Actively Recruiting
Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma
Led by Institute of Oncology Ljubljana · Updated on 2026-03-02
3
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Newly diagnosed diffuse large B-cell lymphoma planned for systemic chemotherapy (R-CHOP) with or without intrathecal chemotherapy
- Ability to provide written informed consent
- For healthy controls: relatives of patients willing to undergo cognitive testing and questionnaires
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
N
Nadja Novak Bošnjak
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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