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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alaa M Elsayed, MSc | Contact | +201112490913 | alaa.abdou@med.asu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mahmoud M Ellithy, MD | Faculty of Medicine, Ain Shams University | Principal Investigator |
| Shaimaa A Pessar, MD | Faculty of Medicine, Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Oncology and Nuclear Medicine Department, Faculty of Medicine, Ain Shams University | Recruiting | Cairo | Cairo Governorate | 1181 | Egypt |
Because the study is conducted within an academic setting and involves patient data that cannot be shared publicly due to confidentiality and ethical considerations."
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| ID | Term |
|---|---|
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| ID | Term |
|---|---|
| D015620 | Histiocytic Disorders, Malignant |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015614 | Histiocytosis |
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|
| Day 1 of Cycle 1 (each cycle is 21 days) |
| Reham M Faheim, MD |
| Faculty of Medicine, Ain Shams University |
| Study Director |
| Doaa A Mohamed, MD | Faculty of Medicine, Ain Shams University | Study Director |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |