UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035253 |
|---|---|
| Receipt number | R000040165 |
| Scientific Title | Evaluation of QFT TB Gold Plus for Mycobacterium tuberculosis infection |
| Date of disclosure of the study information | 2018/12/14 |
| Last modified on | 2022/03/30 11:02:39 |
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Basic information
Public title
Evaluation of QFT TB Gold Plus for Mycobacterium tuberculosis infection
Acronym
Evaluation of QFT Plus
Scientific Title
Evaluation of QFT TB Gold Plus for Mycobacterium tuberculosis infection
Scientific Title:Acronym
Evaluation of QFT Plus
Region
| Japan |
Condition
Condition
active tuberculosis patients, LTBI patients, previous tuberculosis patients, healthy donors
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate QFT-Plus for Mycobacterium tuberculosis infection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sensitivity and specificity of QFT-Plus for diagnosing active tuberculosis patients
Key secondary outcomes
Sensitivity and specificity of QFT-Plus for immunocompromised active tuberculosis patients.
Comparison of cytokine levels among supernatants of antigens in QFT-Plus and QFT-GIT.
Monitoring QFT-Plus during treatment or follow up for active tuberculosis and LTBI patients.
Evaluation of QFT-plus for previous tuberculosis patients.
Discrimination between active tuberculosis and LTBI patient using cytokines in supernatants of QFT-Plus and QFT-GIT.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Active tuberculosis patients
1) Culture positive results.
2) Positive result of smear or nucleic acid amplification method in case of no culture result when the patients is enrolled.
LTBI patients
1) No symptoms, physical findings and laboratory results consistent with tuberculosis.
2) Positive results for QFT-GIT.
3) No medical history of tuberculosis.
4) Negative result of smear and culture test for tuberculosis.
Previous tuberculosis patients
1) No symptoms, physical findings and laboratory results consistent with tuberculosis.
2) Patients had history of tuberculosis.
3) Negative result of smear and culture test for tuberculosis.
Healthy donor
1) No symptoms, physical findings and laboratory results consistent with tuberculosis.
2) Negative results for QFT-GIT.
3) No medical history of tuberculosis.
4) Negative result of smear and culture test for tuberculosis.
Key exclusion criteria
All subjects
1. patients aged under 18 years old.
2. treatment tuberculosis including fluoroquinolone for longer than 2 weeks.
3. Patients for whom the investigator decided not suitable for participation in this study.
Active tuberculosis patients
A negative result on culture test.
LTBI patients
Patients had history of tuberculosis.
Healthy donor
Subjects had history of tuberculosis.
Subjects had history of contact to active tuberculosis patients.
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Nagai |
Organization
National Hospital Organization Tokyo National Hospital
Division name
The director of the clinical research center
Zip code
204-8585
Address
3-1-1 Takeoka, Kiyose-shi, Tokyo,204-8585, JAPAN
TEL
042-491-2111
hnagai-in@tokyo-hosp.jp
Public contact
Name of contact person
| 1st name | Maho |
| Middle name | |
| Last name | Suzukawa |
Organization
National Hospital Organization Tokyo National Hospital
Division name
Clinical Research Center
Zip code
204-8585
Address
3-1-1 Takeoka, Kiyose, Tokyo 204-8585
TEL
042-491-2111
Homepage URL
fueta-tky@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
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
National Hospital Organization Tokyo National Hospital
Address
3-1-1 Takeoka, Kiyose-Shi, Tokyo 204-8585, Japan
Tel
042-491-2111
goto.yumiko.zj@mail.hosp.go.jp
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 | 12 | Month | 14 | Day |
Related information
URL releasing protocol
https://www.journalofinfection.com/article/S0163-4453(20)30092-X/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.journalofinfection.com/article/S0163-4453(20)30092-X/fulltext
Number of participants that the trial has enrolled
153
Results
Some cytokines were higher in the 3G Ag tube compared to both the TB1 and TB2 tubes. TB2 showed greater production of only PDGF-BB than TB1. For diagnosing active tuberculosis, the levels of IP-10 were superior to the level of IFN-g based on showing a larger AUC for ROC curves in our present study setting. The levels of IFN-g, IL-1RA, IL-2, IP-10, MCP-1 and MIP-1b were different between the active tuberculosis patients and healthy controls.
Results date posted
| 2022 | Year | 03 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
active tuberculosis patients and healthy control subjects
Participant flow
QFT-3G and QFT-plus were performed. At the same time, blood cell culture supernatants were collected and assayed for their cytokine levels using Luminex Assay and MAGPIX System.
Adverse events
none
Outcome measures
The levels of cytokines were compared between different antigen-containing tubes (3G Ag, TB1 and TB2 tubes), as well as between the patients and the control subjects. ROC curves were drawn, and the AUCs were calculated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not applicable
Management information
Registered date
| 2018 | Year | 12 | Month | 14 | Day |
Last modified on
| 2022 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040165
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| Registered date | File name |
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