UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021165 |
|---|---|
| Receipt number | R000024407 |
| Scientific Title | The comparison of QFT-Plus and T-Spot.TB for the diagnosis of tuberculosis infection in rheumatoid arthritis patients. |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2018/02/24 09:57:42 |
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Basic information
Public title
The comparison of QFT-Plus and T-Spot.TB for the diagnosis of tuberculosis infection in rheumatoid arthritis patients.
Acronym
The comparison of QFT-Plus and T-Spot.TB for the diagnosis of tuberculosis infection in rheumatoid arthritis patients.
Scientific Title
The comparison of QFT-Plus and T-Spot.TB for the diagnosis of tuberculosis infection in rheumatoid arthritis patients.
Scientific Title:Acronym
The comparison of QFT-Plus and T-Spot.TB for the diagnosis of tuberculosis infection in rheumatoid arthritis patients.
Region
| Japan |
Condition
Condition
Rheumatoid arthritis patients.
Classification by specialty
| Pneumology | Clinical immunology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The comparison of QFT-Plus and T-Spot.TB for the diagnosis of tuberculosis infection in rheumatoid arthritis patients.CD4 + lymphocyte and CD8+ lymphocyte count are also calculated for the analysis of the effects on immune response in QFT-Plus and T-Spot.TB.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To calculate the positive rates of QFT-Plus and T-Spot.TB in rheumatoid arthritis patients.
Key secondary outcomes
To calculate the negative and indeterminant rates of QFT-Plus and T-Spot.TB in rheumatoid arthritis patients. The negative predictive value is analyzed during observation period.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Rheumatoid patients.
All participants are given sufficient information about this study, and then written informed consents are obtained from them.
Key exclusion criteria
The patients who are judged to be inapropriate for this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Ishikawa |
Organization
National Hospital Organization Chiba-East-Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
673 Nitona-cho, Chuo-ku, Chiba-shi, Chiba 260-8712, Japan
TEL
+81-43-261-5171
tetsu.is@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Ishikawa |
Organization
National Hospital Organization Chiba-East-Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
673 Nitona-cho, Chuo-ku, Chiba-shi, Chiba 260-8712, Japan
TEL
+81-43-261-5171
Homepage URL
http://www.chiba-easthp.jp/introduction/rinsyou
tetsu.is@gmail.com
Sponsor or person
Institute
National Hospital Organization Chiba-East-Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Chiba University Hospital
Name of secondary funder(s)
Chiba Foundation for Health Promotion and Disease Prevention
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
National Hospital Organization Chiba-East-Hospital
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 01 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 01 | Day |
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 02 | Month | 23 | Day |
Last modified on
| 2018 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024407
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
