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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011224
Receipt No. R000013151
Scientific Title Screening for biliary atresia using digital photos with stool color card.
Date of disclosure of the study information 2013/07/18
Last modified on 2017/01/19

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Basic information
Public title Screening for biliary atresia using digital photos with stool color card.
Acronym Screening for biliary atresia using digital photos with stool color card.
Scientific Title Screening for biliary atresia using digital photos with stool color card.
Scientific Title:Acronym Screening for biliary atresia using digital photos with stool color card.
Region
Japan

Condition
Condition biliary atresia
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To improve an early checkup rate of the biliary atresia easily by judging the stool color using the photograph of the cell-phone from newborn to three months old.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes usefulness of the judgment method of the stool color using the color card
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 We direct mother after the delivery to have us e-mail a photograph of the stool of the neonate or infant and judge presence of the stool color abnormality.
We have mother e-mail it by three months after birth.
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
0 months-old <=
Age-upper limit
3 months-old >=
Gender Male and Female
Key inclusion criteria We study it for full-term newborn babies. We explain about study to mother and obtain its consent. Mother of the babies use cell phone and mail a photo to us.
Key exclusion criteria We exclude the patient who does not meet the criteria for selection mentioned above.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroko Watayo
Organization Juntendo University School of Medicine
Division name Pediatric General & Urogenital Surgery
Zip code
Address 2-1-1 Hongo, Bunkyo-ku Tokyo
TEL 03-3813-3111
Email watayo@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Watayo
Organization Juntendo University School of Medicine
Division name Pediatric General & Urogenital Surgery
Zip code
Address 2-1-1 Hongo, Bunkyo-ku Tokyo
TEL 03-3813-3111
Homepage URL http://plaza.umin.ac.jp/unchiproject/
Email unchi-project@umin.org

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 07 Month 18 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
2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 18 Day
Last modified on
2017 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013151

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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