Cognitive changes in people treated for diffuse large B‑cell lymphoma
Cognitive Impairment in Patients With Diffuse Large B-cell Lymphoma
This study tests whether adults with newly diagnosed diffuse large B‑cell lymphoma experience cognitive changes during and after standard chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT07443514 on ClinicalTrials.gov |
What this trial studies
This prospective, non-randomized diagnostic study follows adults with newly diagnosed DLBCL who receive standard systemic chemotherapy with or without intrathecal chemotherapy at the Institute of Oncology Ljubljana. Participants complete a structured neurocognitive test battery and psychometric questionnaires at baseline, after the first chemotherapy cycle, and 12 months after treatment start, with an additional assessment before the last intrathecal dose when applicable. In patients receiving intrathecal chemotherapy, cerebrospinal fluid collected during clinically indicated lumbar punctures will be analyzed for biomarkers such as phosphorylated tau, total tau, amyloid beta 40/42, neurofilament light chain, and GFAP. A comparison group of healthy relatives will provide normative data to help characterize the frequency, severity, and trajectory of treatment-associated cognitive changes and to identify clinical and biological predictors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–80 with newly diagnosed DLBCL scheduled for standard systemic chemotherapy (R‑CHOP) who can complete cognitive testing and provide informed consent, with relatives eligible as healthy controls.
Not a fit: Patients with severe cognitive impairment, major psychiatric or neurological disorders that prevent completion of testing, or those unable or unwilling to provide informed consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could help identify patients at higher risk for chemotherapy-related cognitive problems and inform monitoring or supportive care strategies.
How similar studies have performed: Previous observational work in cancer has documented chemotherapy-related cognitive changes, but combining longitudinal neurocognitive testing with CSF biomarker profiling specifically in DLBCL is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ljubljana
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Nadja Novak Bošnjak
- Email: nnovak@onko-i.si
- Phone: 031630065
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.