Clinical trial NCT06847529: Systemic Inflammatory Markers in B-cell Neoplasm
Official title: Systemic Inflammatory Markers As a Prognostic Index for B-cell Neoplasm , Single Center Experience .
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: B-cell Neoplasm
Keywords: Systemic inflammatory markers as a prognostic index
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Determination of Optimal Cut-off Values for Systemic Inflammatory Indices in B-cell Neoplasms Using Laboratory Blood Tests
timeFrame: Baseline
Secondary outcomes:
measure: Prognostic Value of Baseline Systemic Inflammatory Markers on Overall Survival in B-cell Neoplasm Patients
timeFrame: From baseline up to 8 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Alaa El-Din Abdel Moneim El-Sayed, Doctor
role: STUDY_CHAIR
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