Diagnostic Efficacy of Metagenomic Next-generation Sequen... | NCT06172153

Studies
Diagnostic Efficacy of Metagenomic Next-generation Sequencing in Patients With Spinal Infections: A Retrospective Study

NCT06172153

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Status

Unknown status

Last Update Posted

Dec 15, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Spinal Infection
Diagnositic Efficacy

Interventions

No interventions

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

May 1, 2024Estimated

Completion Date

May 1, 2024Estimated

First Submitted Date

Dec 7, 2023

First Submission Date that Met QC Criteria

Dec 14, 2023

First Posted Date

Dec 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2023

Last Update Posted Date

Dec 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Comparing the diagnostic efficacy between traditional laboratory methods and second-generation high-throughput sequencing in patients suspected of spinal infections.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sun Yat-sen memorial hospital		Patients who were suspected of Spinal infection.	Other: No interventions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No interventions	Other	No intervention	Sun Yat-sen memorial hospital

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The diagnositic efficacy	Sensitivity, Specificity	1 year
The diagnositic efficacy	Positive Predictive Value, Negative Predictive Value	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

"Patients suspected of spinal infections, as per the American Infectious Diseases Society's 2015 criteria for primary vertebral osteomyelitis, were identified based on their clinical symptoms, laboratory tests, and imaging examinations. All cases included in the study underwent laboratory examinations, histopathological examinations, and second-generation high-throughput sequencing (metagenomic sequencing)."

Exclusion Criteria:

"The absence of laboratory examinations, histopathological examinations, and results from second-generation high-throughput sequencing (metagenomic sequencing)."

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

"The patients suspected of spinal infections were admitted to the Orthopedic Department of Sun Yat-sen Memorial Hospital, Sun Yat-sen University."

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chunhai Li, MD	Contact	18602079796		lichhai@mail.sysu.edu.cn
hanwen cheng, Master	Contact	19541080926		chenghw3@mail2.sysu.edu.cn

Overall Officials

Name	Affiliation	Role
Chunhai Li, MD	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen memorial hospital	Recruiting	Guangzhou	Guangdong	510000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided