Patient-Reported AutoImmunity Secondary to Cancer immunothErapy

Study Overview
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Brief Summary
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This is a real life observational longitudinal study aiming to identify autoimmune manifestations in patients treated with checkpoint inhibitors in mono or combo therapy in real life. The study is based on patients reported experience validated by physician, recruited in cancer centers in France with another data collection from a French healthcare data claims database and a biological collection.

Official Title
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Patient-Reported AutoImmunity Secondary to Cancer immunothErapy

Conditions
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Opportunistic Autoimmune Diseases

Intervention / Treatment
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* Biological: Biological collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient (over 18 year old) in France (DOM/TOM included), starting a monoclonal anti-PD-1 and/or anti-CTLA-4 immunotherapy for a cancer, whatever the cancer, within the Marketing Authorization. As this research will be funded by BMS, for the e-Cohort, we will consider only patients treated by a BMS monoclonal antibody, to date: Ipilimumab (YERVOY©), Nivolumab (OPDIVO©) and Combo according to SmPCs. All patients (anonymous) with a reimbursed checkpoint inhibitor drug in SNDS will be included for the healthcare database claims study. Included patients should be able to understand and fill in questionnaires in French and should give informed consent and contact details, they should be able to read and answer emails in French. French Healthcare insurance beneficiary, whatever the scheme is. Exclusion Criteria: Patients in all interventional clinical trials, with exclusion from other studies specifically mentioned Patients deprived of liberty or guardianship Women of childbearing potential with a desire of becoming pregnant Major patients under tutorship. Patients with dementia or drug addiction Patients with no regular access to internet and phone

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Biological collection|Blood samples will be collected only once at enrollment, before initiation of a checkpoint inhibitor. It will include: DNA samples collection RNA samples collection Blood sample collection|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of severe autoimmune manifestations in patients treated with BMS checkpoint inhibitors. | Severe autoimmune manifestations is defined by : Discontinuation (temporary or definitive) of the cancer immunotherapy related to Autoimmunity or requirement for treatment due to auto-immune manifestations according to expert judgement or hospitalization for autoimmune manifestations or death related to autoimmune manifestations | 2 years after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the age for the two groups of patients | Comparison of the age for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations) | 2 years after inclusion | 
| Comparison of the gender for the two groups of patients | Comparison of the gender for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations) | 2 years after inclusion | 
| Comparison of the body-mass index for the two groups of patients | Comparison of the body-mass index for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations) | 2 years after inclusion | 
| Comparison of the types of cancer for the two groups of patients | Comparison of the types of cancer for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations) | 2 years after inclusion | 
| Comparison of the number of previous lines of chemotherapy for the two groups of patients | Comparison of the number of previous lines of chemotherapy for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations) | 2 years after inclusion | 
| Event-free survival of patients | Time that passes before first appearance of Opportunistic Autoimmunity Secondary to cancer Immunotherapy. The baseline is the onset of cancer immunotherapy. | 2 years after inclusion | 
| Description of flares or worsening of pre-existing autoimmune diseases | Pre-existing autoimmune disease will be defined by expert judgement on history of autoimmunity ongoing activity and blood analysis (preexisting autoantibodies will be investigated using biobanked serum) | 2 years after inclusion | 
| Comparison of baseline predictive factors of autoimmune manifestations for the two groups of patients | Assessment of the prevalence of preexisting autoantibodies before immune checkpoint inhibitor initiation for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations) | 2 years after inclusion | 
| Changes in patients' quality of life over time and the impacts of OASI | EQ-5D-5L general quality of life scores | 2 years after inclusion | 
| Changes in patients' quality of life over time and the impacts of OASI | EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) | 2 years after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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monoclonal anti-PD-1 immunotherapy, monoclonal anti-CTLA-4 immunotherapy, checkpoint inhibitors, autoimmune manifestations, patient reported outcome, oncology