Blood mNGS for Diagnosing Invasive Pulmonary Fungal Disease in Hematologic Patients

NCT07511595 | Not Yet Recruiting

• 1 other identifier: PKUPH20260120
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Diagnostic power of metagenomic next-generation sequencing (mNGS) for invasive pulmonary fungal infections in hematological patients

  The diagnostic performance of blood metagenomic next-generation sequencing (mNGS) for invasive pulmonary fungal disease (IFD), assessed by: Sensitivity Specificity Positive predictive value (PPV) Negative predictive value (NPV) Accuracy All diagnostic parameters will be evaluated at 42 days after enrollment, using the EORTC/MSG 2020 consensus definitions for IFD (proven, probable, possible, or no IFD) as the reference standard.

  42days from enrollment

Study Arms (1)

Study Cohort

All eligible patients with hematologic diseases suspected of having invasive pulmonary fungal disease will be enrolled in this single cohort.

Other: Blood microbial metagenomic next-generation sequencing (mNGS)

Interventions

Blood microbial metagenomic next-generation sequencing (mNGS) OTHER

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

Study Cohort

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective, multicenter diagnostic study enrolling patients (≥14 years) with underlying hematologic diseases who are clinically suspected of having invasive pulmonary fungal disease.

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.

Sponsors & Collaborators

• Peking University First Hospital: collaborator
• Hebei Yanda Ludaopei Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Shandong Provincial Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• KingMed Diagnostics: collaborator
• Peking University People's Hospital: lead

Central Study Contacts

RUI MA

CONTACT

8613041076278; marui_pku_ed@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04