UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018272
Receipt number R000021149
Scientific Title Sensitivity and specificity of Cobas TaqMan MTB real-time polymerase chain reaction for culture-proven Mycobacterium tuberculosis: meta-analysis
Date of disclosure of the study information 2015/07/11
Last modified on 2015/12/28 16:13:38

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Basic information

Public title

Sensitivity and specificity of Cobas TaqMan MTB real-time polymerase chain reaction for culture-proven Mycobacterium tuberculosis: meta-analysis

Acronym

Sensitivity and specificity of Cobas TaqMan MTB real-time polymerase chain reaction for culture-proven Mycobacterium tuberculosis: meta-analysis

Scientific Title

Sensitivity and specificity of Cobas TaqMan MTB real-time polymerase chain reaction for culture-proven Mycobacterium tuberculosis: meta-analysis

Scientific Title:Acronym

Sensitivity and specificity of Cobas TaqMan MTB real-time polymerase chain reaction for culture-proven Mycobacterium tuberculosis: meta-analysis

Region

Japan


Condition

Condition

Mycobacterium tuberculosis

Classification by specialty

Medicine in general Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Since 2010, studies on the diagnostic accuracy of TaqMan MTB (CTM) have been frequently reported with an unignorable discrepancy. Some previous studies suggested that these heterogeneous results may be caused by inconsistent smear status. The aim of the current systematic review and meta-analysis is to evaluate the sensitivity and specificity of CTM for culture-proven M tuberculosis with an emphasis on the impact of smear status.

Basic objectives2

Others

Basic objectives -Others

Since 2010, studies on the diagnostic accuracy of TaqMan MTB (CTM) have been frequently reported with an unignorable discrepancy. Some previous studies suggested that these heterogeneous results may be caused by inconsistent smear status. The aim of the current systematic review and meta-analysis is to evaluate the sensitivity and specificity of CTM for culture-proven M tuberculosis with an emphasis on the impact of smear status.

Trial characteristics_1

Others

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Pooled sensitiviey and pooled specificity by Cobas TaqMan MTB

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

0 years-old <=

Age-upper limit

150 years-old >

Gender

Male and Female

Key inclusion criteria

The inclusion criterion for this study was original studies that could provide sufficient data for calculating the sensitivity and/or the specificity of Cobas TaqMan MTB (CTM) for M tuberculosis or M tuberculosis complex. The reference test was Mycobacterium culture followed by TB confirmation. The composite reference standard combining the results of several reference tests was not allowed.

Key exclusion criteria

Not defined

Target sample size



Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuyuki Horita

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Pulmonology

Zip code


Address

3-9 Fukuura, Kanazawa, Yokohama

TEL

045-352-7962.

Email

horitano@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nobuyuki Horita

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Pulmonology

Zip code


Address

3-9 Fukuura, Kanazawa, Yokohama

TEL

045-352-7962.

Homepage URL


Email

horitano@yokohama-cu.ac.jp


Sponsor or person

Institute

Department of Pulmonology, Yokohama City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 11 Day


Related information

URL releasing protocol

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4673449/pdf/srep18113.pdf

Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4673449/pdf/srep18113.pdf

Number of participants that the trial has enrolled


Results

Since 2010, studies on the diagnostic accuracy of COBAS TaqMan MTB (CTM) have been frequently reported with an unignorable discrepancy. The key inclusion criterion for this systematic review was original studies that could provide sufficient data for calculating the sensitivity and the specificity of CTM for M tuberculosis (TB) or M tuberculosis complex. The reference test was Mycobacterium culture. We used bivariate model for meta-analyses. Of the 201 candidate articles, we finally identified 17 eligible articles.Concerning the respiratory specimens, 1900 culture positive specimens and 20983 culture negative specimens from 15 studies were assessed. This provided the summary estimate sensitivity of 0.808 (95%CI 0.758-0.850) and the summary estimate specificity of 0.990 (95%CI 0.981-0.994). The area under curve was 0.956. The diagnostic odds ratio was 459 (95%CI 261-805, I(2) 26%). For the smear positive respiratory specimens, the sensitivity was 0.952 (95%CI 0.926-0.969) and the specificity was 0.916 (95%CI 0.797-0.968). For the smear negative respiratory specimens, the sensitivity and the specificity were 0.600 (95%CI 0.459-0.726) and 0.989 (95%CI 0.981-0.993), respectively. The diagnostic accuracy was poorer for the non-respiratory specimens, than for the respiratory specimens, but was acceptable. We believe that the information obtained from this study will aid physicians' decision making.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2015 Year 07 Month 11 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 11 Day

Last follow-up date

2015 Year 12 Month 09 Day

Date of closure to data entry

2015 Year 12 Month 09 Day

Date trial data considered complete

2015 Year 12 Month 09 Day

Date analysis concluded

2015 Year 12 Month 09 Day


Other

Other related information

We conducted this meta-analysis following pre-specified protocol according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and standard guidelines for systematic review of diagnostic test accuracy. Quality of included studies was assessed by Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS2).18 Approval of Institutional Review Board was wavered for reviewing nature of the current study.


Management information

Registered date

2015 Year 07 Month 11 Day

Last modified on

2015 Year 12 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021149


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name