UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006338
Receipt number R000007507
Scientific Title Development of new diagnostic methods of tuberculosis infection using Mycobacterium tuberculosis specific antigens.
Date of disclosure of the study information 2011/10/20
Last modified on 2018/03/01 09:57:18

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Basic information

Public title

Development of new diagnostic methods of tuberculosis infection using Mycobacterium tuberculosis specific antigens.

Acronym

Development of new diagnostic methods of TB infection

Scientific Title

Development of new diagnostic methods of tuberculosis infection using Mycobacterium tuberculosis specific antigens.

Scientific Title:Acronym

Development of new diagnostic methods of TB infection

Region

Japan


Condition

Condition

Tuberculosis infection

Classification by specialty

Pneumology Infectious disease Adult
Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To develop the diagnostic methods of tuberculosis infection which had high sensitivity and specificity by measuring the various cytokines and chemokines using clinical specimens such as peripheral blood or cavity fluid1

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1 IFN-gamma
2 TNF-alfa
3 IL-2
4 IP-10
5 MCP-2
detected from the peripheral blood or cavity fluid after the response with M. tuberculosis specific antigens

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Diagnosis

Type of intervention

Medicine Device,equipment

Interventions/Control_1

Definite group of tuberculosis infection (Isolation of Mycobacterium tuberculosis from the clinical specimens)

Interventions/Control_2

Suspicious group of tuberculosis infection (No isolation of Mycobacterium tuberculosis from the clinical specimens, but antituberculous treatment was effective)

Interventions/Control_3

Other disease group

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

15 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1 Outpatients or inpatients with suspicious of tuberculosis infection (pulmonary tuberculisis, tuberculous pleuritis, tuberculous peritonitis) in our hospital
2 Patients obtained the informed consent of this study

Key exclusion criteria

1 Patients not obatined the informed consent of this study
2 Patients who physical doctors judged the appropriation for the inclusion of this study

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihiro Kobashi

Organization

Kawasaki Medical School Hospital

Division name

Division of Respiratory Diseases, Department of Medicine

Zip code


Address

577, Matsushima, Kurashiki city

TEL

086-462-1111

Email

yoshihiro@med.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshihiro Kobashi

Organization

Kawasaki Medical School Hospital

Division name

Division of Respiratory Diseases, Department of Medicine

Zip code


Address

577, Matsushima, Kurashiki city

TEL

086-462-1111

Homepage URL


Email

yoshihiro@med.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki Medical School Hospital

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical Schoool

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

2011 Year 10 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2011 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 10 Month 01 Day

Last follow-up date

2018 Year 03 Month 19 Day

Date of closure to data entry

2018 Year 03 Month 19 Day

Date trial data considered complete

2018 Year 03 Month 19 Day

Date analysis concluded

2018 Year 04 Month 10 Day


Other

Other related information



Management information

Registered date

2011 Year 09 Month 13 Day

Last modified on

2018 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007507


Research Plan
Registered date File name
2017/02/10 研究実施計画書.doc

Research case data specifications
Registered date File name
2018/02/28 結核感染診断研究症例データ仕様書(UMIN用)、その3.pptx

Research case data
Registered date File name
2018/03/01 活動性結核と陳旧性結核、潜在性結核の鑑別(UMIN登録用).xlsx