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NCT Number: NCT06847529

Systemic Inflammatory Markers in B-cell Neoplasm

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

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Key information

Conditions

B-Cell Neoplasm Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University

Asyut, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mai Mostafa Mohamed, Doctor

CONTACT

[email protected]

01223971678

Marlien Wiliam Fayez, Resident doctor

CONTACT

[email protected]

01156900472

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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