential for predicting the prognosis of patients with Diffuse Large B-Cell Lymphoma (DLBCL). patients

Study Type

Observational

Enrollment (Estimated)

70

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

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

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

No

Sampling Method

Non-Probability Sample

Study Population

Based on determining the main outcome variable, the estimated minimum required sample size is 74. The sample size was calculated using G*power software 3.1.9.4 , based on the following assumptions: Main outcome variable is the evaluation of role of systemic inflammatory markers in predicting outcome for patients with B cell neoplasm. Based on expert opinion we hypothesized to find medium effect size 0.3

Description

Inclusion Criteria:

  • Individuals newly diagnosed with B-cell neoplasms, including:
  • Burkitt's lymphoma (BL)
  • Chronic lymphocytic leukemia (CLL)
  • Diffuse large B-cell lymphoma (DLBCL)
  • Follicular lymphoma (FL)
  • Hairy cell leukemia (HCL)
  • Splenic B-cell lymphoma/leukemia with prominent nucleoli (SBLPN)
  • High-grade B-cell lymphoma (HGBL)
  • Lymphoplasmacytic lymphoma (LPL)/Waldenström macroglobulinemia
  • Mantle cell lymphoma (MCL)
  • Splenic marginal zone lymphoma (MZL)
  • Monoclonal B-cell lymphocytosis (MBL)
  • Multiple myeloma (plasma cell myeloma)
  • Monoclonal gammopathy of undetermined significance (MGUS)
  • Age 18 years or older.

Exclusion Criteria:

  • Individuals previously diagnosed with B-cell neoplasms.
  • Individuals younger than 18 years.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of Optimal Cut-off Values for Systemic Inflammatory Indices in B-cell Neoplasms Using Laboratory Blood Tests
Time Frame: Baseline
This outcome measure aims to establish the optimal cut-off values for systemic inflammatory indices-including Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), and Lymphocyte-to-Monocyte Ratio (LMR)-using routine laboratory blood tests. The blood tests will include serum lactate dehydrogenase (LDH), globulin, albumin, C-reactive protein (CRP), platelet count, neutrophil count, lymphocyte count, and monocyte count. Receiver Operating Characteristic (ROC) curve analysis will be employed to determine the optimal cut-off values for each inflammatory marker.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic Value of Baseline Systemic Inflammatory Markers on Overall Survival in B-cell Neoplasm Patients
Time Frame: From baseline up to 8 months
This outcome measure evaluates the association between baseline systemic inflammatory markers and overall survival in patients with B-cell neoplasms. The markers to be assessed include serum levels of LDH, globulin, albumin, CRP, and blood cell counts (neutrophils, lymphocytes, monocytes). Additionally, calculated indices such as NLR, PLR, LMR, CRP-to-Albumin Ratio (CAR), Albumin-to-Globulin Ratio (AGR), Systemic Immune-Inflammation Index (SII), and Systemic Inflammation Response Index (SIRI) will be determined. Patient follow-up will be conducted for 6 to 8 months or until the completion of the chemotherapeutic regimen or death.
From baseline up to 8 months

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Alaa El-Din Abdel Moneim El-Sayed, Doctor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 22, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 21, 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 9, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • markers In B-cell tumors

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

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.

Clinical Trials on B-cell Neoplasm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe