UMIN-CTR Clinical Trial

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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