UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Expression of galectin-9 and other biomarker cytokine in the immuno stimulated state
Title of the study (Brief title)	Expression of galectin-9 and other biomarker cytokine in the immuno stimulated state
Region	Japan

Condition
Condition	Tuberculosis Latent tuberculosis
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In latent tuberculosis and active tuberculosis patients, we identifies the Gal-9 and its receptor Tim3 expressing cells by multiple staining.with antibodies to various cell membrane antigen.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	By studying the kinetics of galectin-9 as a biomarker, the immunoregulatory function of galectin-9 reveals.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	1 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Letent tuberculosis 30, active tuberculosis 30 amd healthy volumteer who obteined a consent to this test
Key exclusion criteria	the person who dose not have enough judgment. the person who is unconscious. the person who need the attention for disease notification.
Target sample size	90

Research contact person
Name of lead principal investigator	Httroi Toshio
Organization	Tohoku University
Division name	International Research Institute of Disaster Science
Address	1-1 Seiryo-cho, Aoba-ku, Sendai
TEL	022-717-8220
Email	toshatto@med.tohoku.ac.jp

Public contact
Name of contact person	Yugo Ashino
Organization	Tohoku University
Division name	Division of Emerging Infectious Diseases, Graduate School of Medicine
Address	1-1 Seiryo-cho, Aoba-ku, Sendai
TEL	022-717-8220
Homepage URL
Email	ya82@rid.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	endowment
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 05 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 28 Day
Anticipated trial start date	2013 Year 10 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	summarizing data

Management information
Registered date	2015 Year 05 Month 08 Day
Last modified on	2016 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020151