UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029362 |
|---|---|
| Receipt number | 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 | 2023/10/05 14:34:41 |
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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 | Naoki |
| Middle name | |
| Last name | Hasegawa |
Organization
Keio University
Division name
School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5315-4287
n-hasegawa@z8.keio.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Hasegawa |
Organization
Keio University
Division name
School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5315-4287
Homepage URL
n-hasegawa@z8.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
Institutional Ethics Review Committee, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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
| 2017 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033557
