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A retrospective study on the impact of metagenomic next-generation sequencing (mNGS) of pathogenic microorganisms on the diagnosis of infectious diseases and clinical prognosis in immunosuppressed patients with hematologic diseases

A retrospective study on the impact of metagenomic next-generation sequencing (mNGS) of pathogenic microorganisms on the diagnosis of infectious diseases and clinical prognosis in immunosuppressed patients with hematologic diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116909
Enrollment
Unknown
Registered
2026-01-16
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunosuppression related to hematological diseases

Interventions

NSG Group(Submit for mNGS testing):None
Control group (not sent for mNGS testing, only traditional testing):None

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: NGS Group: 1. Diagnosed with hematologic diseases (such as leukemia, lymphoma, multiple myeloma, etc.) accompanied by immunosuppression (due to the disease or its treatment) during the period from January 1, 2015, to June 30, 2025; 2. Clinically diagnosed with a suspected or confirmed infectious disease; 3. Submitted samples for pathogen metagenomic (mNGS) testing during the course of infection diagnosis and treatment. Control Group: 1.Diagnosed with hematologic diseases accompanied by immunosuppression during the same period; 2.Clinically diagnosed with a suspected or confirmed infectious disease; 3. Did not undergo mNGS testing, with pathogen detection conducted only using traditional microbiological methods.

Exclusion criteria

Exclusion criteria: 1.Clinical data are severely missing, making it impossible to evaluate efficacy or safety; 2. In this infection event, the mNGS was submitted more than 72 hours after the initial adjustment of anti-infective treatment (aiming to analyze the impact of mNGS on decision-making); 3. Patients who were discharged or died within 48 hours after submitting specimens for mNGS or conventional testing (unable to observe the intervention effect); 4.Patients who voluntarily abandoned treatment or were discharged.

Design outcomes

Primary

MeasureTime frame
30-day all-cause mortality;Etiological diagnostic efficacy (including overall detection rate, mixed infection detection rate, and testing turnaround time);The effective rate of infectious disease treatment;

Secondary

MeasureTime frame
Initial treatment effective rate;Optimization of treatment decisions;The mortality rate related to this infection;90-day all-cause mortality;Consumption of medical resources;

Countries

China

Contacts

Public ContactLi Jie

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

157512890@qq.com+86 27 84392371

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026