NCT07443514 Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma
| NCT ID | NCT07443514 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Oncology Ljubljana |
| Condition | Diffuse Large B-Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 3 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3 participants in total. It began in 2022-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07443514 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diffuse Large B-Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07443514 currently recruiting?
Yes, NCT07443514 is actively recruiting participants. Contact the research team at nnovak@onko-i.si for enrollment information.
Where is the NCT07443514 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT07443514 clinical trial?
NCT07443514 is sponsored by Institute of Oncology Ljubljana. The trial plans to enroll 3 participants.