UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016454 |
|---|---|
| Receipt number | R000019107 |
| Scientific Title | Observational study of the usefulness of an iron metabolism-related molecule hepcidin as a therapeutic response biomarker in Mycobacterium tuberculosis patients. |
| Date of disclosure of the study information | 2015/02/05 |
| Last modified on | 2018/02/08 15:30:44 |
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Basic information
Public title
Observational study of the usefulness of an iron metabolism-related molecule hepcidin as a therapeutic response biomarker in Mycobacterium tuberculosis patients.
Acronym
Observational study of the usefulness of an iron metabolism-related molecule hepcidin as a therapeutic response biomarker in Mycobacterium tuberculosis patients.
Scientific Title
Observational study of the usefulness of an iron metabolism-related molecule hepcidin as a therapeutic response biomarker in Mycobacterium tuberculosis patients.
Scientific Title:Acronym
Observational study of the usefulness of an iron metabolism-related molecule hepcidin as a therapeutic response biomarker in Mycobacterium tuberculosis patients.
Region
| Japan |
Condition
Condition
Mycobacterium tuberculosis infection
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the effect of hepcidin level on the efficacy of anti-tuberculosis chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Relation between period required for improvement in clinical symptoms or bacteriological examinations and hepcidin level.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Blood sampling for hepcidin level measurement at clinical routine sampling.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals with Mycobacterium tuberculosis infection who have capability of informed consent
Key exclusion criteria
Individuals without capability of informed consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Yamamoto |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Respirology
Zip code
Address
3-9 Fukuura,Kanazawa-ku, Yokohama, 236-0004, Japan
TEL
045-787-2630
masakiy@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Yamamoto |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Respirology
Zip code
Address
3-9 Fukuura,Kanazawa-ku, Yokohama, 236-0004, Japan
TEL
045-787-2630
Homepage URL
masakiy@yokohama-cu.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Yokohama City University, Department of Respirology
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Yokohama City University, Department of Respirology
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
| 2015 | Year | 02 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 05 | Day |
Last modified on
| 2018 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019107
