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Prospective Study of NMR-based Serum Metabolic Profiles for the Diagnosis of Checkpoint Inhibitor-related Pneumonitis

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Chengzhi Zhou, MD
doctorzcz@163.com
81567329
Time Frame
Start Date: 2026-01-10
Estimated Completion Date: 2028-01-10
Participants
Target number of participants: 60
Treatments
Experimental group
Checkpoint inhibitor-related pneumonitis
Control group
Lung cancer patients who received immunotherapy but did not develop CIP
Related Therapeutic Areas
Sponsors
Leads: Zhou Chengzhi

This content was sourced from clinicaltrials.gov