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NCT Number: NCT07763184

mNGS for IFD in Patients With Hematological Malignancies

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.

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Key information

Conditions

Hematological Malignancies Bacterial Infections and Mycoses Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Infections Invasive Fungal Disease Invasive Fungal Infections Mycoses Neoplasms Neoplasms by Site

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metagenomic next-generation sequencing

Diagnostic Test

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

Primary outcomes

  1. The sensitivity and specificity of peripheral blood mNGS in diagnosing IFD

    Time frame: up to 14 days

Study contacts

Contact information is provided by the study sponsor or research team.

Ren Lin

CONTACT

[email protected]

+86-20-61641615

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

Application of Peripheral Blood Pathogen Metagenomic Next-Generation Sequencing in the Diagnosis of Invasive Fungal Disease in Patients With Hematological Malignancies

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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