ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS)

Not Applicable

• Conditions: Lung Cancer

• Registration Number: NCT05117372
• Lead Sponsor: Centre Chirurgical Marie Lannelongue

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-17
• Status Verified: 2021-08
• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-11-02
• Last Update Submitted: 2021-11-02
• Study First Posted: 2021-11-11
• Last Update Posted: 2021-11-11
• Primary Completion: 2022-08-17
• Study Completion: 2024-02-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Adult subject (≥ 18 years old)
• Patient having consented to the research

Group 1:

• Patient with cancer who was treated with immunotherapy
• Appearance of CT lung abnormalities during immunotherapy, not related to cancer
• With high suspicion of infiltrative lung disease:
• Pneumopathy (CTCAE version 5 classification).
• Patients requiring bronchial fibroscopy with BAL

Groups 2:

• Patient with lung cancer with peripheral tumor
• Requires surgical pulmonary lobectomy in the operating room

Exclusion Criteria

• Patient treated or having been treated in the last 2 months with corticosteroid therapy
• Patient treated with immunosuppressant and/or cyclophosphamide, and/or Anti-TNF α in the last 12 months
• Absence of consent
• Patient under curatorship, guardianship or safeguard of justice
• Pregnant woman
• Group 1:
• Patient with respiratory failure

Groups 2:

• Patient with lung cancer with proximal or endobronchial tumor
• Patients requiring bilobectomy or pneumonectomy
• Patient who has been treated with immunotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Expression levels of cellular and soluble actors involved in the occurrence of pulmonary toxicities associated with antitumor immunotherapies	1 day

Trial Locations

Locations (1)

Centre Chirurgical Marie Lannelongue; 🇫🇷 Le Plessis Robinson, France