Predictive Value of CRP, Albumin, CAR, and mGPS in Treatment Outcomes of DLBCL
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorAin Shams University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
History of other concurrent or previous malignancies
Relapsed or refractory DLBCL
Diabetes mellitus
Autoimmune diseases
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational Assessment of Standard R-CHOP Treatment
DrugPatients 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Patients with DLBCL Treated with R-CHOP (Observational Group)1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Day 1 of Cycle 1) and Day 63 (End of Cycle 3; each cycle is 21 days)2
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.
Time frame
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
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.
Time frame
Day 1 of Cycle 1 (each cycle is 21 days)Sponsors and contacts
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Source ClinicalTrials.gov