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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025976
Receipt No. R000029861
Scientific Title The comparison of QFT-Plus and T-Spot.TB for the diagnosis of tuberculosis infection in the renal transplant patients.
Date of disclosure of the study information 2017/02/02
Last modified on 2019/03/01

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Basic information
Public title The comparison of QFT-Plus and T-Spot.TB for the diagnosis of tuberculosis infection in the renal transplant patients.
Acronym The comparison of QFT-Plus and T-Spot.TB for the diagnosis of tuberculosis infection in the renal transplant patients.
Scientific Title The comparison of QFT-Plus and T-Spot.TB for the diagnosis of tuberculosis infection in the renal transplant patients.
Scientific Title:Acronym The comparison of QFT-Plus and T-Spot.TB for the diagnosis of tuberculosis infection in the renal transplant patients.
Region
Japan

Condition
Condition Renal transplant patients
Classification by specialty
Pneumology Nephrology Infectious disease
Surgery in general
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 the renal transplant 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 the renal transplant patients.
Key secondary outcomes To calculate the negative and indeterminant rates of QFT-Plus and T-Spot.TB in the renal transplant 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria More than 20 years old.
More than 3 months after renal transplantation.
Stable clinical course.
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
Email 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
Email tetsu.is@gmail.com

Sponsor
Institute National Hospital Organization Chiba-East-Hospital
Institute
Department

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
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 国立病院機構千葉東病院/National Hospital Organization Chiba-East-Hospital

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 02 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
2016 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 20 Day
Last follow-up date
2018 Year 08 Month 06 Day
Date of closure to data entry
2018 Year 08 Month 06 Day
Date trial data considered complete
2018 Year 08 Month 06 Day
Date analysis concluded
2018 Year 08 Month 06 Day

Other
Other related information None

Management information
Registered date
2017 Year 02 Month 02 Day
Last modified on
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029861

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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