Clinical trial · Observational
ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy
ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy: Feasibility Study (CARTePRO)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed as a feasibility study implementing electronic Patient Reported Outcomes (ePRO) in CAR T treatment for hematological malignancies, in order to describe AE reporting. ePRO assessments will be explored for their feasibility to engage in monitoring and management of CAR T-related toxicities as well as using these digital ePRO tools may improve both, its safety and accessibility.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CAR T-Cell Therapy | — | UNRESOLVED | — |
| Patient Reported Outcome Measures | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Consilium CareTM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- CAR T Cell Treatment
- interventionNames
- Device: Consilium CareTM
Primary outcomes (1)
- measure
- Response time
- timeFrame
- 84 day +/- 6 days
- description
- Response time in seconds obtained during trail-making test (ePRO) according to daily administration via consilium careTM app, as a potential indicator for ICANS and other CAR T cell therapy-related adverse events.
Secondary outcomes (5)
- measure
- Occurrence of CRS-related adverse events (ePRO)
- timeFrame
- 84 day +/- 6 days
- description
- Occurrence of CRS-related adverse events (ePRO): fever, myalgia, rigors, fatigue, and loss of appetite
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed ICF 2. Patients \> 18 years 3. Patients receiving CAR T cell treatment 4. Personal smartphone with iOS or Android system. The operating system must be updated to one of the two newest main versions. Exclusion Criteria: 1. Patients, whose compliance to the studies' protocol, e.g. due to mental health problems, physical problems, or the private life situation, can be justifiably doubted. 2. Patients with insufficient knowledge about the use of a smartphone.
References
Publications (0)
Data not yet available