UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045260 |
|---|---|
| Receipt number | R000051587 |
| Scientific Title | Epidemiological study of craniosynostosis in Japan using a national database |
| Date of disclosure of the study information | 2021/08/31 |
| Last modified on | 2025/02/26 12:22:14 |
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Basic information
Public title
Epidemiological study of craniosynostosis in Japan using a national database
Acronym
JAPANCranio 2021
Scientific Title
Epidemiological study of craniosynostosis in Japan using a national database
Scientific Title:Acronym
JAPANCranio 2021
Region
| Japan |
Condition
Condition
Craniosynostosis
Classification by specialty
| Neurosurgery | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect data from patients with craniosynostosis using the large-scale database constructed to serve as a basis for epidemiological studies for comparing intra- and inter- countries, as well as to analyze the factors involved in short-term and long-term outcomes.
Basic objectives2
Others
Basic objectives -Others
Descriptive statistics on the epidemiology of craniosynostosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Descriptive statistics on the epidemiology of craniosynostosis
Key secondary outcomes
Perform exploratory multivariate analysis on possible factors for blood transfusion of 25 mL or more per body weight, complications within 1 month after surgery, reoperation within 6 months after surgery, Whitaker classification score, developmental evaluation score.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who diagnosed as craniosynostosis at Tokyo Metropolitan Children's Medical Center or joint research institutes of this clinical study, and undergo first transcranial surgery between September 1, 2021 and August 31, 2026.
Key exclusion criteria
(1) Cases in which the patients or their substitutes indicates the intention of refusal to participate in this study.
(2) Others that the person in charge of registration at each facility deems inappropriate as a research subject.
Target sample size
1250
Research contact person
Name of lead principal investigator
| 1st name | Ikkei |
| Middle name | |
| Last name | Tamada |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Department of Plastic and Reconstructive Surgery
Zip code
183-8561
Address
2-8-29 Musashidai Fuchu-city Tokyo, Japan
TEL
042-300-5111
prstamada@gmail.com
Public contact
Name of contact person
| 1st name | Ikkei |
| Middle name | |
| Last name | Tamada |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Department of Plastic and Reconstructive Surgery
Zip code
183-8561
Address
2-8-29 Musashidai Fuchu-city Tokyo, Japan
TEL
042-300-5111
Homepage URL
prstamada@gmail.com
Sponsor or person
Institute
Department of Plastic and Reconstructive Surgery, Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Society of Craniosynostosis
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Board, Tokyo Metropolitan Children's Medical Center
Address
2-8-29 Musashidai Fuchu-city Tokyo, 183-8561 Japan
Tel
042-300-5111
sn_rinri@tmhp.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
地方独立行政法人東京都立病院機構東京都立小児総合医療センター（東京都）、および日本国内の共同研究機関
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 31 | 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
| 2021 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Prospective Cohort Study
Analysis of primary endpoints:
Regarding the epidemiology of Craniosynostosis cases in Japan, the median is evaluated for continuous variables, and the ratio is descriptively evaluated for qualitative variables.
Analysis of secondary endpoints:
Relationship between blood transfusion of 25 mL or more per body weight, complications within 1 month after surgery, reoperation within 6 months after surgery, Whitaker classification score, developmental evaluation score, age at surgery, surgery time, or presence or absence of syndrome and possible factors are evaluated by performing exploratory multivariate analysis.
Management information
Registered date
| 2021 | Year | 08 | Month | 25 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051587
