UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035253
Receipt No. 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 2018/12/14

* 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 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
Middle name
Last name Hideaki Nagai
Organization National Hospital Organization Tokyo National Hospital
Division name The director of the clinical research center
Zip code
Address 3-1-1 Takeoka, Kiyose-shi, Tokyo,204-8585, JAPAN
TEL 042-491-2111
Email hnagai-in@tokyo-hosp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Maho Suzukawa
Organization National Hospital Organization Tokyo National Hospital
Division name Clinical Research Center
Zip code
Address 3-1-1 Takeoka, Kiyose, Tokyo 204-8585
TEL 042-491-2111
Homepage URL
Email fueta-tky@umin.ac.jp

Sponsor
Institute National Hospital Organization
Institute
Department

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
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 12 Month 14 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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 30 Day
Last follow-up date
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
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040165

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.