Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Immunological toxicities associated with immune checkpoint inhibitor (ICI) monoclonal antibodies are unpredictable autoimmune and inflammatory pathologies that can affect all treated patients. Some of these events are severe and occur in 15-20% of patients treated with Programmed Death 1 (PD-1) antibodies.
The study of cellular immunological characteristics within tissues affected by toxicities and the interactions between the different actors of these toxicities aims at improving the knowledge concerning the mechanisms of these toxicities, but also at being able to specify the unexpected effects of ICIs on cells of the immune system, outside the tumor microenvironment.
Diffuse infiltrative lung disease is one of the most frequent and severe toxicities encountered in patients treated with anti PD-(L)1; either for bronchial cancer, melanoma or any other type of cancer. Patients developing this type of complication benefit from cytological, bacteriological, mycological and molecular analyses of intra-alveolar constituents obtained by bronchoalveolar lavage (BAL) performed during bronchial fibroscopy as part of their routine care. These analyses help to confirm the diagnosis of alveolitis, to specify the cellular characteristics of alveolar inflammation and to eliminate differential diagnoses of ICI toxicity.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with with immunotherapy and developing diffuse infiltrative lung disease | Active Comparator | Group 1: Patients treated for cancer with immunotherapy and developing diffuse infiltrative lung disease |
|
| Patients not treated with immunotherapy and requiring carcinologic lobectomy | Placebo Comparator | Group 2: Patients with lung cancer not treated with immunotherapy and requiring carcinologic lobectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treatment with immunotherapy and diffuse infiltrative lung disease | Other | Patients treated with with immunotherapy and developing diffuse infiltrative lung disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Expression levels of cellular and soluble actors involved in the occurrence of pulmonary toxicities associated with antitumor immunotherapies | 1 day |
Not provided
Not provided
Inclusion Criteria:
Group 1:
Groups 2:
Exclusion Criteria:
Groups 2:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jérôme LE PAVEC, MD | Contact | 01.40.94.24.30 | J.lepavec@ghpsj.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Chirurgical Marie Lannelongue | Recruiting | Le Plessis-Robinson | 92350 | France |
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Patients requiring carcinologic lobectomy | Other | Patients requiring carcinologic lobectomy |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |