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mNGS for IFD in Patients With Hematological Malignancies

NCT07763184 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-08-13

No results posted yet for this 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.

Conditions

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-10
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT07763184 on ClinicalTrials.gov