Diagnostic Biomarkers for Checkpoint Inhibitor-related Pneumonitis
Prospective Study of NMR-based Serum Metabolic Profiles for the Diagnosis of Checkpoint Inhibitor-related Pneumonitis
Zhou Chengzhi
60 participants
Jan 10, 2026
OBSERVATIONAL
Conditions
Summary
Checkpoint inhibitor-related pneumonitis (CIP) is a common fatal immune-related adverse events of PD-1/PD-L1 inhibitors. Early diagnosis of CIP is crucial for timely intervention and improved prognosis; however, the absence of precise and effective diagnostic techniques often leads to underdiagnosis and misdiagnosis. The investigators conducted a prospective clinical study to evaluate the effectiveness of ¹H-nuclear magnetic resonance (NMR)-based lipoprotein and metabolite analysis in diagnosing checkpoint inhibitor-related pneumonitis (CIP), aiming to improve its early diagnosis rate.
Eligibility
Inclusion Criteria7
- Patients with a pathological diagnosis of lung cancer;
- The subject has received at least one course of immune checkpoint inhibitor treatment;
- Capable of understanding and voluntarily signing an informed consent form.
- For the CIP group, the following additional criteria must be met:
- Highly suspected of having checkpoint inhibitor pneumonitis based on radiological abnormalities and/or pulmonary symptoms (including fever, cough, and dyspnea).
- For the Control group, the following additional criteria must be met:
- Has had no clinical symptoms or radiographic evidence suggestive of pneumonitis at enrollment or prior to enrollment.
Exclusion Criteria2
- Pulmonary lesions were definitively diagnosed as tumor progression, bacterial pneumonia, or pulmonary edema;
- Incomplete or missing follow-up data.
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07340892