Blood mNGS for Diagnosing Invasive Pulmonary Fungal Disease in Hematologic Patients

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

NCT Number	NCT07511595
Lead Sponsor	Peking University People's Hospital Collaborators: Peking University First Hospital, Hebei Yanda Ludaopei Hospital, Chinese PLA General Hospital, The First Affiliated Hospital of Zhengzhou University, Shandong Provincial Hospital, Qilu Hospital of Shandong University, First Affiliated Hospital of Zhejiang University, KingMed Diagnostics
Conditions	Invasive Pulmonary Fungal Disease
Enrollment	1,000 participants
Start Date	2026-04
Primary Completion	2028-12 (estimated)
Study Completion	2029-07 (estimated)
Updated on ClinicalTrials.gov	2026-04-13