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Clinical evaluation of metagenomic next generation sequencing test for the diagnosis of oral ulcer infection in patients with hematological diseases

Clinical evaluation of metagenomic next generation sequencing test for the diagnosis of oral ulcer infection in patients with hematological diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100052599
Enrollment
Unknown
Registered
2021-11-02
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Hematological diseases

Interventions

Gold Standard:Histopathological examination of oral ulcer tissue and blood culture
Clinical refernce standards of oral mucositis: WHO scale standard.
Index test:Metagenomic&#32
next&#32
generation&#32
sequencing&#32
test.

Sponsors

Hematology Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. Patients had been diagnosed with blood diseases; 3. Patients had fever accompanied by oral ulcers.

Exclusion criteria

Exclusion criteria: 1. Inability to obtain sufficient sample or unsatisfactory sample quality; 2. HIV patient; 3. The patient with severe periodontal disease; 4. Pregnant woman.

Design outcomes

Primary

MeasureTime frame
scale of oral mucositis;oral swab culture;blood culture;metagenomic next generation sequencing test;sensitivity, specificity, accuracy;—

Countries

China

Contacts

Public ContactXu Chunhui

Hematology Hospital, Chinese Academy of Medical Sciences

xuchunhui@ihcams.ac.cn+86 15822592002

Outcome results

None listed

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