Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma

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.

Eligibility

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

Conditions2

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