UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011224
Receipt number 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 2021/01/26 13:03:07

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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 or person

Institute

Juntendo University

Institute

Department

Personal name



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

Completed

Date of protocol fixation

2013 Year 07 Month 01 Day

Date of IRB

2013 Year 02 Month 19 Day

Anticipated trial start date

2013 Year 07 Month 18 Day

Last follow-up date

2019 Year 01 Month 31 Day

Date of closure to data entry

2019 Year 06 Month 30 Day

Date trial data considered complete

2019 Year 07 Month 31 Day

Date analysis concluded

2019 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 07 Month 18 Day

Last modified on

2021 Year 01 Month 26 Day



Link to view the page

Value
https://center6.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