Application of GeneXpert on Bronchoscopic Samples in the... | NCT02619240

Studies
Application of GeneXpert on Bronchoscopic Samples in the Clinical Management of Patients Suspicious of TB

NCT02619240

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

Apr 17, 2019Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Tuberculosis

Interventions

bronchoscopy

Countries

Hong Kong

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

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Apr 30, 2017Actual

Completion Date

Aug 30, 2017Actual

First Submitted Date

Nov 23, 2015

First Submission Date that Met QC Criteria

Nov 30, 2015

First Posted Date

Dec 2, 2015Estimated

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

Apr 16, 2019

Last Update Posted Date

Apr 17, 2019Actual

Description Module

Brief Summary

This is a case control observational study using Bronchial-alveolar lavage (BAL) as specimen for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation procedures, will be recruited for this study over a period of 18 months. Clinical likelihood of TB will be systematically scored according to various clinical parameters. This will determine the pre-test probability. Clinician will decide if anti-TB treatment is to be started and patients will be followed up for a minimal of 18 months. Sensitivity, specificity, positive, negative predictive values and the respective likelihood ratio will be calculated accordingly.

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

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients suspected of TB		patients suspected of TB requiring to undergo bronchoscopy as part of the investigation	Procedure: bronchoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bronchoscopy	Procedure	performance of bronchoscopy with BAL	patients suspected of TB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of true positive BAL PCR using GeneXpert on BAL for rapid diagnosis of TB in few hours compare to the conventional TB PCR which usually take up few days to perform		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients > 18 years old suspected of TB clinically.
Patients suspected of TB but both smear microscopy and TB PCR of sputum are negative or sputum cannot be produced.
BAL samples obtained following standard investigation procedure
CXR or CT imaging available.

Exclusion Criteria:

Bronchoscopy is not planned as a necessary procedure for investigation.
Diagnosis of active TB has been made by other means.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

adult patients with abnormal chest imaging suspected of TB as a differential diagnosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kin Wang To, MBChB	Honoary clinical assistant professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK		Shatin			Hong Kong

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001999	Bronchoscopy

Ancestor Terms

ID	Term
D003948	Diagnostic Techniques, Respiratory System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy

Browse Leaves

Not provided

Browse Branches

Not provided