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

NCT07057765 | Recruiting DMC

• 1 other identifier: FMASU MD104/2025
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

DLBCL - Diffuse Large B Cell Lymphoma; Markers of Inflammation

Keywords

DLBCL; CRP To Albumin Ratio; CAR; modified Glassgow Prognostic Score; mGPS

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR) Following 3 Cycles of R-CHOP Based on Baseline Inflammatory Markers

  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.

  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

  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.

  Day 1 of Cycle 1 through Day 63 (End of Cycle 3; each cycle is 21 days)

Secondary Outcomes (1)

• Proportion of Patients in Each IPI Risk Category by Baseline Inflammatory Marker Levels

  Day 1 of Cycle 1 (each cycle is 21 days)

Study Arms (1)

Patients with DLBCL Treated with R-CHOP (Observational Group)

Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) who are receiving R-CHOP chemotherapy as part of standard clinical care. This observational study aims to evaluate the predictive value of baseline inflammatory markers (CRP, albumin, CAR, and mGPS) on treatment response and toxicity. No study-specific interventions are administered.

Drug: Observational Assessment of Standard R-CHOP Treatment

Interventions

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.

Patients with DLBCL Treated with R-CHOP (Observational Group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Treatment-naïve, pathologically confirmed DLBCL patients who will attend the Clinical Oncology and Nuclear Medicine Department until the target sample size is reached. All participants will receive standard treatment protocol (R-CHOP) after providing informed consent.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, Cairo Governorate, 1181, Egypt

RECRUITING

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Mahmoud M Ellithy, MD

  Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

• Shaimaa A Pessar, MD

  Faculty of Medicine, Ain Shams University

  STUDY DIRECTOR

• Reham M Faheim, MD

  Faculty of Medicine, Ain Shams University

  STUDY DIRECTOR

• Doaa A Mohamed, MD

  Faculty of Medicine, Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Alaa M Elsayed, MSc

CONTACT

+201112490913; alaa.abdou@med.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: July 10, 2025
• Study Start: May 5, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)