Diffuse Large B-Cell LymphomaNCT07443514
Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma
A study testing Structured Neurocognitive Assessment Battery, Psychometric Questionnaires and CSF Biomarker Analysis in people with Diffuse Large B-Cell Lymphoma, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- Structured Neurocognitive Assessment Battery, Psychometric Questionnaires and CSF Biomarker Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
Institute of Oncology Ljubljana
Ljubljana, 1000
Klavdija Korošec, +386 31630065, kkorosec@onko-i.si
About this study
Official title: Cognitive Impairment in Patients With Diffuse Large B-cell Lymphoma
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.
Read the detailed description
This is a prospective, non-randomized interventional diagnostic study conducted at the Institute of Oncology Ljubljana. The study does not assign or modify therapeutic regimens; chemotherapy is administered exclusively according to clinical indication.
The research intervention consists of a structured neurocognitive assessment protocol and biomarker analyses performed at predefined time points during treatment and follow-up.
Adult patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) will be enrolled into parallel groups based on clinically indicated treatment (systemic chemotherapy alone or systemic plus intrathecal chemotherapy). A comparison group of healthy relatives will also be included.
Cognitive function will be assessed at baseline (prior to treatment initiation), after the first chemotherapy cycle, and 12 months after treatment initiation. In patients receiving intrathecal chemotherapy, an additional cognitive assessment will be performed before the last intrathecal cycle.
Cerebrospinal fluid (CSF) biomarkers (phosphorylated tau, total tau, amyloid beta 40, amyloid beta 42, neurofilament light chain, GFAP) will be quantified in patients receiving intrathecal chemotherapy. CSF samples will be collected during clinically indicated lumbar punctures performed for therapeutic purposes. No additional lumbar punctures will be performed solely for research purposes.
The primary objective is to evaluate longitudinal changes in cognitive performance and to identify clinical and biological predictors of treatment-associated cognitive impairment.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- Structured Neurocognitive Assessment Battery, Psychometric Questionnaires, CSF Biomarker Analysis
- Keywords
- Diffuse large B-cell lymphoma, Chemotherapy-related cognitive impairment
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Chemotherapy-Related Cognitive Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Neurocognitive Assessment BatteryDiagnostic test
Standardized neurocognitive testing including Montreal Cognitive Assessment (MoCA), Short Cognitive Performance Test (KPSS), and selected CANTAB computerized tasks assessing attention, working memory, executive function, processing speed, and episodic memory. Assessments are performed at baseline (prior to treatment initiation), after the first chemotherapy cycle, and 12 months after treatment initiation.
Psychometric QuestionnairesDiagnostic test
Validated questionnaires assessing anxiety, depression, fatigue, cognitive complaints, and quality of life (HADS, HAM-D, FSS, FACT-Cog v3, EORTC QLQ-C30, ECOG Performance Status). Questionnaires are administered at predefined study time points.
CSF Biomarker AnalysisDiagnostic test
Quantification of cerebrospinal fluid biomarkers (phosphorylated tau, total tau, amyloid beta 40, amyloid beta 42, neurofilament light chain, GFAP). CSF samples are collected during clinically indicated lumbar punctures prior to intrathecal chemotherapy administration. No additional lumbar punctures are performed solely for research purposes.
| Study group | Role | What they receive |
|---|---|---|
| DLBCL - Systemic Chemotherapy (R-CHOP) | Experimental | 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. Receives: Diagnostic Test: Structured Neurocognitive Assessment Battery; Diagnostic Test: Psychometric Questionnaires |
| DLBCL - Systemic + Intrathecal Chemotherapy | Experimental | 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. Receives: Diagnostic Test: Structured Neurocognitive Assessment Battery; Diagnostic Test: Psychometric Questionnaires; Diagnostic Test: CSF Biomarker Analysis |
| Healthy Control Group (Relatives) | Experimental | 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. Receives: Diagnostic Test: Structured Neurocognitive Assessment Battery; Diagnostic Test: Psychometric Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function (MoCA Total Score)
Change in MoCA total score from baseline across follow-up assessments.
Measured: Baseline (within 7 days prior to treatment initiation)
Change in Cognitive Function (MoCA Total Score)
Change in MoCA total score from baseline across follow-up assessments.
Measured: After first chemotherapy cycle (Cycle 1 Day 14-21)
Change in Cognitive Function (MoCA Total Score)
Change in MoCA total score from baseline across follow-up assessments.
Measured: 12 months after treatment initiation (±4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment, non-randomized, diagnostic interventional study with three groups defined by clinically indicated treatment exposure (systemic chemotherapy, systemic plus intrathecal chemotherapy, and healthy controls).
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443514
- Sponsor's protocol ID
- OI-DVBL-CI-2022-675
- Other IDs
- KME-2022-675
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment in Patients With Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT07443514
- Acronym / sponsor ID
- OI-DVBL-CI-2022-675
- Conditions
- Diffuse Large B-Cell Lymphoma
- Keywords
- Diffuse large B-cell lymphoma, Chemotherapy-related cognitive impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, non-randomized interventional diagnostic study conducted at the Institute of Oncology Ljubljana. The study does not assign or modify therapeutic regimens; chemotherapy is administered exclusively according to clinical indication.
The research intervention consists of a structured neurocognitive assessment protocol and biomarker analyses performed at predefined time points during treatment and follow-up.
Adult patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) will be enrolled into parallel groups based on clinically indicated treatment (systemic chemotherapy alone or systemic plus intrathecal chemotherapy). A comparison group of healthy relatives will also be included.
Cognitive function will be assessed at baseline (prior to treatment initiation), after the first chemotherapy cycle, and 12 months after treatment initiation. In patients receiving intrathecal chemotherapy, an additional cognitive assessment will be performed before the last intrathecal cycle.
Cerebrospinal fluid (CSF) biomarkers (phosphorylated tau, total tau, amyloid beta 40, amyloid beta 42, neurofilament light chain, GFAP) will be quantified in patients receiving intrathecal chemotherapy. CSF samples will be collected during clinically indicated lumbar punctures performed for therapeutic purposes. No additional lumbar punctures will be performed solely for research purposes.
The primary objective is to evaluate longitudinal changes in cognitive performance and to identify clinical and biological predictors of treatment-associated cognitive impairment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel assignment, non-randomized, diagnostic interventional study with three groups defined by clinically indicated treatment exposure (systemic chemotherapy, systemic plus intrathecal chemotherapy, and healthy controls).
| Arm | Type | Receives |
|---|---|---|
| DLBCL - Systemic Chemotherapy (R-CHOP) | Experimental | Diagnostic Test: Structured Neurocognitive Assessment Battery, Diagnostic Test: Psychometric QuestionnairesAdult 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. |
| DLBCL - Systemic + Intrathecal Chemotherapy | Experimental | Diagnostic Test: Structured Neurocognitive Assessment Battery, Diagnostic Test: Psychometric Questionnaires, Diagnostic Test: CSF Biomarker AnalysisAdult 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. |
| Healthy Control Group (Relatives) | Experimental | Diagnostic Test: Structured Neurocognitive Assessment Battery, Diagnostic Test: Psychometric QuestionnairesAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Neurocognitive Assessment BatteryStandardized neurocognitive testing including Montreal Cognitive Assessment (MoCA), Short Cognitive Performance Test (KPSS), and selected CANTAB computerized tasks assessing attention, working memory, executive function, processing speed, and episodic memory. Assessments are performed at baseline (prior to treatment initiation), after the first chemotherapy cycle, and 12 months after treatment initiation. | Diagnostic test | DLBCL - Systemic + Intrathecal Chemotherapy, DLBCL - Systemic Chemotherapy (R-CHOP), Healthy Control Group (Relatives) |
| Psychometric QuestionnairesValidated questionnaires assessing anxiety, depression, fatigue, cognitive complaints, and quality of life (HADS, HAM-D, FSS, FACT-Cog v3, EORTC QLQ-C30, ECOG Performance Status). Questionnaires are administered at predefined study time points. | Diagnostic test | DLBCL - Systemic + Intrathecal Chemotherapy, DLBCL - Systemic Chemotherapy (R-CHOP), Healthy Control Group (Relatives) |
| CSF Biomarker AnalysisQuantification of cerebrospinal fluid biomarkers (phosphorylated tau, total tau, amyloid beta 40, amyloid beta 42, neurofilament light chain, GFAP). CSF samples are collected during clinically indicated lumbar punctures prior to intrathecal chemotherapy administration. No additional lumbar punctures are performed solely for research purposes. | Diagnostic test | DLBCL - Systemic + Intrathecal Chemotherapy |
Primary outcome
Cognitive Function (MoCA Total Score)
Time frame: Baseline (within 7 days prior to treatment initiation)
Change in MoCA total score from baseline across follow-up assessments.
Change in Cognitive Function (MoCA Total Score)
Time frame: After first chemotherapy cycle (Cycle 1 Day 14-21)
Change in MoCA total score from baseline across follow-up assessments.
Change in Cognitive Function (MoCA Total Score)
Time frame: 12 months after treatment initiation (±4 weeks).
Change in MoCA total score from baseline across follow-up assessments.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Neurocognitive Assessment Battery, Psychometric Questionnaires and CSF Biomarker Analysis in people with Diffuse Large B-Cell Lymphoma, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadja Novak Bošnjak (031630065, nnovak@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function (MoCA Total Score) (time frame: Baseline (within 7 days prior to treatment initiation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.