UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041408 |
|---|---|
| Receipt number | R000046395 |
| Scientific Title | Registry research around the nation for rare and intractable diseases associated with deafblindness |
| Date of disclosure of the study information | 2020/08/17 |
| Last modified on | 2022/09/06 12:58:25 |
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Basic information
Public title
Registry research around the nation for rare and intractable diseases associated with deafblindness
Acronym
Research on deafblindness
Scientific Title
Registry research around the nation for rare and intractable diseases associated with deafblindness
Scientific Title:Acronym
Research for rare and intractable diseases associated with deafblindness
Region
| Japan |
Condition
Condition
deafblindness
Classification by specialty
| Pediatrics | Ophthalmology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To accumulate background, clinical, and genome information of the patients of rare and intractable diseases associated with deafblindness.
Basic objectives2
Others
Basic objectives -Others
To produce evidences for clinical guidelines, etc. for the diseases of the present study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of 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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet all the criteria below are included in the present study. Relatives of these patients are also included if necessary.
1)Patients who have both vision and hearing impairment
2)Patients who developed both vision and hearing impairment under the age of 40
3)Patients whose vision and hearing impairment may be derived from the same cause
4)Patients from whom consent for participation in the research can be obtained by document
Key exclusion criteria
Patients who meet any of the criteria below are excluded from enrollment in the present study.
1)Patients with vision and hearing impairment which are caused by only environmental factors such as injuries after birth
2)Patients who has vision impairment by common refractive errors and the like which can be corrected by glasses and the like
3)Patients who has hearing impairment by common otitis media and the like which can be recovered
4)Patients who have only age-related vision impairment or hearing impairment
5)Patients who are considered to be inappropriate as the subjects by researches and the like
Target sample size
2600
Research contact person
Name of lead principal investigator
| 1st name | Tatsuo |
| Middle name | |
| Last name | Matsunaga |
Organization
National Hospital Organization Tokyo Medical Center
Division name
National Institute of Sensory Organs, Division of Hearing and Balance Research
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro, Tokyo 152-8902, Japan
TEL
03-3411-0111
tatsuo.matsunaga@kankakuki.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Matsunaga |
Organization
National Hospital Organization Tokyo Medical Center
Division name
National Institute of Sensory Organs, Division of Hearing and Balance Research
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro, Tokyo 152-8902, Japan
TEL
03-3411-0111
Homepage URL
tatsuo.matsunaga@kankakuki.jp
Sponsor or person
Institute
National Hospital Organization Tokyo Medical Center, National Institute of Sensory Organs
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
G1207-1
Org. issuing International ID_1
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 17 | 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
| 2019 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2040 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we conduct follow-up survey of background information, life environments, life conditions, symptoms, therapeutic histories, etc. in patients with deafblindness with congenital or early onset.
Management information
Registered date
| 2020 | Year | 08 | Month | 13 | Day |
Last modified on
| 2022 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046395
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
