UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001697 |
|---|---|
| Receipt number | R000002045 |
| Scientific Title | Genetic study of spinal scoliosis |
| Date of disclosure of the study information | 2009/02/09 |
| Last modified on | 2023/02/20 09:44:38 |
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Basic information
Public title
Genetic study of spinal scoliosis
Acronym
Genetic study of scoliosis
Scientific Title
Genetic study of spinal scoliosis
Scientific Title:Acronym
Genetic study of scoliosis
Region
| Japan | Asia(except Japan) | North America |
Condition
Condition
adolescent idiopathic scoliosis, congenital scoliosis, syndromic scoliosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To identify genes associated with development and progression of AIS, congenital scoliosis, and syndromic scoliosis
Basic objectives2
Others
Basic objectives -Others
To apply the genomic information to treatment of AIS
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
SNIPS
Key secondary outcomes
clinical data of AIS
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
| 10 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cobb angle of 20 degrees or more
Key exclusion criteria
non- AIS
Target sample size
9000
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Watanabe |
Organization
Keio University
Division name
Dept. of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku, Tokyo
TEL
03-3353-1211
kw197251@keio.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Watanabe |
Organization
Keio University
Division name
Dept. of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku, Tokyo
TEL
03-3353-1211
Homepage URL
kw197251@keio.jp
Sponsor or person
Institute
Dept. of Orthopaedic Surgery, Keio Universtiy
Institute
Department
Personal name
Funding Source
Organization
Institutional fund of Keio University
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjyuku, 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
| 2009 | Year | 02 | Month | 09 | 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
| 2009 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Remain to be observed
Management information
Registered date
| 2009 | Year | 02 | Month | 09 | Day |
Last modified on
| 2023 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002045
| 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 |
