UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026932 |
|---|---|
| Receipt number | R000030896 |
| Scientific Title | prospective cohort study in biliary atresia |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2017/10/10 20:58:53 |
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Basic information
Public title
prospective cohort study in biliary atresia
Acronym
prospective cohort study in biliary atresia
Scientific Title
prospective cohort study in biliary atresia
Scientific Title:Acronym
prospective cohort study in biliary atresia
Region
| Japan |
Condition
Condition
biliary atresia
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of relationship between jaundice free native liver survival and various prognostic markers
Basic objectives2
Others
Basic objectives -Others
evaluated marker are serum/urine oxysterols, histrogical findings in liver and portal remnant and microRNA expression in liver
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year native liver survival
Key secondary outcomes
jaundice disappearance rate after porto-enterostomy
incidence of cholangitis
incidence of esophageal varices
incidence of hypersplenism
5-year overall survival
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
| 1 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
compatible with classification of biliary atreisa
Key exclusion criteria
incompatible with classification of biliary atreisa
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Nioi |
Organization
Tohoku University
Division name
Graduate School of Medicine, Devision of Pediatric Surgery
Zip code
Address
Seiryo-machi 1-1, Aoba-ku, Sendai
TEL
022-717-7237
mnio@ped-surg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Sasaki |
Organization
Tohoku University
Division name
Hospital
Zip code
Address
Seiryo-machi 1-1, Aoba-ku, Sendai
TEL
022-717-7237
Homepage URL
h-sasaki@ped-surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
clinical data are registered by CRF
Management information
Registered date
| 2017 | Year | 04 | Month | 10 | Day |
Last modified on
| 2017 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030896
