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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological collection | Biological | Blood samples will be collected only once at enrollment, before initiation of a checkpoint inhibitor. It will include:
|
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of severe autoimmune manifestations in patients treated with BMS checkpoint inhibitors. | Severe autoimmune manifestations is defined by :
| 2 years after inclusion |
| 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 |
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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.
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques-Eric GOTTENBERG, MD, PhD | University Hospital, Strasbourg, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopitaux universitaires de strasbourg | Strasbourg | Alsace | 67000 | France |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D018070 | Biological Specimen Banks |
| ID | Term |
|---|---|
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |
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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 |