MedTrace Logo

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

NCT06192303 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 104

Last updated 2024-01-05

No results posted yet for this study

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.

Conditions

  • Immune Checkpoint Inhibitor Associated Pneumonia

Interventions

DIAGNOSTIC_TEST

Bronchoalveolar lavage and pathogen metagenomic sequencing

After the patient is enrolled, traditional pathogen testing will be improved, and the clinical physician will make a preliminary diagnosis based on routine pathogen testing, clinical manifestations, infection indicators, and imaging. Within 24 hours of initial diagnosis, bronchoalveolar lavage and pathogen metagenomic sequencing were performed, and BALF mNGS results were fed back to clinical physicians (without interfering with clinical decision-making). Clinical treatment data of patients were collected at 72 hours, 7 days, 14 days, and 28 days after the start of treatment, and follow-up and efficacy evaluation were conducted. Finally, a review committee consisting of two senior respiratory physicians and one imaging physician conducted a systematic review of cases to make the final diagnosis of enrolled patients (as the gold standard), analyzing the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of BALF mNGS in diagnosing CIP.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-05-01
Completion
2026-01-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06192303 on ClinicalTrials.gov