A Single-cell Approach to Identify Biomarkers of Pulmonary Toxicity for Immune Checkpoint Blockade
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
The main goal of this prospective non-interventional exploratory monocentric study is to characterize the immune cell composition of bronchoalveolar lavage (BAL) fluid from cancer patients experiencing cancer therapy-induced pneumonitis on a single-cell scale. These mechanistic insights can directly lead to putative diagnostic biomarkers and therapeutic targets.
A second highly clinically relevant hypothesis is that single-cell profiling of blood samples will reveal circulating biomarkers of ICB toxicity, making non-invasive diagnosis feasible.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Patients experiencing cancer-treatment induced pneumonitis, undergoing bronchoscopy with BAL
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Immune checkpoint blockade
DrugICI, administered as standard-of-care treatment
Targeted therapy
DrugTKI, administered as standard-of-care treatment
Radiotherapy
RadiationRT, administered as standard-of-care treatment
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: ICI-pneumonitis1 intervention
Group B: Radiotherapy induced pneumonitis1 intervention
Group C: TKI-induced pneumonitis1 intervention
Trial outcomes
Primary outcomes
1
Immune cell proportions, as determined by scRNA-seq, present in ICI-/RT-/TKI-induced pneumonitis BAL fluid
By identifying and statistically comparing the percentages of immune cell subtypes present in ICI-/RT-/TKI-induced pneumonitis BAL fluid, we aim to i) understand which immune processes drive these adverse events ii) identify putative molecular biomarkers iii) identify putative therapeutic targets
Time frame
From date of inclusion until study completion, on average 2 years2
Differentially expressed genes in BAL fluid, as determined by scRNA-seq, discriminating ICI-/RT-/TKI-induced pneumonitis
By identifying differentially expressed genes in ICI- vs. RT- vs. TKI-induced pneumonitis BAL fluid, we aim to i) understand which immune processes drive these adverse events ii) identify putative molecular biomarkers iii) identify putative therapeutic targets
Time frame
From date of inclusion until study completion, on average 2 yearsSecondary outcomes
1
Immune cell proportions, as determined by scRNA-seq, present in ICI-/RT-/TKI-induced pneumonitis peripheral blood mononuclear cells
By identifying and statistically comparing the percentages of immune cell subtypes present in ICI-/RT-/TKI-induced pneumonitis peripheral blood mononuclear cells, we aim to i) understand which immune processes drive these adverse events ii) identify putative molecular biomarkers iii) identify putative therapeutic targets
Time frame
From date of inclusion until study completion, on average 2 years2
Differentially expressed genes in PBMC, as determined by scRNA-seq, discriminating ICI-/RT-/TKI-induced pneumonitis
By identifying differentially expressed genes in ICI- vs. RT- vs. TKI-induced pneumonitis PBMC, we aim to i) understand which immune processes drive these adverse events ii) identify putative molecular biomarkers iii) identify putative therapeutic targets
Time frame
From date of inclusion until study completion, on average 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
KU Leuven
Collaborator
Source ClinicalTrials.gov