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Recruiting NCT07057765

Predictive Value of CRP, Albumin, CAR, and mGPS in Treatment Outcomes of DLBCL

— Observational DLBCL - Diffuse Large B Cell Lymphoma Markers of Inflammation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational Assessment of Standard R-CHOP Treatment.
Who it may be relevant to
Registry conditions: DLBCL - Diffuse Large B Cell Lymphoma, Markers of Inflammation. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Predictive Value of CRP, Albumin, CAR, and mGPS in DLBCL: A Prospective Cohort Study on Treatment Outcomes and Toxicity

Overview

This observational study evaluates the predictive value of systemic inflammatory markers-CRP, albumin, CRP-to-albumin ratio (CAR), and modified Glasgow Prognostic Score (mGPS)-in patients with diffuse large B-cell lymphoma (DLBCL) receiving R-CHOP chemotherapy. The study examines associations with treatment response, toxicity, and clinical characteristics.

Detailed description

This prospective cohort study investigates the predictive significance of systemic inflammatory markers-CRP, serum albumin, CRP-to-albumin ratio (CAR), and modified Glasgow Prognostic Score (mGPS)-in patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP chemotherapy. The study aims to assess correlations between these markers and treatment outcomes, including objective response rate (ORR) and treatment-related toxicity. Inflammatory markers will be measured at baseline and after three chemotherapy cycles. Treatment response will be evaluated using Lugano classification criteria, and toxicity will be assessed per CTCAE version 5.0. The study also explores associations with clinical characteristics such as disease stage and performance status, aiming to enhance prognostic modeling and support personalized treatment strategies in DLBCL.

Interventions

  • Drug Observational Assessment of Standard R-CHOP Treatment
    Patients will receive R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) as part of routine clinical care. The study does not assign or modify treatment. Data will be collected to assess the association between inflammatory markers and clinical outcomes.

Primary outcome measures

  • Objective Response Rate (ORR) Following 3 Cycles of R-CHOP Based on Baseline Inflammatory Markers [Time frame: Baseline (Day 1 of Cycle 1) and Day 63 (End of Cycle 3; each cycle is 21 days)]
  • Incidence of Treatment-Related Toxicity During Initial Treatment According to Baseline Inflammatory Markers [Time frame: Day 1 of Cycle 1 through Day 63 (End of Cycle 3; each cycle is 21 days)]
Secondary outcome measures (1)
  • Proportion of Patients in Each IPI Risk Category by Baseline Inflammatory Marker Levels [Time frame: Day 1 of Cycle 1 (each cycle is 21 days)]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years and ≤ 65 years
  • Pathologically confirmed, treatment-naïve diffuse large B-cell lymphoma (DLBCL)
  • Any stage of disease (nodal or extra-nodal), with or without B symptoms
  • Scheduled to receive standard systemic treatment (R-CHOP)
  • ECOG performance status 0-2
  • Baseline normal:
  • Complete blood count (CBC)
  • Hepatitis viral markers
  • Liver and renal function tests
  • Urine analysis
  • Echocardiogram
  • Additional investigations to exclude current infection if clinically indicated

Exclusion criteria

  • History of other concurrent or previous malignancies
  • Relapsed or refractory DLBCL
  • Uncontrolled comorbid conditions that may interfere with study participation, including:
  • Diabetes mellitus
  • Autoimmune diseases
  • Active infections
  • Chronic inflammatory diseases
  • Cardiac dysfunction
  • Liver cell failure
  • Pregnant females

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Clinical Oncology and Nuclear Medicine Department, Faculty of Medicine, Ain Shams Universi — Cairo

Identifiers

NCT: NCT07057765 · FMASU MD104/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗