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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001697
Receipt No. R000002045
Scientific Title Genetic study of spinal scoliosis
Date of disclosure of the study information 2009/02/09
Last modified on 2019/02/18

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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
Middle name
Last name Kota Watanabe
Organization Keio University
Division name Dept. of Orthopaedic Surgery
Zip code
Address 35 Shinanomachi, Shinjyuku, Tokyo
TEL 03-3353-1211
Email kw197251@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kota Watanabe
Organization Keio University
Division name Dept. of Orthopaedic Surgery
Zip code
Address 35 Shinanomachi, Shinjyuku, Tokyo
TEL 03-3353-1211
Homepage URL
Email kw197251@keio.jp

Sponsor
Institute Dept. of Orthopaedic Surgery, Keio Universtiy
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 03 Month 31 Day
Date trial data considered complete
2023 Year 03 Month 31 Day
Date analysis concluded
2023 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
2019 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002045

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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