Cognitive changes in people treated for diffuse large B‑cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Institute of Oncology Ljubljana
  Ljubljana, Slovenia Recruiting

Study contacts

• Study coordinator: Nadja Novak Bošnjak
• Email: nnovak@onko-i.si
• Phone: 031630065

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.