UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056953 |
|---|---|
| Receipt number | R000065082 |
| Scientific Title | A study of the family history of patients with ossification of the spinal ligament |
| Date of disclosure of the study information | 2025/02/10 |
| Last modified on | 2025/02/06 12:15:26 |
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Basic information
Public title
A study of the family history of patients with ossification of the spinal ligament
Acronym
A study of the family history of patients with ossification of the spinal ligament
Scientific Title
A study of the family history of patients with ossification of the spinal ligament
Scientific Title:Acronym
A study of the family history of patients with ossification of the spinal ligament
Region
| Japan |
Condition
Condition
Ossification of the spinal ligaments
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In order to clarify family history that may be a factor in the pathology of ossification of the spinal ligament, blood tests, CT scans, X-rays, and genetic tests will be conducted on patients and their families to examine any associations with the pathology.
Basic objectives2
Others
Basic objectives -Others
As this may provide clues to understanding the genetic factors, we will conduct tests and surveys on patients with ossification of the spinal ligament and their families to examine the relationship between genetic factors and the pathology.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
X-ray evaluation (type classification: continuous type, segmental type, mixed type, other type)
Key secondary outcomes
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient group
Control group (family members of patients without ossification of the spinal ligament)
Key exclusion criteria
Those who do not agree to participate in the study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | YOSHIHARU |
| Middle name | |
| Last name | KAWAGUCHI |
Organization
Toyama University Hospital
Division name
Orthopedics
Zip code
930-0152
Address
Toyama-Ken Toyama-city Sugitani 2630
TEL
0764347353
zenji@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | YOSHIHARU |
| Middle name | |
| Last name | KAWAGUCHI |
Organization
Toyama University Hospital
Division name
Orthopaedics
Zip code
9300152
Address
Toyama-Ken Toyama-city Sugitani 2630
TEL
0764347353
Homepage URL
zenji@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama University
Institute
Department
Personal name
Funding Source
Organization
Toyama 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
Toyama University Human Research Ethics Office
Address
Toyama-Ken Toyama-city Sugitani 2630
Tel
0764347353
kenrinri@adm.u-toyama.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before the start of research
Management information
Registered date
| 2025 | Year | 02 | Month | 06 | Day |
Last modified on
| 2025 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065082
