Predictive Value of CRP, Albumin, CAR, and mGPS in DLBCL: A Prospective Cohort Study on Treatment Outcomes and Toxicity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) Following 3 Cycles of R-CHOP Based on Baseline Inflammatory Markers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Observational Assessment of Standard R-CHOP Treatment (Drug)
结局指标
主要结局
Objective Response Rate (ORR) Following 3 Cycles of R-CHOP Based on Baseline Inflammatory Markers
时间窗: 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.
Incidence of Treatment-Related Toxicity During Initial Treatment According to Baseline Inflammatory Markers
时间窗: 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.
次要结局
- Proportion of Patients in Each IPI Risk Category by Baseline Inflammatory Marker Levels(Day 1 of Cycle 1 (each cycle is 21 days))