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Memory and Thinking Problems in People With Diffuse Large B-Cell Lymphoma

Studies thinking changes during chemotherapy in adults with diffuse large B-cell lymphoma.

Key facts

Who runs it
Institute of Oncology Ljubljana
Where
Ljubljana, SloveniaSee the site
Trial code
Registry title
Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma
Status
Recruiting
People taking part
3 people, planned
Started
1 Jan 2022
Expected to end
31 Dec 2026
Type of study
Interventional, 3 groups
Treatments tested
  • Structured Neurocognitive Assessment Battery
  • Psychometric Questionnaires
  • CSF Biomarker Analysis
Record updated
2 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with newly diagnosed diffuse large B-cell lymphoma (DLBCL) who will get R-CHOP chemotherapy. It studies thinking and memory changes during treatment. Relatives of patients can join as a comparison group.

Age
18 to 80 years
Sex
All sexes can join.
Disease stage
Newly diagnosed diffuse large B-cell lymphoma (DLBCL), planned for treatment with systemic chemotherapy (R-CHOP), with or without intrathecal chemotherapy.

Main reasons for not taking part

  • Severe cognitive impairment that prevents completing the thinking tests
  • Severe psychiatric disorder or neurological disease that interferes with the cognitive assessment
  • Cannot understand the study procedures or complete the questionnaires
  • Refusal or inability to give informed consent

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 in Slovenia

  • Institute of Oncology LjubljanaLjubljana, SloveniaContact: Klavdija KorošecTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • DLBCL - Systemic Chemotherapy (R-CHOP)Treatment being tested

    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.

    Treatment: Structured Neurocognitive Assessment Battery and Psychometric Questionnaires

  • DLBCL - Systemic + Intrathecal ChemotherapyTreatment being tested

    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.

    Treatment: Structured Neurocognitive Assessment Battery, Psychometric Questionnaires, and CSF Biomarker Analysis

  • Healthy Control Group (Relatives)Treatment being tested

    Adult relatives of participating patients without DLBCL serving as a comparison group. Participants undergo structured neurocognitive testing and psychometric evaluation only. No invasive procedures are performed.

    Treatment: Structured Neurocognitive Assessment Battery and Psychometric Questionnaires

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Cognitive Impairment in Patients With Diffuse Large B-cell Lymphoma
Plain-language title
Memory and Thinking Problems in People With Diffuse Large B-Cell LymphomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 March 2026