ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy
CARTePRO
1 other identifier
observational
11
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 21, 2022
CompletedFirst Submitted
Initial submission to the registry
April 25, 2022
CompletedFirst Posted
Study publicly available on registry
May 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedApril 19, 2024
April 1, 2024
3.1 years
April 25, 2022
April 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response time
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.
84 day +/- 6 days
Secondary Outcomes (5)
Occurrence of CRS-related adverse events (ePRO)
84 day +/- 6 days
Number and severity of adverse events (AE) according to the CTCAE
84 day +/- 6 days
Occurrence and type of therapy-associated unplanned consultations
84 day +/- 6 days
Adherence
84 day +/- 6 days
Well-being
84 day +/- 6 days
Study Arms (1)
CAR T Cell Treatment
Interventions
This is an observational study using the Consilium CareTM smartphone ePRO application.
Eligibility Criteria
Patients 18 years or older receiving CAR T Cell therapy and congnitive ability to utilitze a smartphone.
You may qualify if:
- Signed ICF
- Patients \> 18 years
- Patients receiving CAR T cell treatment
- Personal smartphone with iOS or Android system. The operating system must be updated to one of the two newest main versions.
You may not qualify if:
- 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.
- Patients with insufficient knowledge about the use of a smartphone.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stiftung Swiss Tumor Institutelead
- Klinik Hirslanden, Zurichcollaborator
- Palleos Healthcare GmbHcollaborator
Study Sites (1)
Klinik für Hämatologie und Onkologie
Zurich, 8032, Switzerland
Study Officials
- PRINCIPAL INVESTIGATOR
Panagiotis Samaras, PD.Dr.med
Klinik für Hämatologie und Onkologie
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2022
First Posted
May 2, 2022
Study Start
March 21, 2022
Primary Completion
April 30, 2025
Study Completion
April 30, 2025
Last Updated
April 19, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share