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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | adolescent idiopathic scoliosis, congenital scoliosis, syndromic scoliosis | |
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Organization | Keio University | ||||||
Division name | Dept. of Orthopaedic Surgery | ||||||
Zip code | |||||||
Address | 35 Shinanomachi, Shinjyuku, Tokyo | ||||||
TEL | 03-3353-1211 | ||||||
kw197251@keio.jp |
Public contact | |||||||
Name of contact person |
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Organization | Keio University | ||||||
Division name | Dept. of Orthopaedic Surgery | ||||||
Zip code | |||||||
Address | 35 Shinanomachi, Shinjyuku, Tokyo | ||||||
TEL | 03-3353-1211 | ||||||
Homepage URL | |||||||
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 |
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IRB Contact (For public release) | |
Organization | |
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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 |
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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 | |
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Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | Remain to be observed |
Management information | |||||||
Registered date |
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Last modified on |
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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 |