UMIN-CTR Clinical Trial

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 Takahata Middle name Last name Masahiko
Organization	Hokkaido University
Division name	School of Medicine, Department of Orthopaedic Surgery
Zip code	060-8638
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 Takahata Middle name Last name Masahiko
Organization	Hokkaido University
Division name	School of Medicine, Department of Orthopaedic Surgery
Zip code	060-8638
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	Hokkaido University
Address	Kita-15 Nishi-7, Kita-ku, Sappporo, Japan
Tel	011-716-2111
Email	shomu@med.hokudai.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	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），総合せき損センター（福岡県）、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	Enrolling by invitation
Date of protocol fixation	2017 Year 11 Month 30 Day
Date of IRB	2016 Year 12 Month 21 Day
Anticipated trial start date	2018 Year 01 Month 04 Day
Last follow-up date	2020 Year 12 Month 28 Day
Date of closure to data entry	2020 Year 12 Month 28 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	2019 Year 12 Month 22 Day

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