Cohort Study: Modelling Toxicity Processing in Patients Treated by Immunotherapy (MOTIVATE). (NCT03447483) | Clinical Trial Compass
CompletedNot Applicable
Cohort Study: Modelling Toxicity Processing in Patients Treated by Immunotherapy (MOTIVATE).
France150 participantsStarted 2018-04-20
Plain-language summary
This trial is a multicentric, prospective cohort study of 150 patients aiming to model evolution of toxicity over time in patients with solid tumor and starting first cycle of Immune Checkpoint Inhibitor (ICI) treatment.
The study will be conducted on a population of patients treated with ICI in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre.
The study data (immune-related adverse events) will be collected during each administration of the treatment.
A questionnaire will be completed by the patient before the treatment administrations.
Patients will be followed until disease progression or up to 12 months of treatment.
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
. Age \> or = 18 years old
. Patient with a solid tumor whatever the organ
. Patient receiving an Immune Checkpoint Inhibitor treatment
. Patient starting first cycle of Immune Checkpoint Inhibitor treatment whatever the treatment line
. Patient affiliated to the french social security system
. Patient must provide written informed consent prior to inclusion in the study and any study-specific procedure
Exclusion criteria
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
Prevalence of toxicities evaluated according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03