Diagnostic Biomarkers for Checkpoint Inhibitor-related Pneumonitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZhou Chengzhi
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Highly suspected of having checkpoint inhibitor pneumonitis based on radiological abnormalities and/or pulmonary symptoms (including fever, cough, and dyspnea).
Disqualifiers
Pulmonary lesions were definitively diagnosed as tumor progression, bacterial pneumonia, or pulmonary edema;
Incomplete or missing follow-up data.
Trial population
Prospective, dual-cohort, biomarker discovery study
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Experimental group
Group B: Control group
Trial outcomes
Primary outcomes
1
Diagnostic performance
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.
Time frame
Blood sampling for testing within 1 day after enrollment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhou Chengzhi
Lead sponsor
Guangzhou Institute of Respiratory Disease
Sponsor institution
Source ClinicalTrials.gov