mNGS for IFD in Patients With Hematological Malignancies

NCT07763184 · tracked via the Priya Life Science China tracker

Sponsor

Nanfang Hospital, Southern Medical University

Phase

Observational

Started

2026-08-10

Last updated

2026-08-13

Condition(s) studied

Hematological MalignanciesInvasive Fungal Disease

Investigational drug(s) / intervention(s)

metagenomic next-generation sequencing

metagenomic next-generation sequencing: The peripheral blood of the anticipants will be collected and sent to Tianjin Concord Bojing Medical Diagnostic Technology Co., Ltd. for mNGS testing.

Study summary

Invasive fungal disease (IFD) refers to an infectious disease caused by fungi invading the human body, growing and reproducing in tissues, organs, or blood, and leading to inflammatory responses and tissue damage. Due to the suppression of immune system function during the disease and its treatment process, patients with hematological malignancies are prone to opportunistic infections, including IFD, with the lungs being the most common site of infection. In patients with hematological malignancies, IFD is often difficult to diagnose and progresses rapidly. Some patients become critically ill, which severely affects their prognosis. With the rapid development of molecular biology techniques, metagenomic next-generation sequencing (mNGS) of pathogenic microorganisms-as a broad-coverage, highly sensitive diagnostic tool with a short reporting cycle-has been widely applied in the etiological diagnosis of clinical infectious diseases. However, its clinical value in the diagnosis of IFD remains to be explored. This study is a single-center, single-arm, open-label clinical study to to explore the clinical performance of peripheral blood mNGS in the diagnosis and treatment of IFD in patients with hematological malignancies.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * Voluntarily signed the Informed Consent Form (ICF); * Diagnosed with a hematological malignancy and receiving necessary treatment according to clinical medical orders; * Presenting with clinical symptoms, signs, or imaging features suspected of IFD. Clinical symptoms or signs include fever, cough, expectoration, chest pain, skin and soft tissue infectious lesions, or symptoms related to other deep tissue involvement. Imaging features vary depending on the site of infection, including: if involving the lower respiratory tract/lungs, a CT scan showing at least the presence of dense, well-defined lesions (with or without a halo sign), air crescent sign, cavity, wedge-shaped/segmental or lobar consolidations, reversed halo sign, etc.; if involving the central nervous system (CNS), an MRI/CT scan indicating meningeal enhancement; or corresponding imaging features for the involvement of other deep tissues. Exclusion Criteria: * Unable to undergo necessary conventional microbiological testing or imaging examinations; * Deemed unsuitable to participate in this study by the investigator.

Primary outcome measure(s)

The sensitivity and specificity of peripheral blood mNGS in diagnosing IFD — up to 14 days

Trial sites (1)

Facility	City	Region	Status
Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07763184 on ClinicalTrials.gov ↗ ← All trials in China