UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041434 |
|---|---|
| Receipt number | R000047203 |
| Scientific Title | Diagnostic accuracy of chest X-ray, CT, and interferon-gamma release assay to detect the miliary tuberculosis: systematic review and meta-analysis |
| Date of disclosure of the study information | 2020/08/18 |
| Last modified on | 2020/08/17 07:02:31 |
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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
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
me19003@s.okayama-u.ac.jp
Sponsor or person
Institute
Yokohama Municipal Citizen's Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047203
