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NCT07443514Recruiting

Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma

Source: ClinicalTrials.gov · Last updated 2 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
3 (estimated)
First submitted
11 Feb 2026
Start date
1 Jan 2022
Primary completion date
31 Dec 2026
Lead sponsor
Institute of Oncology Ljubljana
NCT number
NCT07443514

What you commit to

  • Study type: Interventional
  • Planned participants: 3
  • From 1 Jan 2022 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Severe cognitive impairment preventing completion of neurocognitive testing
  • Severe psychiatric disorder or neurological disease interfering with cognitive assessment

Other

  • Inability to understand study procedures or complete questionnaires
  • Refusal or inability to provide informed consent

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institute of Oncology Ljubljana
Coordinator of this site? Confirm its status
LjubljanaSloveniaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.