RecruitingNot ApplicableNCT07443514

Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma

Cognitive Impairment in Patients With Diffuse Large B-cell Lymphoma

Sponsor

Institute of Oncology Ljubljana

Enrollment

3 participants

Start Date

Jan 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether cognitive problems (difficulties with memory, attention, and thinking) occur in people newly diagnosed with diffuse large B-cell lymphoma (DLBCL) — an aggressive type of blood cancer — and if so, how these change over time with chemotherapy treatment. Healthy relatives of patients may also participate as a comparison group. **You may be eligible if...** - You are between 18 and 80 years old - You have been newly diagnosed with diffuse large B-cell lymphoma - You are planned to receive R-CHOP chemotherapy (with or without treatment injected into the spinal fluid) - You are able to provide written consent - You are a healthy relative of a participating patient willing to do cognitive tests (control group) **You may NOT be eligible if...** - You have severe cognitive impairment that would prevent you from completing thinking and memory tests - You have a severe psychiatric or neurological condition that would interfere with cognitive testing - You are unable to understand the study procedures or provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(1)

Institute of Oncology Ljubljana

Ljubljana, Slovenia

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NCT07443514

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