NCT07443514

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jan 2022Dec 2026

Study Start

First participant enrolled

January 1, 2022

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

February 11, 2026

Last Update Submit

February 27, 2026

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

Diffuse large B-cell lymphomaChemotherapy-related cognitive impairment

Outcome Measures

Primary Outcomes (3)

  • Cognitive Function (MoCA Total Score)

    Change in MoCA total score from baseline across follow-up assessments.

    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.

    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.

    12 months after treatment initiation (±4 weeks).

Study Arms (3)

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.

Diagnostic Test: Structured Neurocognitive Assessment BatteryDiagnostic 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.

Diagnostic Test: Structured Neurocognitive Assessment BatteryDiagnostic Test: Psychometric QuestionnairesDiagnostic 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.

Diagnostic Test: Structured Neurocognitive Assessment BatteryDiagnostic Test: Psychometric Questionnaires

Interventions

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.

DLBCL - Systemic + Intrathecal ChemotherapyDLBCL - Systemic Chemotherapy (R-CHOP)Healthy Control Group (Relatives)
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.

DLBCL - Systemic + Intrathecal ChemotherapyDLBCL - Systemic Chemotherapy (R-CHOP)Healthy Control Group (Relatives)
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.

DLBCL - Systemic + Intrathecal Chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseChemotherapy-Related Cognitive Impairment

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Nadja Novak Bošnjak

CONTACT

031630065nnovak@onko-i.si

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2026

First Posted

March 2, 2026

Study Start

January 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations

SL(1)