UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030736 |
|---|---|
| Receipt number | R000024115 |
| Scientific Title | Efficacy of detection of urine Mycobacterium tuberculosis bacilli gene by polymerase chain reaction techniques on diagnosis of miliary tuberculosis |
| Date of disclosure of the study information | 2018/01/09 |
| Last modified on | 2018/01/09 17:46:47 |
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Basic information
Public title
Efficacy of detection of urine Mycobacterium tuberculosis bacilli gene by polymerase chain reaction techniques on diagnosis of miliary tuberculosis
Acronym
Efficacy of urine TB gene by PCR techniques on diagnosis of MTB
Scientific Title
Efficacy of detection of urine Mycobacterium tuberculosis bacilli gene by polymerase chain reaction techniques on diagnosis of miliary tuberculosis
Scientific Title:Acronym
Efficacy of urine TB gene by PCR techniques on diagnosis of MTB
Region
| Japan |
Condition
Condition
Miliary tuberculosis and disseminated pulmonary tuberculosis
Classification by specialty
| Pneumology | Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Efficacy of detection of urine TB gene by PCR on diagnosis of MTB
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate sensitivity, specificity, positive predictive value and negative predictive value of detection of urine TB gene by PCR on diagnosis of MTB
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
1. Inpatients with tuberculosis infections hospitalized at Kurume University School of Medicine between April 1st, 1997 and March 31st, 2009.
2. Age>and=20yrs
3. Findings of diffuse disseminated pulmonary nodules pattern (TB classification bIII3)
4. Histories of detection of TB antigen in sputum and urine by culture and PCR before anti-tuberculosis therapy
Key exclusion criteria
none
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomotaka Kawayama |
Organization
Kurume University
Division name
Department of medicine
Zip code
Address
67 Asahimachi, Kurume
TEL
0942-35-3311
kawayama_tomotaka@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomotaka Kawayama |
Organization
Kurume University
Division name
Department of medicine
Zip code
Address
67 Asahimachi, Kurume
TEL
0942-35-3311
Homepage URL
kawayama_tomotaka@med.kurume-u.ac.jp
Sponsor or person
Institute
Department of medicine, Kurume University
Institute
Department
Personal name
Funding Source
Organization
Department of medicine, Kurume University
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 01 | Month | 09 | 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 | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2018 | Year | 01 | Month | 09 | Day |
Last modified on
| 2018 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024115
