UMIN-CTR Clinical Trial

Basic information
Public title	Diagnostic accuracy of chest X-ray, CT, and interferon-gamma release assay to detect the miliary tuberculosis: systematic review and meta-analysis
Acronym	Diagnostic accuracy of chest X-ray, CT, and interferon-gamma release assay to detect the miliary tuberculosis: systematic review and meta-analysis
Scientific Title	Diagnostic accuracy of chest X-ray, CT, and interferon-gamma release assay to detect the miliary tuberculosis: systematic review and meta-analysis
Scientific Title:Acronym	Diagnostic accuracy of chest X-ray, CT, and interferon-gamma release assay to detect the miliary tuberculosis: systematic review and meta-analysis
Region	Japan

Condition
Condition	Milliary tuberculosis
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Identify the diagnostic accuracy of chest X-ray, CT, and interferon-gamma release assay to detect the miliary tuberculosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	True positives, false positives, true negatives, and false negatives.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients suspected of miliary tuberculosis infection
Key exclusion criteria	None
Target sample size	0

Research contact person
Name of lead principal investigator	1st name Masaharu Middle name Last name Aga
Organization	Yokohama Municipal Citizen's Hospital
Division name	Department of Respiratory Medicine
Zip code	221-0855
Address	1-1 Mitsuzawa Nishimachi Kanagawa-ku, Yokohama-shi, Kanagawa, Japan
TEL	045-316-4580
Email	me19003@s.okayama-u.ac.jp

Public contact
Name of contact person	1st name Masaharu Middle name Last name Aga
Organization	Yokohama Municipal Citizen's Hospital
Division name	Department of Respiratory Medicine
Zip code	221-0855
Address	1-1 Mitsuzawa Nishimachi Kanagawa-ku, Yokohama-shi, Kanagawa, Japan
TEL	045-316-4580
Homepage URL
Email	me19003@s.okayama-u.ac.jp

Sponsor
Institute	Yokohama Municipal Citizen's Hospital
Institute
Department

Funding Source
Organization	Self funding
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	Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital
Address	1-1 Mitsuzawa Nishimachi Kanagawa-ku, Yokohama-shi, Kanagawa, Japan
Tel	045-316-4580
Email	me19003@s.okayama-u.ac.jp

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	2020 Year 08 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	Preinitiation
Date of protocol fixation	2020 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date	2020 Year 08 Month 18 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Participants The target participants are suspected of miliary tuberculosis. Target condition The target condition is miliary tuberculosis. Setting Any type of settings is included. Index test The index test being investigated is chest X-ray, CT, and interferon-gamma release assay. Reference standard The reference standard is the identification of Mycobacterium tuberculosis by anti-acid culture or PCR of blood, urine, lower respiratory tract samples, and other tissues.

Management information
Registered date	2020 Year 08 Month 17 Day
Last modified on	2020 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047203