UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038902 |
|---|---|
| Receipt number | R000041568 |
| Scientific Title | Comprehensive genetic analysis to identify causative mutations of diseases in the field of pediatric surgery |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2022/12/18 09:14:20 |
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Basic information
Public title
Comprehensive genetic analysis to identify causative mutations of diseases in the field of pediatric surgery
Acronym
Comprehensive genetic analysis of diseases in pediatric surgery
Scientific Title
Comprehensive genetic analysis to identify causative mutations of diseases in the field of pediatric surgery
Scientific Title:Acronym
Comprehensive genetic analysis of diseases in pediatric surgery
Region
| Japan |
Condition
Condition
Congenital digestive tract atresia, gastrointestinal motility disorder, intestinal malrotation, congenital gastrointestinal malformation, Hirschsprung disease, anorectal malformation, neonatal gastrointestinal perforation, pancreaticobiliary maljunction, biliary atresia, portal hypertension, liver fibrosis, congenital airway disease, pulmonary cystic disease, diaphragmatic hernia, vascular or lymphatic malformation, tumor disease, abdominal wall dysplasia, renal urological malformation, malformation syndrome, etc.
Classification by specialty
| Surgery in general | Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To identify causative mutations of diseases in the field of pediatric surgery
Basic objectives2
Others
Basic objectives -Others
To identify causative mutations of diseases in the field of pediatric surgery and develop new treatments, tests, and preventions
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of causative mutations suggesting possible involvement in the development of each pediatric surgical disease
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pediatric surgical patients with suspected genetic association
Key exclusion criteria
no consent for this study before the operation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Oshima |
Organization
Nagoya University Graduate school of Medicine
Division name
Department of Pediatric Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Naogya
TEL
052-744-2959
oshima_kazuo@hotmail.com
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Oshima |
Organization
Nagoya University Graduate school of Medicine
Division name
Department of Pediatric Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Naogya
TEL
052-744-2959
Homepage URL
oshima_kazuo@hotmail.com
Sponsor or person
Institute
Nagoya University Graduate school of Medicine
Department of Pediatric Surgery
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate school of Medicine
Department of Pediatric Surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Naogya
Tel
052-744-2959
k-oshima@nagoya-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
743
Org. issuing International ID_1
Toyohashi Municiple Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | 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
| 2019 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comprehensive genetic analysis to identify causative mutations of diseases in the field of pediatric surgery
Management information
Registered date
| 2019 | Year | 12 | Month | 16 | Day |
Last modified on
| 2022 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041568
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
