UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018051 |
|---|---|
| Receipt number | R000020905 |
| Scientific Title | Analysis of diseases in otorhinolaryngology using iPS cells |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2023/01/17 05:40:20 |
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Basic information
Public title
Analysis of diseases in otorhinolaryngology using iPS cells
Acronym
otorhinolaryngology disease specific iPSc
Scientific Title
Analysis of diseases in otorhinolaryngology using iPS cells
Scientific Title:Acronym
otorhinolaryngology disease specific iPSc
Region
| Japan | North America |
Condition
Condition
Intractable otorhinolaryngology diseases
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To explore pathophysiology of intractable otorhinolaryngology diseases using disease specific- human iPS cells
Basic objectives2
Others
Basic objectives -Others
Search for new medication based on the analyses of pathophysiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Phenotype of cell lines derived from intractable otorhinolaryngology diseases patients
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Intractable otorhinolaryngolgy disease patients, and healthy normal control.
Key exclusion criteria
Patients without informed concent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ozawa |
Organization
Keio University School of Medicine
Division name
Department of Otolaryngology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku, Tokyo
TEL
03-5363-3827
ogawak@a5.keio.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Fujioka |
Organization
Kitasato University
Division name
School of Medicine
Zip code
252-0374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374 Japan
TEL
042-778-8111
Homepage URL
mtfuji@keio.jp
Sponsor or person
Institute
Department of Otolaryngology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MHLW, JSPS, AMED, Self funding
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
none
Address
none
Tel
none
none
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 | 07 | Month | 01 | 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
| 2014 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | 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
An open label study establishing disease specific- and control human iPS cells and evaluating their phenotypes in vitro
Management information
Registered date
| 2015 | Year | 06 | Month | 24 | Day |
Last modified on
| 2023 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020905
