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Blood mNGS for Diagnosing Invasive Pulmonary Fungal Disease in Hematologic Patients

NCT07511595 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-04-13

No results posted yet for this study

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

Conditions

  • Invasive Pulmonary Fungal Disease

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.

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

  • Peking University First Hospital

    collaborator OTHER

  • Hebei Yanda Ludaopei Hospital

    collaborator OTHER

  • Chinese PLA General Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER

  • KingMed Diagnostics

    collaborator UNKNOWN

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-12-31
Completion
2029-07-31

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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 NCT07511595 on ClinicalTrials.gov