Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma
ConditionDiffuse Large B-Cell Lymphoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Oncology Ljubljana
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Structured Neurocognitive Assessment Battery
- Psychometric Questionnaires
- CSF Biomarker Analysis
Treatment groups
3 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov