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The number of patients affected by cancer and treated with immunotherapy is continuously increasing. With the advent of these new therapies, the investigators observe the emergence of new and unexpected toxicities. The care of patients treated with these molecules require the development of multidisciplinary skills and the introduction of a professional network capable of taking care of immunotherapy related toxicity (irAE) that can affect different organs and for which immediate and effective interventions are necessary for patient survival.
IMMUCARE-BASE will comprehensively enable the collection, of clinical and biological data of patients treated with anticancer immunotherapy. The creation of this database is essential to identify clinico-biological factors predisposing to toxicity, and to define the best strategies to prevent the early onset of irAE and/or to treat them. Ultimately, the objective of this database is to collect enough data to be able to personalise in the future the immunotherapy treatment according to the benefits and to anticipate risks for each patient.
The objective of the biological collection is to perform ancillary studies for understanding mechanism leading to toxicity and for the development of research programs in the field of immunotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with immunotherapy | Patients receiving for the first time an immunotherapy treatment for their cancer (Checkpoints inhibitors, such as PD-1 or PD-L1 or CTLA4…). Patients will be enrolled before starting the immunotherapy treatment and will be followed up for 5 years or until the permanent discontinuation of the immunotherapy treatment to describe the arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estimation of the incidence of the irAE | Other | Assessment of the incidence of the irAE in patients treated with immunotherapy at the Hospices Civils de Lyon (irAE of all grades and from all organs) and creation of a biological collection of blood, plasma, serum and PBMCs from patients before treatment, under treatment and at the onset of irAEs. |
| Measure | Description | Time Frame |
|---|---|---|
| Estimation of the incidence of immunotherapy-related toxicities (all grades, of all organs, in real life) in patients treated for the first time with anticancer immunotherapy and enrolled in the "IMMUCARE-BASE" clinical database | Patients can be treated with immunotherapy alone, or in association with other immunotherapies, or association with chemotherapies, targeted therapies or radiotherapy. It will include all types of cancers that can be treated with immunotherapy, also including patients that are in clinical trials. | 10 years |
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Inclusion Criteria:
Inclusion criteria specific to the biological collection:
-Signature of the informed consent.
Exclusion Criteria:
Exclusion criteria for the biological collection:
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Adult patients with cancer and starting anticancer immunotherapy (-immune checkpoint inhibitors: anti-PD-1, anti-PD-L1, anti-CTLA4, anti-Lag-3, anti-Tim-3, anti-TIGIT or other new emerging immune checkpoint inhibitors).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan LOPEZ, MD | Contact | +33 4 78 86 16 07 | +33 | jonathan.lopez@chu-lyon.fr |
| Sara CALATTINI, PhD | Contact | +33 4.78.86.37.79 | +33 | sara.calattini@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan LOPEZ, MD | Hospices Civils de Lyon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital L. Pradel | Not yet recruiting | Bron | France |
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Peripheral blood samples (36 mL) will be collected at the time of the first and second immunotherapy administrations, during routine care. In the case of grade 3 or 4 toxicities, blood samples will be collected as well at the time of irAE onset.
|
| Hôpital Pierre Wertheimer | Not yet recruiting | Bron | France |
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| Hôpital de la Croix Rousse | Not yet recruiting | Lyon | France |
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| Hôpital E Herriot | Not yet recruiting | Lyon | France |
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| Centre Hospitalier LYON SUD | Recruiting | Pierre-Bénite | France |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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