Diffuse Large B-Cell Lymphoma
Conditions
Keywords
Diffuse large B-cell lymphoma, Chemotherapy-related cognitive impairment
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTStructured 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.
DIAGNOSTIC_TESTPsychometric 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.
DIAGNOSTIC_TESTCSF 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.
Sponsors
Institute of Oncology Ljubljana
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Parallel assignment, non-randomized, diagnostic interventional study with three groups defined by clinically indicated treatment exposure (systemic chemotherapy, systemic plus intrathecal chemotherapy, and healthy controls).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function (MoCA Total Score) | 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) | After first chemotherapy cycle (Cycle 1 Day 14-21) | Change in MoCA total score from baseline across follow-up assessments. |
Countries
Slovenia
Contacts
CONTACTNadja Novak Bošnjak
Outcome results
None listed