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ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS)

NCT05117372 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-11-11

No results posted yet for this study

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.

Conditions

Interventions

OTHER

treatment with immunotherapy and diffuse infiltrative lung disease

Patients treated with with immunotherapy and developing diffuse infiltrative lung disease

OTHER

Patients requiring carcinologic lobectomy

Patients requiring carcinologic lobectomy

Sponsors & Collaborators

  • Centre Chirurgical Marie Lannelongue

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-17
Primary Completion
2022-08-17
Completion
2024-02-17

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05117372 on ClinicalTrials.gov