Learn about Research & Clinical Trials
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Universitaire Ziekenhuizen Leuven|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Els Wauters, MD, PhD|
|Principal Investigator Affiliation||University Hospitals - KU Leuven|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Pneumonitis, Interstitial, Immunotherapy, Immune-related Adverse Events|
The investigators will apply single cell RNA- and TCR-sequencing on up to 5,000 single cells per sample. Additionally, cell surface protein expression can be integrated with the transcriptional information. Various bioinformatics pipelines, including Seurat, will be used to identify different cell clusters, which through marker gene expression will be assigned to known cell types, cellular subtypes or phenotypes. For instance, this will make it possible to monitor the abundance of PD-1/PD-L1 expressing T-cells, cytotoxic T-cells, immune-suppressive myeloid cells etc. The following parameters at single-cell level will be relevant, amongst others:
- - The composition and relative abundancies of established immune cell types (e.g. T cells (CD4+, CD8+ and regulatory subsets), NK cells, B cells, MDSCs, macrophages, neutrophils, dendritic cells).
- - Composition of all stromal cellular subtypes identified by single-cell transcriptomics.
- - A gene regulatory network for each cell type and cellular subtype (or cell state) will be established and master transcriptional regulators will be identified.
Cancer patients experiencing ICI-pneumonitis
: Radiotherapy induced pneumonitis
Cancer patients experiencing RT-pneumonitis
: TKI-induced pneumonitis
Cancer patients experiencing TKI-induced pneumonitis
Drug: - Immune checkpoint blockade
ICI, administered as standard-of-care treatment
Drug: - Targeted therapy
TKI, administered as standard-of-care treatment
Radiation: - Radiotherapy
RT, administered as standard-of-care treatment
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.