Identifying biomarkers of lung toxicity from cancer treatments
A Single-cell Approach to Identify Biomarkers of Pulmonary Toxicity for Immune Checkpoint Blockade
This study is trying to find specific markers in blood and lung fluid from cancer patients to see how cancer treatments might be causing lung problems, which could help doctors diagnose and treat these issues better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Flemish Brabant) |
| Trial ID | NCT04807127 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the immune cell composition in bronchoalveolar lavage fluid from cancer patients who have developed pneumonitis due to cancer therapies. By utilizing single-cell RNA and TCR sequencing, the study will characterize various immune cell types and their gene expression profiles. Additionally, it will explore the potential of identifying circulating biomarkers of immune checkpoint blockade toxicity through blood samples, facilitating non-invasive diagnostics. The findings could lead to the development of diagnostic biomarkers and therapeutic targets for managing treatment-related lung toxicity.
Who should consider this trial
Good fit: Ideal candidates include adult cancer patients experiencing or at risk of treatment-induced pneumonitis who are undergoing bronchoscopy with bronchoalveolar lavage.
Not a fit: Patients who are not undergoing bronchoscopy or those with unsuitable collected material for analysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into biomarkers that help predict and manage lung toxicity in cancer patients undergoing immunotherapy.
How similar studies have performed: While the approach of single-cell analysis in this context is innovative, similar studies have shown promise in identifying biomarkers for other immune-related adverse events.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Adult M/F/X (\>= 18 years) * Patients receiving or having received treatment per guidelines * Patients undergoing bronchoscopy with BAL, for possible cancer treatment-induced pneumonitis * Not included in other clinical trials * Signed informed consent form Exclusion criteria: • Collected material not suitable for further processing in this study (e.g. bad quality). This decision will be made in consultation with a lab technician and/or bio-informatician, specialized in single-cell analysis.
Where this trial is running
Leuven, Flemish Brabant
- Universitaire Ziekenhuizen Leuven — Leuven, Flemish Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Els Wauters, MD, PhD — University Hospitals - KU Leuven
- Study coordinator: Els Wauters, MD, PhD
- Email: els.wauters@uzleuven.be
- Phone: +3216340942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.