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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038902
Receipt No. 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 2020/12/16

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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
Email 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
Email oshima_kazuo@hotmail.com

Sponsor
Institute Nagoya University Graduate school of Medicine
Department of Pediatric Surgery
Institute
Department

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
Email 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
2020 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041568

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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