NCT07384897

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
425

participants targeted

Target at P75+ for not_applicable

Timeline
69mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Feb 2025Feb 2032

Study Start

First participant enrolled

February 17, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2032

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

5.8 years

First QC Date

January 26, 2026

Last Update Submit

January 26, 2026

Conditions

Keywords

lung cancerNon-Small Cell Lung CancerSarcoidosisChronic Obstructive Pulmonary DiseaseCOPDImmune CellsTumor MicroenvironmentImmune DysregulationImmunotherapyImmunotherapy ResistanceImmune ProfilingMyeloid CellsNeutrophilsDendritic CellsInflammationChronic InflammationImmune suppressionEmergency myelopoiesis

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    median Progression free survival

    Throughout the entire study, approximately during 7 years

Study Arms (6)

Patients with precancerous lung lesions

OTHER

Patients with precancerous lung lesions under clinical monitoring

Other: Peripheral Blood Collection for Immune Profiling

Lung cancer

ACTIVE COMPARATOR

Patients with a diagnosis of lung cancer (all stages)

Other: Peripheral Blood Collection for Immune Profiling

Sarcoidosis and COPD

OTHER

Patients with chronic inflammatory lung diseases

Other: Peripheral Blood Collection for Immune Profiling

Control group

OTHER

Control group of volunteers without known lung disease

Other: Peripheral Blood Collection for Immune Profiling

chronic granulomatous disease

OTHER

Children and adolescents weighing ≥10 kg with chronic granulomatous disease

Other: Peripheral Blood Collection for Immune Profiling

Adults undergoing orthopedic surgery following hip or femur fracture

OTHER

Bone Marrow of Adults undergoing orthopedic surgery following hip or femur fracture

Other: Peripheral Blood Collection for Immune Profiling

Interventions

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.

Adults undergoing orthopedic surgery following hip or femur fractureControl groupLung cancerPatients with precancerous lung lesionsSarcoidosis and COPDchronic granulomatous disease

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Systemic corticosteroid therapy \> 10 mg/day prednisone (or equivalent)
  • Refusal or inability to provide informed consent (or assent, when applicable)
  • Chronic inflammatory lung disease currently treated with immunosuppressive therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires saint Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (5)

  • 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.

MeSH Terms

Conditions

Lung NeoplasmsDiseaseSarcoidosisPulmonary Disease, Chronic ObstructiveCarcinoma, Non-Small-Cell LungInflammation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Frank Aboubakar Nana, MD; PhD

    Cliniques universistaires saint Luc

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: This is a translational, non-interventional study evaluating immune cell populations in patients with lung cancer, sarcoidosis, and COPD. Participants receive only standard clinical care; no experimental treatments are given. Biological samples (primarily blood and when available, tumor, bone morrow samples collected for clinical reasons) and associated clinical data are analyzed to investigate immune mechanisms related to tumor progression, chronic lung inflammation, and response or resistance to therapy. The study is exploratory and comparative across diseases. All treatment decisions are made independently by the treating physicians and are not influenced by study participation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 3, 2026

Study Start

February 17, 2025

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

February 17, 2032

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations