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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
150
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
CH ALBI
Albi, France
Ch Castres
Castres, France
Institut Regional Du Cancer de Montpellier (Icm)
Montpellier, France
Institut Curie
Paris, France
Hopital Larrey
Toulouse, France
Institut Universitaire Du Cancer de Toulouse - Oncopole
Toulouse, France
Prevalence of toxicities evaluated according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03
Time frame: 12 months by patient
Time to appearance of toxicity
Time frame: 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)
Time frame: 12 months by patient
Quality of life using the QLQ-C30 questionnaire
Time frame: 12 months by patient
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