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

NCT ID: NCT07057765

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2026-08-31

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.

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.

Conditions

DLBCL - Diffuse Large B Cell Lymphoma; Markers of Inflammation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Observational Assessment of Standard R-CHOP Treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahmoud M Ellithy, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Ain Shams University

Shaimaa A Pessar, MD

Role: STUDY_DIRECTOR

Faculty of Medicine, Ain Shams University

Reham M Faheim, MD

Role: STUDY_DIRECTOR

Faculty of Medicine, Ain Shams University

Doaa A Mohamed, MD

Role: STUDY_DIRECTOR

Faculty of Medicine, Ain Shams University

Locations

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

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Alaa M Elsayed, MSc

Role: CONTACT

alaa.abdou@med.asu.edu.eg

+201112490913

Facility Contacts

Alaa M Elsayed, MSc

Role: primary

alaa.abdou@med.asu.edu.eg

+20 111 249 0913

Doaa A Mohamed, MD

Role: backup

Doaa.atef@med.asu.edu.eg

Other Identifiers

FMASU MD104/2025

Identifier Type: -

Identifier Source: org_study_id