Cohort Study: Modelling Toxicity Processing in Patients Treated by Immunotherapy (MOTIVATE).

Study Overview
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Brief Summary
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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.

Official Title
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Cohort Study: Modelling Toxicity Processing in Patients Treated by Immunotherapy (MOTIVATE).

Conditions
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Solid Tumor

Intervention / Treatment
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* Other: Patients starting a treatment by ICI


Participation Criteria
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Eligibility Criteria
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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: Patient who must receive a treatment other than Immune Checkpoint Inhibitor Patient with contraindication to the use of a checkpoint inhibitor (e.g., auto immune disorders requiring an immunosuppressive therapy) Pregnant or breastfeeding women Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures Patient protected by law

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort of patients starting a treatment by ICI<br> | Other: Patients starting a treatment by ICI<br>* Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30) before treatment administration and during the 12 months of treatment period, at the following time points: every 6 weeks for treatment regimen administered every 2 or 3 weeks at Weeks 6, 12, 20, 24 for treatment regimen administered every 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of toxicities evaluated according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03 |  | 12 months by patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to appearance of toxicity |  | 12 months by patient | 
| Rate of patients for which treatment was restarted among those who had stopped treatment for the management of an immune-related Adverse Event (irAE) |  | 12 months by patient | 
| Quality of life using the QLQ-C30 questionnaire |  | 12 months by patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid tumor, Immune Checkpoint Inhibitor, immune-related Adverse Event