Actively Recruiting
A Single-cell Approach to Identify Biomarkers of Pulmonary Toxicity for Immune Checkpoint Blockade
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
K
KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring the immune cell makeup of bronchoalveolar lavage (BAL) fluid from cancer patients who develop pneumonitis caused by cancer treatments such as immune checkpoint blockade (ICI), radiotherapy (RT), or tyrosine kinase inhibitors (TKI). This observational study aims to identify detailed immune cell profiles at the single-cell level, which may lead to new diagnostic biomarkers and treatment targets. Additionally, the study investigates whether single-cell analysis of blood samples can reveal non-invasive biomarkers for immune checkpoint blockade toxicity. The study uses advanced single-cell RNA and TCR sequencing techniques on up to 5,000 cells per sample from BAL fluid and peripheral blood mononuclear cells (PBMC). Researchers analyze gene expression and cell surface proteins to classify immune cells and their states, including T cells, NK cells, B cells, and myeloid cells. The study groups include cancer patients experiencing pneumonitis induced by immune checkpoint blockade, radiotherapy, or targeted therapy (TKI), all receiving standard-of-care treatments. Participants provide BAL fluid samples during bronchoscopy and blood samples for analysis. The study monitors immune cell proportions and gene expression changes in these samples over approximately two years from inclusion. Researchers use bioinformatics tools to characterize immune profiles linked to different types of treatment-induced pneumonitis. The study does not involve any investigational treatments but focuses on detailed immune profiling to improve understanding and diagnosis of therapy-related lung toxicity.
CONDITIONS
Brief Title
A Single-cell Approach to Identify Biomarkers of Pulmonary Toxicity for Immune Checkpoint Blockade
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male, female, or other gender, age 18 years or older
- Patients receiving or having received cancer treatment as per guidelines
- Patients undergoing bronchoscopy with bronchoalveolar lavage (BAL) for possible treatment-induced pneumonitis
- Not currently included in other clinical trials
- Signed informed consent form
You will not qualify if you...
- Collected sample material not suitable for further processing in this study, as determined by specialized lab personnel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 1 day
Participants undergo bronchoscopy with bronchoalveolar lavage (BAL) and blood sample collection to obtain cells for single-cell RNA sequencing and analysis.
1 visit (in-person) for sample collection
Duration - Up to 2 years
Participants are monitored over time to study immune cell proportions and gene expression changes associated with treatment-induced pneumonitis.
Follow-up visits as per routine clinical care; additional blood samples may be collected
Trial Site Locations
Total: 1 location
1
Universitaire Ziekenhuizen Leuven
Leuven, Flemish Brabant, Belgium, 3000
Actively Recruiting
Research Team
E
Els Wauters, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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