UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033731
Receipt number 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 18:14:52

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

National Institute of Infectious Diseases

Institute

Department

Personal name



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

Value
https://center6.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