Patient Reported Outcome MeasuresCARTePRONCT05354973
ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy
An observational study of Patient Reported Outcome Measures and CAR T-Cell Therapy, run by Stiftung Swiss Tumor Institute at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Reported Outcome Measures, CAR T-Cell Therapy
- What is being tested?
- Consilium CareTM
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Mar 2022to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years or older receiving CAR T Cell therapy and congnitive ability to utilitze a smartphone.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Klinik für Hämatologie und Onkologie
Zurich, 8032
Panogiotis Samaras, PD. Dr.med., +0762323819, panagiotis.samaras@kho.ch
About this study
Official title: ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy: Feasibility Study (CARTePRO)
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.
- Being tested
- Consilium CareTM
- Keywords
- CAR T-Cell Therapy, ePRO, PRO, Patient Reported Outcome Measure, Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consilium CareTMDevice
This is an observational study using the Consilium CareTM smartphone ePRO application.
| Study group | Role | What they receive |
|---|---|---|
| CAR T Cell Treatment | Not described Receives: Device: Consilium CareTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 84 day +/- 6 days
Secondary outcomes (5)
Occurrence of CRS-related adverse events (ePRO)
Occurrence of CRS-related adverse events (ePRO): fever, myalgia, rigors, fatigue, and loss of appetite
Measured: 84 day +/- 6 days
Number and severity of adverse events (AE) according to the CTCAE
Number and severity of adverse events (AE) according to the Common Terminology Criteria for Adverse Events (CTCAE) after 12 weeks (ePRO).
CTCAE on a 5 point scale: Grade 1 is mild, grade 2 moderate, grade 3 severe, grade 4 life-threatening, and grade 5 corresponds to death. Grade 3 and higher correspond to the WHO definition of serious adverse drug reaction ("serious ADR").
Measured: 84 day +/- 6 days
Occurrence and type of therapy-associated unplanned consultations
Occurrence and type of therapy-associated unplanned consultations. Unplanned consultations are defined as additional consultations outside of planned therapy or control visits at the treatment center or with the investigator, as well as unplanned visits to other physicians or emergency services.
Measured: 84 day +/- 6 days
Adherence
Adherence, measured as percentage of days during intervention with electronically captured consilium careTM app usage
Measured: 84 day +/- 6 days
Well-being
Well-being according to the ECOG Performance Status as daily ePRO before and after CAR T cell reinfusion.
Measured: 84 day +/- 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start21 Mar 2022
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Reported Outcome MeasuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stiftung Swiss Tumor Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Klinik Hirslanden, Zurich, Palleos Healthcare GmbH
- Responsible party
- Sponsor
- Investigators
- Panagiotis Samaras, PD.Dr.med, Principal investigator, Klinik für Hämatologie und Onkologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354973
- Sponsor's protocol ID
- KEK ZH: 2021-D0077
- Acronym
- CARTePRO
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2022
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy: Feasibility Study (CARTePRO)
- ClinicalTrials.gov ID
- NCT05354973
- Acronym / sponsor ID
- CARTePRO / KEK ZH: 2021-D0077
- Keywords
- CAR T-Cell Therapy, ePRO, PRO, Patient Reported Outcome Measure, Immunotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Stiftung Swiss Tumor InstituteUniversity, hospital or other
- Collaborators
- Klinik Hirslanden, Zurich, Palleos Healthcare GmbH
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR T Cell Treatment | – | Device: Consilium CareTM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years or older receiving CAR T Cell therapy and congnitive ability to utilitze a smartphone.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consilium CareTMThis is an observational study using the Consilium CareTM smartphone ePRO application. | Device | CAR T Cell Treatment |
Primary outcome
Response time
Time frame: 84 day +/- 6 days
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.
5 secondary outcomes
Occurrence of CRS-related adverse events (ePRO)
Time frame: 84 day +/- 6 days
Number and severity of adverse events (AE) according to the CTCAE
Time frame: 84 day +/- 6 days
Occurrence and type of therapy-associated unplanned consultations
Time frame: 84 day +/- 6 days
Adherence
Time frame: 84 day +/- 6 days
Well-being
Time frame: 84 day +/- 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panagiotis Samaras, PD.Dr.med principal investigator
Klinik für Hämatologie und Onkologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Reported Outcome Measures and CAR T-Cell Therapy, run by Stiftung Swiss Tumor Institute at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Trojan, Prof.Dr.med (+41 76 343 02 00, trojan@1st.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response time (time frame: 84 day +/- 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.