Cognitive Impairment in Patients With Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Cognitive Function (MoCA Total Score)
研究概览
简要总结
This prospective, non-randomized diagnostic interventional study evaluates cognitive impairment in patients with diffuse large B-cell lymphoma (DLBCL) treated at the Institute of Oncology Ljubljana. Chemotherapy regimens are administered according to clinical indication and are not assigned by the study protocol.
The research intervention consists of structured neurocognitive assessments and biomarker analyses performed at predefined time points during treatment and follow-up. Cognitive function will be assessed at baseline, after the first chemotherapy cycle, and 12 months after treatment initiation. In patients receiving intrathecal chemotherapy, cerebrospinal fluid (CSF) biomarkers will be analyzed using samples collected during clinically indicated lumbar punctures.
The study aims to characterize the frequency, severity, and trajectory of cognitive impairment and to identify clinical and biological predictors of treatment-associated cognitive changes in patients with DLBCL.
详细描述
This is a prospective, non-randomized interventional diagnostic study conducted at the Institute of Oncology Ljubljana. The study does not assign or modify therapeutic regimens; chemotherapy is administered exclusively according to clinical indication.
The research intervention consists of a structured neurocognitive assessment protocol and biomarker analyses performed at predefined time points during treatment and follow-up.
Adult patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) will be enrolled into parallel groups based on clinically indicated treatment (systemic chemotherapy alone or systemic plus intrathecal chemotherapy). A comparison group of healthy relatives will also be included.
Cognitive function will be assessed at baseline (prior to treatment initiation), after the first chemotherapy cycle, and 12 months after treatment initiation. In patients receiving intrathecal chemotherapy, an additional cognitive assessment will be performed before the last intrathecal cycle.
Cerebrospinal fluid (CSF) biomarkers (phosphorylated tau, total tau, amyloid beta 40, amyloid beta 42, neurofilament light chain, GFAP) will be quantified in patients receiving intrathecal chemotherapy. CSF samples will be collected during clinically indicated lumbar punctures performed for therapeutic purposes. No additional lumbar punctures will be performed solely for research purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 80 years
- •Newly diagnosed diffuse large B-cell lymphoma (DLBCL) planned for treatment with systemic chemotherapy (R-CHOP) with or without intrathecal chemotherapy
- •Ability to provide written informed consent
- •For healthy volunteer/control group: relatives of participating patients willing to undergo cognitive testing and questionnaires
排除标准
- •Severe cognitive impairment preventing completion of neurocognitive testing
- •Severe psychiatric disorder or neurological disease interfering with cognitive assessment
- •Inability to understand study procedures or complete questionnaires
- •Refusal or inability to provide informed consent
研究组 & 干预措施
DLBCL - Systemic Chemotherapy (R-CHOP)
Adult patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) receiving standard systemic chemoimmunotherapy (R-CHOP) according to clinical indication. The study does not assign treatment. The research intervention consists of structured neurocognitive assessments and psychometric evaluations performed at predefined time points during treatment and follow-up.
干预措施: Structured Neurocognitive Assessment Battery (Diagnostic Test)
DLBCL - Systemic Chemotherapy (R-CHOP)
Adult patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) receiving standard systemic chemoimmunotherapy (R-CHOP) according to clinical indication. The study does not assign treatment. The research intervention consists of structured neurocognitive assessments and psychometric evaluations performed at predefined time points during treatment and follow-up.
干预措施: Psychometric Questionnaires (Diagnostic Test)
DLBCL - Systemic + Intrathecal Chemotherapy
Adult patients with newly diagnosed DLBCL receiving systemic chemoimmunotherapy (R-CHOP) and additional intrathecal chemotherapy (methotrexate and cytarabine) according to clinical indication. The study does not determine treatment allocation. The research intervention consists of structured neurocognitive assessments and cerebrospinal fluid (CSF) biomarker analyses performed at predefined time points.
干预措施: Structured Neurocognitive Assessment Battery (Diagnostic Test)
DLBCL - Systemic + Intrathecal Chemotherapy
Adult patients with newly diagnosed DLBCL receiving systemic chemoimmunotherapy (R-CHOP) and additional intrathecal chemotherapy (methotrexate and cytarabine) according to clinical indication. The study does not determine treatment allocation. The research intervention consists of structured neurocognitive assessments and cerebrospinal fluid (CSF) biomarker analyses performed at predefined time points.
干预措施: Psychometric Questionnaires (Diagnostic Test)
DLBCL - Systemic + Intrathecal Chemotherapy
Adult patients with newly diagnosed DLBCL receiving systemic chemoimmunotherapy (R-CHOP) and additional intrathecal chemotherapy (methotrexate and cytarabine) according to clinical indication. The study does not determine treatment allocation. The research intervention consists of structured neurocognitive assessments and cerebrospinal fluid (CSF) biomarker analyses performed at predefined time points.
干预措施: CSF Biomarker Analysis (Diagnostic Test)
Healthy Control Group (Relatives)
Adult relatives of participating patients without DLBCL serving as a comparison group. Participants undergo structured neurocognitive testing and psychometric evaluation only. No invasive procedures are performed.
干预措施: Structured Neurocognitive Assessment Battery (Diagnostic Test)
Healthy Control Group (Relatives)
Adult relatives of participating patients without DLBCL serving as a comparison group. Participants undergo structured neurocognitive testing and psychometric evaluation only. No invasive procedures are performed.
干预措施: Psychometric Questionnaires (Diagnostic Test)
结局指标
主要结局
Cognitive Function (MoCA Total Score)
时间窗: Baseline (within 7 days prior to treatment initiation)
Change in MoCA total score from baseline across follow-up assessments.
Change in Cognitive Function (MoCA Total Score)
时间窗: After first chemotherapy cycle (Cycle 1 Day 14-21)
Change in MoCA total score from baseline across follow-up assessments.
Change in Cognitive Function (MoCA Total Score)
时间窗: 12 months after treatment initiation (±4 weeks).
Change in MoCA total score from baseline across follow-up assessments.
次要结局
未报告次要终点