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NCT04807127
A Single-cell Approach to Identify Biomarkers of Pulmonary Toxicity for Immune Checkpoint Blockade
trial testing Immune checkpoint blockade in Pneumonitis, Interstitial in 60 participants. Currently enrolling.
31 January 2025
Quick facts
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 1 February 2020 |
| Primary completion | 31 January 2025 |
| Estimated completion | 31 January 2025 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Immune checkpoint blockade — full drug profile →
- Targeted therapy — full drug profile →
- Radiotherapy — full drug profile →
Conditions studied
- Pneumonitis, Interstitial — all drugs for Pneumonitis, Interstitial →
- Immunotherapy — all drugs for Immunotherapy →
- Immune-related Adverse Events — all drugs for Immune-related Adverse Events →
Sponsor
Universitaire Ziekenhuizen KU Leuven — full company profile →
Who can join
Adults 18 to 120, any sex, with Pneumonitis, Interstitial or Immunotherapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Facts and Hopes in Prediction, Diagnosis, and Treatment of Immune-Related Adverse Events.
Smithy JW, Faleck DM, Postow MA. · · 2022 · cited 25× · PMID 34921018 · DOI 10.1158/1078-0432.ccr-21-1240 -
Single-Cell Sequencing: Current Applications in Precision Onco-Genomics and Cancer Therapeutics.
Mustachio LM, Roszik J. · · 2022 · cited 18× · PMID 35158925 · DOI 10.3390/cancers14030657
Verify or expand the search:
- PubMed search for NCT04807127
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04807127 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universitaire Ziekenhuizen KU Leuven
- Last refreshed: 1 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04807127.
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