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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030197
Receipt No. R000034492
Scientific Title A genome-wide association study of thoracic ossification of posterior longitudinal ligament
Date of disclosure of the study information 2018/01/01
Last modified on 2018/12/03

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Basic information
Public title A genome-wide association study of thoracic ossification of posterior longitudinal ligament
Acronym GWAS for thoracic OPLL
Scientific Title A genome-wide association study of thoracic ossification of posterior longitudinal ligament
Scientific Title:Acronym GWAS for thoracic OPLL
Region
Japan

Condition
Condition Thoracic ossification of posterior longitudinal ligament
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To identify genetic factor for thoracic OPLL.
Basic objectives2 Others
Basic objectives -Others To identify environmental factor for thoracic OPLL.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes To identify single nucleotide polymorphisms (SNIPs) associated with the development of thoracic OPLL by genome wide association study
Key secondary outcomes To identify environmental factors associated with the development of thoracic OPLL

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients in whom thoracic ossification of posterior longitudinal ligament is confirmed on computed tomography.
Key exclusion criteria Patients will not get consent
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Takahata
Organization Hokkaido University
Division name School of Medicine, Department of Orthopaedic Surgery
Zip code
Address Kita-15 Nishi-7, Kita-ku, Sappporo, Japan
TEL 011-706-5934
Email takamasa@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Takahata
Organization Hokkaido University
Division name School of Medicine, Department of Orthopaedic Surgery
Zip code
Address Kita-15 Nishi-7, Kita-ku, Sappporo, Japan
TEL 011-706-5934
Homepage URL
Email takamasa@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Hokkaido university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor RIKEN
Name of secondary funder(s) AOSpine Research Grant
Suhara Zaidan

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 北海道大学病院(北海道),名古屋大学病院(愛知県),大阪大学病院(大阪府),金沢大学(石川県),北海道医療センター(北海道),北海道せき損センター(北海道),帯広厚生病院(北海道),北海道整形外科記念病院(北海道),函館中央病院(北海道)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 01 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
2017 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
2019 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Main Observation Item:
Whole genome information by GWAS

Management information
Registered date
2017 Year 11 Month 30 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034492

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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