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NCT Number: NCT07057765

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

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.

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Key information

Conditions

DLBCL - Diffuse Large B Cell Lymphoma Dendritic Cell Sarcoma, Interdigitating Hemic and Lymphatic Diseases Histiocytic Disorders, Malignant Histiocytosis Lymphatic Diseases Markers of Inflammation Neoplasms Neoplasms by Histologic Type

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Oncology and Nuclear Medicine Department, Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, 1181, Egypt

Location status: Recruiting

Location contact

Alaa M Elsayed, MSc

CONTACT

[email protected]

+20 111 249 0913

Alaa M Elsayed, MSc

SUB_INVESTIGATOR

Doaa A Mohamed, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Observational Assessment of Standard R-CHOP Treatment

Drug

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 outcomes

  1. 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)

    Proportion ( %) of patients achieving an objective response (complete or partial) according to the Lugano classification after three cycles of R-CHOP chemotherapy. Patients will be stratified by baseline inflammatory markers:

    • C-reactive protein (CRP, mg/L, measured by immunoturbidimetric assay)
    • Serum albumin (g/dL, measured by colorimetric assay)
    • CRP/Albumin ratio (CAR, calculated as CRP divided by albumin)
    • Modified Glasgow Prognostic Score (mGPS, range 0-2) Response will be assessed using PET/CT imaging.

  2. 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)

    Incidence (%) of patients experiencing any-grade treatment-related adverse events during the first three cycles of R-CHOP, stratified by baseline CRP, albumin, CAR, and mGPS. Toxicity will be graded according to CTCAE version 5.0.

Secondary outcomes

  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)

    Proportion (%) of patients in each International Prognostic Index (IPI) risk category (low, intermediate, high), stratified by baseline inflammatory markers:

    • CRP (mg/L, measured by immunoturbidimetric assay)
    • Albumin (g/dL, measured by colorimetric assay)
    • CRP/Albumin ratio (CAR, calculated as CRP divided by albumin)
    • Modified Glasgow Prognostic Score (mGPS, range 0-2) IPI will be calculated based on age, LDH level, Ann Arbor stage, ECOG performance status, and extranodal involvement.

Study contacts

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

Alaa M Elsayed, MSc

CONTACT

[email protected]

+201112490913

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2025
Registry last updated
Jul 10, 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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