Clinical trial · Interventional
Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma
Cognitive Impairment in Patients With Diffuse Large B-cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CSF Biomarker Analysis | Diagnostic Test | — | UNRESOLVED |
| Psychometric Questionnaires | Diagnostic Test | — | UNRESOLVED |
| Structured Neurocognitive Assessment Battery | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- DLBCL - Systemic Chemotherapy (R-CHOP)
- description
- Adult patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) receiving standard systemic chemoimmunotherapy (R-CHOP) according to clinical indication. The study does not assign treatment. The research intervention consists of structured neurocognitive assessments and psychometric evaluations performed at predefined time points during treatment and follow-up.
- interventionNames
- Diagnostic Test: Structured Neurocognitive Assessment Battery
- Diagnostic Test: Psychometric Questionnaires
- type
- EXPERIMENTAL
- label
- DLBCL - Systemic + Intrathecal Chemotherapy
- description
- Adult patients with newly diagnosed DLBCL receiving systemic chemoimmunotherapy (R-CHOP) and additional intrathecal chemotherapy (methotrexate and cytarabine) according to clinical indication. The study does not determine treatment allocation. The research intervention consists of structured neurocognitive assessments and cerebrospinal fluid (CSF) biomarker analyses performed at predefined time points.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available