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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patients with a pathological diagnosis of lung cancer;
2. The subject has received at least one course of immune checkpoint inhibitor treatment;
3. Capable of understanding and voluntarily signing an informed consent form.
For the CIP group, the following additional criteria must be met:
4. 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:
5. Has had no clinical symptoms or radiographic evidence suggestive of pneumonitis at enrollment or prior to enrollment.
Exclusion Criteria:
1. Pulmonary lesions were definitively diagnosed as tumor progression, bacterial pneumonia, or pulmonary edema;
2. Incomplete or missing follow-up data.
Primary outcome measure(s)
Diagnostic performance — Blood sampling for testing within 1 day after enrollment. The Area Under the Receiver Operating Characteristic Curve (AUROC) of a classifier model derived from NMR serum metabolic profiles to distinguish between patients with confirmed checkpoint inhibitor-related pneumonitis and control patients on immunotherapy without pneumonitis.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Guangzhou Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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