- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07384897
Immune Cells Role in Lung Cancer and Their Use in Anticancer Immunotherapies and Inflammatory Lung Disease (IMMUNOPUMON2)
This study aims to better understand the role of immune system cells in lung diseases such as lung cancer, sarcoidosis, and chronic obstructive pulmonary disease (COPD).
The investigators are studying how these immune cells can sometimes help the body defend itself, but in other cases may contribute to cancer growth or long-term lung inflammation.
Although recent treatments like immunotherapy have improved cancer care, only a small proportion of patients currently benefit from these therapies. One goal of this research is to understand why some patients do not respond or develop resistance to treatment.
The knowledge gained from this study may help researchers develop more effective and personalized treatments for people with lung diseases in the future.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Frank Aboubakar Nana, MD; PhD
- Phone Number: 0032 2 764 85 19
- Email: frank.aboubakar@saintluc.uclouvain.be
Study Contact Backup
- Name: Kim Henquin, Study nurse
- Phone Number: 0032 2 764 42 26
- Email: kim.henquin@saintluc.uclouvain.be
Study Locations
-
-
-
Brussels, Belgium, 1200
- Recruiting
- Cliniques Universitaires Saint Luc
-
Contact:
- Kim Henquin, Study nurse
- Phone Number: 0032 2 764 42 26
- Email: kim.henquin@saintluc.uclouvain.be
-
Contact:
- Frank Aboubakar Nana, MD; PhD
- Phone Number: 0032 2 764 85 19
- Email: frank.aboubaka@saintluc.uclouvain.be
-
Principal Investigator:
- Frank Aboubakar Nana, MD; PhD
-
Sub-Investigator:
- Valerie Lacroix, MD; PhD
-
Sub-Investigator:
- Delphine Hoton, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of lung cancer
- Presence of precancerous lung lesions
- Patients with a chronic inflammatory lung disease (sarcoidosis or chronic obstructive pulmonary disease [COPD]) prior to any treatment
- Control group: individuals without known lung disease
- Children and adolescents weighing ≥ 10 kg with genetically confirmed chronic granulomatous disease (CGD)
- Adults scheduled to undergo orthopedic surgery during which a bone marrow sample will be collected
Exclusion Criteria:
- Systemic corticosteroid therapy > 10 mg/day prednisone (or equivalent)
- Acute infection at the time of inclusion
- Refusal or inability to provide informed consent (or assent, when applicable)
- Chronic inflammatory lung disease currently treated with immunosuppressive therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patients with precancerous lung lesions
Patients with precancerous lung lesions under clinical monitoring
|
Participants provide biological samples for immune profiling and translational research.
Samples include peripheral blood and, when available from routine clinical care, additional specimens such as tumor tissue or rlymph node, bone marrow.
No experimental treatments are given.
Collected samples are analyzed to characterize immune cell populations and their functional and molecular features, with the aim of studying immune mechanisms involved in lung cancer, sarcoidosis, and COPD, as well as factors associated with disease progression and treatment response.
All medical care and treatment decisions remain independent of study participation.
|
|
Active Comparator: Lung cancer
Patients with a diagnosis of lung cancer (all stages)
|
Participants provide biological samples for immune profiling and translational research.
Samples include peripheral blood and, when available from routine clinical care, additional specimens such as tumor tissue or rlymph node, bone marrow.
No experimental treatments are given.
Collected samples are analyzed to characterize immune cell populations and their functional and molecular features, with the aim of studying immune mechanisms involved in lung cancer, sarcoidosis, and COPD, as well as factors associated with disease progression and treatment response.
All medical care and treatment decisions remain independent of study participation.
|
|
Other: Sarcoidosis and COPD
Patients with chronic inflammatory lung diseases
|
Participants provide biological samples for immune profiling and translational research.
Samples include peripheral blood and, when available from routine clinical care, additional specimens such as tumor tissue or rlymph node, bone marrow.
No experimental treatments are given.
Collected samples are analyzed to characterize immune cell populations and their functional and molecular features, with the aim of studying immune mechanisms involved in lung cancer, sarcoidosis, and COPD, as well as factors associated with disease progression and treatment response.
All medical care and treatment decisions remain independent of study participation.
|
|
Other: Control group
Control group of volunteers without known lung disease
|
Participants provide biological samples for immune profiling and translational research.
Samples include peripheral blood and, when available from routine clinical care, additional specimens such as tumor tissue or rlymph node, bone marrow.
No experimental treatments are given.
Collected samples are analyzed to characterize immune cell populations and their functional and molecular features, with the aim of studying immune mechanisms involved in lung cancer, sarcoidosis, and COPD, as well as factors associated with disease progression and treatment response.
All medical care and treatment decisions remain independent of study participation.
|
|
Other: chronic granulomatous disease
Children and adolescents weighing ≥10 kg with chronic granulomatous disease
|
Participants provide biological samples for immune profiling and translational research.
Samples include peripheral blood and, when available from routine clinical care, additional specimens such as tumor tissue or rlymph node, bone marrow.
No experimental treatments are given.
Collected samples are analyzed to characterize immune cell populations and their functional and molecular features, with the aim of studying immune mechanisms involved in lung cancer, sarcoidosis, and COPD, as well as factors associated with disease progression and treatment response.
All medical care and treatment decisions remain independent of study participation.
|
|
Other: Adults undergoing orthopedic surgery following hip or femur fracture
Bone Marrow of Adults undergoing orthopedic surgery following hip or femur fracture
|
Participants provide biological samples for immune profiling and translational research.
Samples include peripheral blood and, when available from routine clinical care, additional specimens such as tumor tissue or rlymph node, bone marrow.
No experimental treatments are given.
Collected samples are analyzed to characterize immune cell populations and their functional and molecular features, with the aim of studying immune mechanisms involved in lung cancer, sarcoidosis, and COPD, as well as factors associated with disease progression and treatment response.
All medical care and treatment decisions remain independent of study participation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression free survival
Time Frame: Throughout the entire study, approximately during 7 years
|
median Progression free survival
|
Throughout the entire study, approximately during 7 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Frank Aboubakar Nana, MD; PhD, Cliniques universistaires saint Luc
Publications and helpful links
General Publications
- Desai A, Prasad V. Low-Dose Computed Tomographic Screening for Lung Cancer: Time to Implement or Unresolved Questions? J Gen Intern Med. 2021 Oct;36(10):3202-3204. doi: 10.1007/s11606-021-06806-5. Epub 2021 Apr 26. No abstract available.
- Haslam A, Prasad V. Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs. JAMA Netw Open. 2019 May 3;2(5):e192535. doi: 10.1001/jamanetworkopen.2019.2535.
- Delhez N, Aboubakar Nana F, Houbion C, Bayard A, Bruger A, Vanhaver C, Brandau S, van der Bruggen P, Hirsch T. Deciphering neutrophil heterogeneity in human blood and tumors: Methods for isolating neutrophils and assessing their effect on T-cell proliferation. Methods Cell Biol. 2025;191:151-196. doi: 10.1016/bs.mcb.2024.10.010. Epub 2024 Nov 25.
- Bruger AM, Dorhoi A, Esendagli G, Barczyk-Kahlert K, van der Bruggen P, Lipoldova M, Perecko T, Santibanez J, Saraiva M, Van Ginderachter JA, Brandau S. How to measure the immunosuppressive activity of MDSC: assays, problems and potential solutions. Cancer Immunol Immunother. 2019 Apr;68(4):631-644. doi: 10.1007/s00262-018-2170-8. Epub 2018 May 21.
- Vanhaver C, Aboubakar Nana F, Delhez N, Luyckx M, Hirsch T, Bayard A, Houbion C, Dauguet N, Brochier A, van der Bruggen P, Bruger AM. Immunosuppressive low-density neutrophils in the blood of cancer patients display a mature phenotype. Life Sci Alliance. 2023 Nov 6;7(1):e202302332. doi: 10.26508/lsa.202302332. Print 2024 Jan.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Inflammation
- Non-Small Cell Lung Cancer
- COPD
- lung cancer
- Immunotherapy
- Chronic Inflammation
- Chronic Obstructive Pulmonary Disease
- Immune Dysregulation
- Sarcoidosis
- Neutrophils
- Tumor Microenvironment
- Dendritic Cells
- Immunotherapy Resistance
- Immune Cells
- Immune suppression
- Myeloid Cells
- Immune Profiling
- Emergency myelopoiesis
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Chronic Disease
- Disease Attributes
- Immune System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Hypersensitivity
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Hypersensitivity, Delayed
- Pathological Conditions, Signs and Symptoms
- Hemic and Lymphatic Diseases
- Pulmonary Disease, Chronic Obstructive
- Lung Neoplasms
- Disease
- Inflammation
- Carcinoma, Non-Small-Cell Lung
- Sarcoidosis
Other Study ID Numbers
- IMMUNOPOUMON2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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