Systemic Inflammatory Markers in B-cell Neoplasm

Not yet recruiting

• Conditions: B-cell Neoplasm

• Registration Number: NCT06847529
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-02-21
• Study First Posted: 2025-02-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-09
• Last Update Posted: 2025-03-12
• Study Start: 2025-03-22
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of Optimal Cut-off Values for Systemic Inflammatory Indices in B-cell Neoplasms Using Laboratory Blood Tests	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 Outcome Measures

Name	Time	Method
Prognostic Value of Baseline Systemic Inflammatory Markers on Overall Survival in B-cell Neoplasm Patients	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.

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt