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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033731
Receipt No. R000037939
Scientific Title Analysis of human receptors using with peripheral blood from patients of pulmonary tuberculosis, latent TB infection, past TB infection or non-tuberculous mycobacteria infection
Date of disclosure of the study information 2018/10/01
Last modified on 2018/07/05

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Basic information
Public title Analysis of human receptors using with peripheral blood from patients of pulmonary tuberculosis, latent TB infection, past TB infection or non-tuberculous mycobacteria infection
Acronym Analysis of human receptors using with peripheral blood
Scientific Title Analysis of human receptors using with peripheral blood from patients of pulmonary tuberculosis, latent TB infection, past TB infection or non-tuberculous mycobacteria infection
Scientific Title:Acronym Analysis of human receptors using with peripheral blood
Region
Japan

Condition
Condition pulmonary active TB, latent TB, old TB or non-tuberculous mycobacteriosis
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Expression analysis of human receptors to evaluate the extent of mycobacterial diseases
Basic objectives2 Others
Basic objectives -Others Expression of human receptors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Expression percentage and/or pattern of host receptors
Key secondary outcomes

Base
Study type Observational

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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients with active TB, latent TB, old TB or non tuberculous mycobacteria
Key exclusion criteria Patients who do not agree with informed consent documents
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Hoshino
Organization National Institute of Infectious Diseases
Division name Mycobacteriology
Zip code
Address 4-2-1 Aoba Higashi-Murayama TOKYO
TEL 042-391-8211
Email hoshino-niid@umin.org

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiko Hoshino
Organization National Institute of Infectious Diseases
Division name Mycobacteriology
Zip code
Address 4-2-1 Aoba Higashi-Murayama TOKYO
TEL 042-391-8211
Homepage URL
Email hoshino-niid@umin.org

Sponsor
Institute National Institute of Infectious Diseases
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development/Japan International Cooperation Agency (AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Japan Anti-Tuberculosis Association Fukujuji Hospital
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
2018 Year 10 Month 01 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
2018 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Analysis of expression of host blood receptors

Management information
Registered date
2018 Year 08 Month 13 Day
Last modified on
2018 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037939

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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