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Cohort Study: Modelling Toxicity Processing in Patients Treated by Immunotherapy (MOTIVATE).
Sponsor: Institut Claudius Regaud
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2018-04-20
Completion Date
2020-06-18
Last Updated
2026-09-17
Healthy Volunteers
No
Conditions
Interventions
Patients starting a treatment by ICI
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
Locations (6)
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