UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058096 |
|---|---|
| Receipt number | R000066397 |
| Scientific Title | Analysis of craniosynostosis by geometric analysis. |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/06/05 17:39:45 |
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Basic information
Public title
Analysis of craniosynostosis by geometric analysis.
Acronym
Analysis of craniosynostosis
Scientific Title
Analysis of craniosynostosis by geometric analysis.
Scientific Title:Acronym
Analysis of craniosynostosis
Region
| Japan |
Condition
Condition
craniosynostosis
Classification by specialty
| Neurosurgery | Plastic surgery | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Craniosynostosis is a rare disease in which the cranial suture closes prematurely, either congenitally or acquired. Premature closure of the suture results in insufficient cranial expansion in response to rapid brain growth during the first six months of life, leading to increased intracranial pressure and skull deformity, which adversely affects normal brain development. Although deformities of typical cases can be identified, there are many cases where this is not the case, and these deformities are defined on the basis of morphologically objective image data.
Basic objectives2
Others
Basic objectives -Others
isual craniofacial deformity is necessary to screen for this disease. However, screening by visual examination is difficult unless a doctor is professional with the disease. It is also necessary to differentiate it from sleeping sickness. Therefore, it is not uncommon for patients to be followed up, and delayed detection of the disease is a problem in Japan.
The aim of this study is to establish an easy screening method by comparing normal cranial deformities with pathological conditions and treating cranial deformities as objective data, rather than visual examination based on the experience of experts.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3D cranial morphology
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
| 1 | days-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Number of patients diagnosed and treated for craniosynostosis, as well as normal patients who presented for trauma and had a head CT scan.
Key exclusion criteria
Cases in which the individual or a surrogate has indicated his/her refusal when consenting to participate in the study (as is the patient's right).
Other cases in which the responsible person at the respective institution considers the subject to be unsuitable for the study (insufficient data for analysis due to rough CT).
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Sakamoto |
Organization
Keio University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1054
prssakamoto@gmail.com
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Sakamoto |
Organization
Keio University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1054
Homepage URL
prssakamoto@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
None
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
ethical review board of Keio University school of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
keio-ctr-coijim@adst.keio.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 | 08 | 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
| 2021 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066397
