Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma (NCT07443514) | Clinical Trial Compass
RecruitingNot Applicable
Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma
Slovenia3 participantsStarted 2022-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cognitive Function (MoCA Total Score)
Timeframe: Baseline (within 7 days prior to treatment initiation)
2
Change in Cognitive Function (MoCA Total Score)
Timeframe: After first chemotherapy cycle (Cycle 1 Day 14-21)
3
Change in Cognitive Function (MoCA Total Score)
Timeframe: 12 months after treatment initiation (±4 weeks).