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
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
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
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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/7507
