Opportunistic Autoimmune Diseases
Conditions
Keywords
monoclonal anti-PD-1 immunotherapy, monoclonal anti-CTLA-4 immunotherapy, checkpoint inhibitors, autoimmune manifestations, patient reported outcome, oncology
Brief summary
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.
Interventions
BIOLOGICALBiological 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
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of severe autoimmune manifestations in patients treated with BMS checkpoint inhibitors. | 2 years after inclusion | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the gender for the two groups of patients | 2 years after inclusion | Comparison of the gender for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations) |
| Comparison of the body-mass index for the two groups of patients | 2 years after inclusion | 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) |
| Comparison of the types of cancer for the two groups of patients | 2 years after inclusion | 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) |
| Comparison of the number of previous lines of chemotherapy for the two groups of patients | 2 years after inclusion | 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) |
| Comparison of the age for the two groups of patients | 2 years after inclusion | Comparison of the age for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations) |
| Description of flares or worsening of pre-existing autoimmune diseases | 2 years after inclusion | 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) |
| Comparison of baseline predictive factors of autoimmune manifestations for the two groups of patients | 2 years after inclusion | 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) |
| Changes in patients' quality of life over time and the impacts of OASI | 2 years after inclusion | EQ-5D-5L general quality of life scores |
| Event-free survival of patients | 2 years after inclusion | Time that passes before first appearance of Opportunistic Autoimmunity Secondary to cancer Immunotherapy. The baseline is the onset of cancer immunotherapy. |
Countries
France
Outcome results
None listed