NCT07340892 Diagnostic Biomarkers for Checkpoint Inhibitor-related Pneumonitis
| NCT ID | NCT07340892 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhou Chengzhi |
| Condition | Checkpoint Inhibitor-related Pneumonitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-01-10 |
| Primary Completion | 2027-01-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2026-01-10 with a primary completion date of 2027-01-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07340892 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Checkpoint Inhibitor-related Pneumonitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07340892 currently recruiting?
Yes, NCT07340892 is actively recruiting participants. Contact the research team at doctorzcz@163.com for enrollment information.
Where is the NCT07340892 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07340892 clinical trial?
NCT07340892 is sponsored by Zhou Chengzhi. The trial plans to enroll 60 participants.