UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010676 |
|---|---|
| Receipt number | R000012484 |
| Scientific Title | Evaluation of utility of liver and spleen stiffness measurement by acoustic radiation force impulse (ARFI) imaging in long-term follow-up for pediatric liver disease |
| Date of disclosure of the study information | 2013/05/09 |
| Last modified on | 2013/05/09 16:22:31 |
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Basic information
Public title
Evaluation of utility of liver and spleen stiffness measurement by acoustic radiation force impulse (ARFI) imaging in long-term follow-up for pediatric liver disease
Acronym
Liver and spleen stiffness measurement for pediatric liver disease
Scientific Title
Evaluation of utility of liver and spleen stiffness measurement by acoustic radiation force impulse (ARFI) imaging in long-term follow-up for pediatric liver disease
Scientific Title:Acronym
Liver and spleen stiffness measurement for pediatric liver disease
Region
| Japan |
Condition
Condition
Pediatric liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Pediatrics |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the reproducibility and variability of liver and spleen stiffness measurement by ARFI imaging.
To develop an algorithm for the evaluation in follow-up of pediatric liver disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Liver and spleen stiffness measurement by ARFI imaging.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Ultrasound examination.
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
1) Subjects who are followed up for pediatric liver disease.
2) Subjects who give a written informed consent.
Key exclusion criteria
1) Subjects who have hepatitis B or C.
2) Subjects who do not give a written informed consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Hoshino |
Organization
Keio University School of Medicine
Division name
Department of Pediatric Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Tomita |
Organization
Keio University School of Medicine
Division name
Department of Pediatric Surgery
Zip code
Address
TEL
Homepage URL
htomita@a3.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 05 | Month | 09 | 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 | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 09 | 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 | 05 | Month | 08 | Day |
Last modified on
| 2013 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012484
