Prospective Study on the Efficacy and Safety of Bronchoalveolar Lavage Combined With Pathogen Metagenomic Sequencing Technology in the Diagnosis of Immune Checkpoint Inhibitor Associated Pneumonia

Recruiting

• Conditions: Immune Checkpoint Inhibitor Associated Pneumonia
• Interventions: Diagnostic Test: Bronchoalveolar lavage and pathogen metagenomic sequencing

• Registration Number: NCT06192303
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

Immune checkpoint inhibitor associated pneumonia (CIP) is a common immune related adverse reaction, accounting for 35% of all deaths. However, due to the lack of typical clinical symptoms and imaging manifestations, CIP needs to be differentiated from other diseases such as pulmonary infections and lung cancer progression. Currently, there is a lack of diagnostic gold standards, which belongs to exclusive diagnosis. Empirical diagnosis and treatment in clinical practice can easily lead to the abuse of hormones and antibiotics, and even misdiagnosis and mistreatment, resulting in patient death. Therefore, early identification of CIP and pulmonary infection is the key to successful diagnosis and treatment. The CIP diagnosis and treatment guidelines recommend performing bronchoalveolar lavage as appropriate, but there is still a lack of large-scale prospective clinical studies. The beneficial pathogen metagenomic sequencing technology for the diagnosis of pulmonary infections has not been mentioned. Our research group conducted a prospective clinical study for the first time to evaluate the effectiveness and safety of bronchoalveolar lavage combined with pathogen metagenomic sequencing technology in diagnosing CIP, explore biomarkers for diagnosing CIP, in order to improve the early diagnosis rate and treatment efficiency of CIP, and reduce the abuse of antibiotics and hormones.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-12-14
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-03
• Last Update Submitted: 2024-01-03
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Primary Completion: 2025-05-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

1. Voluntarily sign an informed consent form;
2. Age range from 18 to 75 years old, regardless of gender;
3. Immunosuppressive host;
4. Symptoms, signs, or imaging signs of pneumonia are visible, and empirical anti infection treatment is ineffective.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CIP cohort	Bronchoalveolar lavage and pathogen metagenomic sequencing	-
non CIP cohort	Bronchoalveolar lavage and pathogen metagenomic sequencing	-

Primary Outcome Measures

Name	Time	Method
Positive predictive value (PPV), negative predictive value (NPV) in suspected CIP patients	2023.01-2026.01
Sensitivity, specificity in suspected CIP patients	2023.01-2026.01

Trial Locations

Locations (1)

Southern Medical University Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China