Blood mNGS for Diagnosing Invasive Pulmonary Fungal Disease in Hematologic Patients

Starting soon

Conditions studied: Invasive Pulmonary Fungal Disease

In brief

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

Key facts

Study ID

NCT07511595

Run by

Peking University People's Hospital

People needed

1000

Starts

2026-04-01

Expected to finish

2029-07-01

Last updated by the study team

2026-04-13

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥14 years, gender unrestricted.
• Patients diagnosed with hematologic malignancies (leukemia, lymphoma, myeloma, etc.) or those who have undergone autologous/allogeneic HSCT.
• Chest CT confirmed the presence of pulmonary lesions.
• Clinical suspicion of IFD (with symptoms such as fever, cough, and dyspnea).
• No other etiological evidence (blood culture, respiratory specimen PCR, etc.) was found.
• At least one high-risk factor for IFD is present: agranulocytosis (absolute neutrophil count <0.5×10⁹/L), long-term (≥2 weeks) use of glucocorticoids (prednisone equivalent dose ≥0.5 mg/kg/day), concurrent severe acute graft-versus-host disease (GVHD) or moderate-to-severe chronic graft-versus-host disease (cGVHD), cytomegalovirus (CMV) infection or activation, or treatment with T-cell immunosuppressants.
• Voluntary signing of the informed consent form (or by the legal representative).

You may not qualify if…

• Clinicians determine that the pulmonary lesion is not caused by IFD (e.g., bacterial pneumonia, tumor infiltration, etc.).
• The patient or his legal representative withdraws the informed consent.
• Due to severe underlying diseases, mental disorders, etc., the individual has lost the capacity for autonomous signing and lacks a suitable legal representative.

Full record on ClinicalTrials.gov

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