Rapid and Accurate Detection of Major Mycobacterium Speci... | NCT04345939

Studies
Rapid and Accurate Detection of Major Mycobacterium Species in Pulmonary Infection Based on GenSeizer Platform

NCT04345939

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Status

Unknown status

Last Update Posted

Oct 6, 2021Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Mycobacterium Pulmonary Infection

Interventions

Detection method

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

Sep 2021

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 28, 2021Actual

Primary Completion Date

Aug 30, 2024Estimated

Completion Date

Aug 30, 2024Estimated

First Submitted Date

Apr 10, 2020

First Submission Date that Met QC Criteria

Apr 13, 2020

First Posted Date

Apr 15, 2020Actual

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

Sep 29, 2021

Last Update Posted Date

Oct 6, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Haiqng Chu, Director, Shanghai Pulmonary Hospital, Shanghai, ChinaPrincipal Investigator

Lead Sponsor

Shanghai Pulmonary Hospital, Shanghai, ChinaOTHER

Collaborators

Not provided

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

Comparison of rapid detection methods of mycobacterial pathogens, GenSeizer v.s. PCR reverse hybridization.

Detailed Description

The investigators developed a new platform called GenSeizer, which combines bioinformatics analysis of a large dataset with multiplex PCR-based targeted gene sequencing, to identify eleven major Mycobacterium species implicated in human disease. Simultaneous detection of certain antibiotic resistance genotypes, i.e., erm(41) and rrl in M. abscessus, is also feasible. This platform detected both reference strains and clinical isolates with a high degree of specificity and sensitivity.

In this study, the investigators plan to verify the detection efficiency of GenSeizer in clinical samples (sputum, alveolar lavage fluid) and compare it with existing methods on the market (PCR reverse hybridization) and gold standard method (target sequencing after incubation)

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

400Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
GenSeizer	Sputum and lavage fluids are tested for pathogens using GenSeizer	Diagnostic Test: Detection method
PCR reverse hybridization	Sputum and lavage fluids are tested for pathogens using PCR reverse hybridization	Diagnostic Test: Detection method
Target sequencing after incubation	Sputum and lavage fluids are tested for pathogens using Target sequencing after incubation	Diagnostic Test: Detection method

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Detection method	Diagnostic Test	Different methods for pathogen diagnosis	GenSeizer PCR reverse hybridization Target sequencing after incubation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection accuracy		through study completion, an average of 3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suspected cases of mycobacterial lung infection

Exclusion Criteria:

No sputum
Refused or unable to tolerate bronchoscopy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Suspected cases of mycobacterial lung infection

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haiqing Chu	Recruiting	Shanghai			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

Intervention Browse Module

MeSH Terms

ID	Term
D010061	Ovulation Detection

Ancestor Terms

ID	Term
D010050	Ovarian Function Tests
D003944	Diagnostic Techniques, Obstetrical and Gynecological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

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Browse Branches

Not provided