UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030197 |
|---|---|
| Receipt number | 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 | 2019/12/22 07:16:04 |
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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 | 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
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
takamasa@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034492
