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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000045715
Receipt No. R000052187
Scientific Title Diagnostic accuracy of IGRA in HIV patients
Date of disclosure of the study information 2021/10/11
Last modified on 2021/10/11

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Basic information
Public title Diagnostic accuracy of IGRA in HIV patients
Acronym Diagnostic accuracy of IGRA in HIV patients
Scientific Title Diagnostic accuracy of IGRA in HIV patients
Scientific Title:Acronym Diagnostic accuracy of IGRA in HIV patients
Region
Japan Asia(except Japan)

Condition
Condition TB
Classification by specialty
Medicine in general Infectious disease Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Test accuracy of IGRA in HIV patients
Basic objectives2 Others
Basic objectives -Others TB patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sensitivity
Key secondary outcomes Specificity

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with TB infection suspect
Key exclusion criteria Patients without information on sensitivity or specificity
Target sample size

Research contact person
Name of lead principal investigator
1st name Hao
Middle name
Last name Chen
Organization Teikyo university hospital
Division name Internal medicine
Zip code 173-8606
Address Teikyo University Hospital, 2-11-1 Kaga, Itahashi, Tokyo
TEL 03-3964-1211
Email chinsmd@gmail.com

Public contact
Name of contact person
1st name Hao
Middle name
Last name Chen
Organization Teikyo University Hospital
Division name Internal medicine
Zip code 173-8606
Address Teikyo University Hospital, 2-11-1 Kaga, Itahashi, Tokyo
TEL 03-3964-1211
Homepage URL
Email chinsmd@gmail.com

Sponsor
Institute Teikyo University Hospital
Institute
Department

Funding Source
Organization Teikyo University Hospital
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 not available
Address not available
Tel not available
Email not available

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
2021 Year 10 Month 11 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 Open public recruiting
Date of protocol fixation
2021 Year 10 Month 10 Day
Date of IRB
2021 Year 10 Month 11 Day
Anticipated trial start date
2021 Year 10 Month 11 Day
Last follow-up date
2021 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1 Department of Internal medicine, Teikyo University Graduate School of Medicine, Tokyo, Japan
2 Department of Respiratory, Kobe City Medical Center General Hospital, Kobe, Japan
3 Department of Respiratory, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan
4 Department of Respiratory, Niigata Prefectural Shibata Hospital, Niigata, Japan
5 Department of Emergency Medicine, Kawasaki Medical School Hospital, Japan
6 Department of Pulmonology, Yokohama City University Graduate School of Medicine, Yokohama,

Management information
Registered date
2021 Year 10 Month 11 Day
Last modified on
2021 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052187

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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