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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029362
Receipt No. R000033557
Scientific Title Evaluation of mycobacterial disease activity by measurement of serum biomarkers
Date of disclosure of the study information 2017/10/02
Last modified on 2018/04/01

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Basic information
Public title Evaluation of mycobacterial disease activity by measurement of serum biomarkers
Acronym Evaluation of mycobacterial disease activity
Scientific Title Evaluation of mycobacterial disease activity by measurement of serum biomarkers
Scientific Title:Acronym Evaluation of mycobacterial disease activity
Region
Japan

Condition
Condition Mycobacterial disease
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine if it is possible to evaluate mycobacterial disease activity by measurement of serum biomarkers
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum biomarkers
Key secondary outcomes

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 The patients with mycobacterial diseases who consent voluntarily to participate as participants in this study.
Key exclusion criteria The patients with mycobacterial diseases who don't consent voluntarily to participate as participants in this study.
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Hasegawa
Organization Keio University
Division name School of Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5315-4287
Email n-hasegawa@z8.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Hasegawa
Organization Keio University
Division name School of Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5315-4287
Homepage URL
Email n-hasegawa@z8.keio.jp

Sponsor
Institute Keio University
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

Other related organizations
Co-sponsor Fukujuji Hospital, Japan Anti-Tuberculosis Association
Toneyama National Hospital
Kawasaki Municipal Ida Hospital
Leprosy Research Center, National Institute of Infectious Diseases
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
2017 Year 10 Month 02 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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We determine if the candidates of serum biomarkers correlate with mycobacterial disease activity estimated by clinical information.

Management information
Registered date
2017 Year 09 Month 30 Day
Last modified on
2018 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033557

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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