UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013550 |
|---|---|
| Receipt number | R000015832 |
| Scientific Title | Metagenome analysis of normal middle ear cavity |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2018/02/10 09:09:21 |
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Basic information
Public title
Metagenome analysis of normal middle ear cavity
Acronym
Metagenome analysis of normal middle ear cavity
Scientific Title
Metagenome analysis of normal middle ear cavity
Scientific Title:Acronym
Metagenome analysis of normal middle ear cavity
Region
| Japan |
Condition
Condition
non-infectous middle or inner ear disease
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify normal bacterial colony in the middle ear using metagenome
Basic objectives2
Others
Basic objectives -Others
To identify normal bacterial colony in the middle ear using metagenome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
N/A
Key secondary outcomes
N/A
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
otosclerosis
auditory ossicular malformation
severe sensorineural hearing loss
bell's palsy
perilymph fistula
Key exclusion criteria
patients who do not give informed consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Oishi |
Organization
Keio University School of Medicine
Division name
Otolaryngology- head and neck surgery
Zip code
Address
35 Shinanomachi, Shinjuku
TEL
03-5363-3827
oishi_naoki@z5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Oishi |
Organization
Keio University School of Medicine
Division name
Otolaryngology- head and neck surgery
Zip code
Address
35 Shinanomachi, Shinjuku
TEL
03-5363-3827
Homepage URL
oishi_naoki@z5.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 01 | 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
| 2014 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | 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
Metagenome analysis
Management information
Registered date
| 2014 | Year | 03 | Month | 28 | Day |
Last modified on
| 2018 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015832
