Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma

Официальное название

Cognitive Impairment in Patients With Diffuse Large B-cell Lymphoma

Обзор

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.

Подробное описание

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.

The primary objective is to evaluate longitudinal changes in cognitive performance and to identify clinical and biological predictors of treatment-associated cognitive impairment.

Вмешательства

• Диагностический тест Structured Neurocognitive Assessment Battery
  Standardized neurocognitive testing including Montreal Cognitive Assessment (MoCA), Short Cognitive Performance Test (KPSS), and selected CANTAB computerized tasks assessing attention, working memory, executive function, processing speed, and episodic memory. Assessments are performed at baseline (prior to treatment initiation), after the first chemotherapy cycle, and 12 months after treatment initiation.
• Диагностический тест Psychometric Questionnaires
  Validated questionnaires assessing anxiety, depression, fatigue, cognitive complaints, and quality of life (HADS, HAM-D, FSS, FACT-Cog v3, EORTC QLQ-C30, ECOG Performance Status). Questionnaires are administered at predefined study time points.
• Диагностический тест CSF Biomarker Analysis
  Quantification of cerebrospinal fluid biomarkers (phosphorylated tau, total tau, amyloid beta 40, amyloid beta 42, neurofilament light chain, GFAP). CSF samples are collected during clinically indicated lumbar punctures prior to intrathecal chemotherapy administration. No additional lumbar punctures are performed solely for research purposes.

Первичные конечные точки

• Cognitive Function (MoCA Total Score) [Срок оценки: Baseline (within 7 days prior to treatment initiation)]
• Change in Cognitive Function (MoCA Total Score) [Срок оценки: After first chemotherapy cycle (Cycle 1 Day 14-21)]
• Change in Cognitive Function (MoCA Total Score) [Срок оценки: 12 months after treatment initiation (±4 weeks).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Словения · 1 центр

• Institute of Oncology Ljubljana — Ljubljana

Идентификаторы

NCT: NCT07443514 · OI-DVBL-CI-2022-675 · KME-2022-675

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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