Systemic Inflammatory Markers in B-cell Neoplasm

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Burkitt's lymphoma (BL)

Chronic lymphocytic leukemia (CLL)

Diffuse large B-cell lymphoma (DLBCL)

Follicular lymphoma (FL)

Disqualifiers

Individuals previously diagnosed with B-cell neoplasms.

Individuals younger than 18 years.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Determination of Optimal Cut-off Values for Systemic Inflammatory Indices in B-cell Neoplasms Using Laboratory Blood Tests

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.

Time frame
Baseline

Secondary outcomes

1

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

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.

Time frame
From baseline up to 8 months

Other outcomes

Sponsors and contacts

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