An interventional study of Structured Neurocognitive Assessment Battery and Psychometric Questionnaires in Diffuse Large B-Cell Lymphoma, sponsored by Institute of Oncology Ljubljana. Recruiting at 1 site in Slovenia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Institute of Oncology Ljubljana · Not applicable, Interventional, and Diagnostic
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.
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.
1,868 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 355 are open to participants now.
This study's planned enrollment of 3 is below the median of 45 across 1,497 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Institute of Oncology Ljubljana is the lead sponsor of 81 studies on the registry; 26 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Structured Neurocognitive Assessment Battery · Diagnostic Test: Psychometric Questionnaires
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.
Diagnostic Test: Structured Neurocognitive Assessment Battery · Diagnostic Test: Psychometric Questionnaires · Diagnostic Test: CSF Biomarker Analysis
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.
Diagnostic Test: Structured Neurocognitive Assessment Battery · Diagnostic Test: Psychometric Questionnaires
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.
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.
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.
Cognitive Function (MoCA Total Score)
Change in MoCA total score from baseline across follow-up assessments.
Time frame: Baseline (within 7 days prior to treatment initiation)
Change in Cognitive Function (MoCA Total Score)
Change in MoCA total score from baseline across follow-up assessments.
Time frame: After first chemotherapy cycle (Cycle 1 Day 14-21)
Change in Cognitive Function (MoCA Total Score)
Change in MoCA total score from baseline across follow-up assessments.
Time frame: 12 months after treatment initiation (±4 weeks).
Started Jan 2022 (actual). Primary completion is estimated for Dec 2026, 59 months after the start.
Of 40 non-industry interventional studies with no phase under Lymphoma, Large B-Cell, Diffuse, half reached primary completion within 73 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 144. This study's planned 59 months is below that.
Counting every sponsor, half of 41 studies reached it within 73 months; a quarter within 42 and three quarters within 137.
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Lymphoma, Large B-Cell, Diffuse →
Institute of Oncology Ljubljana