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Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma

NCT07443514 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

  • Diffuse Large B-Cell Lymphoma

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Institute of Oncology Ljubljana

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07443514 on ClinicalTrials.gov