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NCT07511595

Prospective Multicenter Study of Blood mNGS for Diagnosing Invasive Pulmonary Fungal Disease in Hematologic Patients

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn whether a blood test called metagenomic next-generation sequencing (mNGS) can help diagnose invasive pulmonary fungal disease in patients with blood disorders. It will also evaluate how accurate this test is compared to traditional methods. The main questions it aims to answer are: Can blood mNGS accurately identify the fungi causing lung infections? How well does blood mNGS perform compared to conventional tests (such as culture, serum markers, and imaging)? Does the mNGS result influence doctors' decisions to start, change, or stop antifungal treatment? This study is a multicenter, prospective, observational trial. Researchers will compare the mNGS test with standard diagnostic methods to assess its usefulness in early diagnosis of fungal lung infections. Participants will: Have a blood sample collected within 72 hours of enrollment for mNGS testing Undergo routine clinical tests, including imaging, serum markers, and cultures, as part of standard care Be followed for 42 days to collect information on treatment and clinical outcomes

Official title: Prospective Multicenter Clinical Study of Blood Microbial Metagenomic Next-Generation Sequencing (mNGS) for the Diagnosis of Invasive Pulmonary Fungal Disease in Patients With Hematologic Diseases

Key Details

Gender

All

Age Range

14 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2026-04

Completion Date

2029-07

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

OTHER

Blood microbial metagenomic next-generation sequencing (mNGS)

Blood samples will be collected and analyzed using microbial metagenomic next-generation sequencing (mNGS) technology for the detection of invasive pulmonary fungal pathogens.