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A Single-cell Approach to Identify Biomarkers of Pulmonary Toxicity for Immune Checkpoint Blockade

NCT04807127 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-07-01

No results posted yet for this study

Summary

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.

Conditions

  • Pneumonitis, Interstitial
  • Immunotherapy
  • Immune-related Adverse Events

Interventions

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

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Els Wauters, MD, PhD · University Hospitals - KU Leuven

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04807127 on ClinicalTrials.gov