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Multimodal Early Detection of CAR T-Cell-Associated Neurotoxicity

Multimodal Early Detection of CAR T-Cell-Associated Neurotoxicity

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00037737
Enrollment
60
Registered
2025-09-24
Start date
2025-06-12
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C91 D47 C82 C83 C85 C90

Interventions

Group 1: During the primary inpatient phase following CAR-T cell therapy, neurological monitoring is conducted using the Immune Effector Cell Encephalopathy (ICE) score, assessed both through the esta

Sponsors

Medizinische Fakultät der TU Dresden, Medizinische Klinik I
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Indication for CAR T-cell therapy - Signed consent form for participation in oncological research at University Hospital Dresden

Exclusion criteria

Exclusion criteria: - Inability to consent - Language barrier - Reduced cognitive or physical ability to use the app or complete smell tests

Design outcomes

Primary

MeasureTime frame
Proportion of successfully completed and documented ICE score assessments using digital monitoring compared to the paper-based method within 10 days after CAR T-cell infusion during the inpatient stay

Secondary

MeasureTime frame
- Time required per assessment as a sample measurement: comparison of the time needed between the digital and paper-based methods - User satisfaction: evaluation of satisfaction among users (e.g., nursing staff and physicians) using standardized questionnaires - Accuracy and consistency: concordance of results between the digital and paper-based methods - Proportion of successfully completed standardized smell tests relative to the planned number of tests - Correlation between smell test results and the occurrence of ICANS

Countries

Germany

Contacts

Public ContactMartin Schneider

Medizinische Fakultät der TU Dresden, Medizinische Klinik I

martin.schneider3@ukdd.de+49 351 458 18127

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026