ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS) (LBA-PI)
Primary Purpose
Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
treatment with immunotherapy and diffuse infiltrative lung disease
Patients requiring carcinologic lobectomy
Sponsored by
About this trial
This is an interventional health services research trial for Lung Cancer focused on measuring anti PD-(L)1, Diffuse infiltrative lung disease
Eligibility Criteria
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
Sites / Locations
- Centre Chirurgical Marie LannelongueRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Patients treated with with immunotherapy and developing diffuse infiltrative lung disease
Patients not treated with immunotherapy and requiring carcinologic lobectomy
Arm Description
Group 1: Patients treated for cancer with immunotherapy and developing diffuse infiltrative lung disease
Group 2: Patients with lung cancer not treated with immunotherapy and requiring carcinologic lobectomy
Outcomes
Primary Outcome Measures
Expression levels of cellular and soluble actors involved in the occurrence of pulmonary toxicities associated with antitumor immunotherapies
Secondary Outcome Measures
Full Information
NCT ID
NCT05117372
First Posted
August 6, 2021
Last Updated
November 2, 2021
Sponsor
Centre Chirurgical Marie Lannelongue
1. Study Identification
Unique Protocol Identification Number
NCT05117372
Brief Title
ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS)
Acronym
LBA-PI
Official Title
ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS) PERFORMED FOR INFILTRATIVE LUNG DISEASE THAT COMPLICATE ANTI PD-(L)1 IMMUNOTHERAPIES
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
August 17, 2022 (Anticipated)
Study Completion Date
February 17, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Chirurgical Marie Lannelongue
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
anti PD-(L)1, Diffuse infiltrative lung disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients treated with with immunotherapy and developing diffuse infiltrative lung disease
Arm Type
Active Comparator
Arm Description
Group 1: Patients treated for cancer with immunotherapy and developing diffuse infiltrative lung disease
Arm Title
Patients not treated with immunotherapy and requiring carcinologic lobectomy
Arm Type
Placebo Comparator
Arm Description
Group 2: Patients with lung cancer not treated with immunotherapy and requiring carcinologic lobectomy
Intervention Type
Other
Intervention Name(s)
treatment with immunotherapy and diffuse infiltrative lung disease
Intervention Description
Patients treated with with immunotherapy and developing diffuse infiltrative lung disease
Intervention Type
Other
Intervention Name(s)
Patients requiring carcinologic lobectomy
Intervention Description
Patients requiring carcinologic lobectomy
Primary Outcome Measure Information:
Title
Expression levels of cellular and soluble actors involved in the occurrence of pulmonary toxicities associated with antitumor immunotherapies
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jérôme LE PAVEC, MD
Phone
01.40.94.24.30
Email
J.lepavec@ghpsj.fr
Facility Information:
Facility Name
Centre Chirurgical Marie Lannelongue
City
Le Plessis Robinson
ZIP/Postal Code
92350
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS)
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