Diagnostic Biomarkers for Checkpoint Inhibitor-related Pneumonitis

NCT07340892 | Recruiting

• 1 other identifier: CROC202601
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Checkpoint Inhibitor-related Pneumonitis

Keywords

Checkpoint inhibitor-related pneumonitis; ¹H-nuclear magnetic resonance; Metabolism

Outcome Measures

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.

  Blood sampling for testing within 1 day after enrollment.

Study Arms (2)

Experimental group

Checkpoint inhibitor-related pneumonitis

Control group

Lung cancer patients who received immunotherapy but did not develop CIP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective, dual-cohort, biomarker discovery study

You may qualify if:

• 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.

You may not qualify if:

• Pulmonary lesions were definitively diagnosed as tumor progression, bacterial pneumonia, or pulmonary edema;
• Incomplete or missing follow-up data.

Sponsors & Collaborators

• Zhou Chengzhi: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510100, China

RECRUITING

Central Study Contacts

Chengzhi Zhou, MD

CONTACT

81567329; doctorzcz@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 14, 2026
• Study Start: January 10, 2026
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): January 10, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)