UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of detection of urine Mycobacterium tuberculosis bacilli gene by polymerase chain reaction techniques on diagnosis of miliary tuberculosis
Title of the study (Brief title)	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	Tomotaka Kawayama
Organization	Kurume University
Division name	Department of medicine
Address	67 Asahimachi, Kurume
TEL	0942-35-3311
Email	kawayama_tomotaka@med.kurume-u.ac.jp

Public contact
Name of contact person	Tomotaka Kawayama
Organization	Kurume University
Division name	Department of medicine
Address	67 Asahimachi, Kurume
TEL	0942-35-3311
Homepage URL
Email	kawayama_tomotaka@med.kurume-u.ac.jp

Sponsor
Institute	Department of medicine, Kurume University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024115