UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035084 |
|---|---|
| Receipt number | R000039906 |
| Scientific Title | The diagnostic ability for gastrointestinal and hepatobiliary-pancreatic disease by ultrasound including ultrasound elastography |
| Date of disclosure of the study information | 2018/11/30 |
| Last modified on | 2021/08/28 07:04:47 |
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Basic information
Public title
The diagnostic ability for gastrointestinal and hepatobiliary-pancreatic disease by ultrasound including ultrasound elastography
Acronym
The diagnostic ability for gastrointestinal and hepatobiliary-pancreatic disease by ultrasound including ultrasound elastography
Scientific Title
The diagnostic ability for gastrointestinal and hepatobiliary-pancreatic disease by ultrasound including ultrasound elastography
Scientific Title:Acronym
The diagnostic ability for gastrointestinal and hepatobiliary-pancreatic disease by ultrasound including ultrasound elastography
Region
| Japan |
Condition
Condition
Gastrointestinal and hepatobiliary-pancreatic disease
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the diagnostic ability of gastrointestinal and hepatobiliary-pancreatic disease using ultrasonography
Basic objectives2
Others
Basic objectives -Others
The diagnostic accuracy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the consistency between ultrasonic diagnosis and final diagnosis of gastrointestinal and hepatobiliary-pancreatic 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
Patients with histopathological diagnosis
Key exclusion criteria
Patients without histopathological diagnosis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroko Iijima |
Organization
Hyogo College of Medicine
Division name
Ultrasound Imaging Center
Zip code
Address
1-1, Mukogawacho, Nishinomiya, Hyogo
TEL
0798-45-6316
hiroko-i@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nishimura |
Organization
Hyogo College of Medicine
Division name
Ultrasound Imaging Center
Zip code
Address
1-1, Mukogawacho, Nishinomiya, Hyogo
TEL
0798-45-6316
Homepage URL
tk-nishimura@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2018 | Year | 11 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 22 | Day |
Date of closure to data entry
| 2021 | Year | 08 | Month | 22 | Day |
Date trial data considered complete
| 2021 | Year | 08 | Month | 22 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 22 | Day |
Other
Other related information
Study subjects will include not only malignant tumors but also begnin tumor and inflammatory disease.
Management information
Registered date
| 2018 | Year | 11 | Month | 30 | Day |
Last modified on
| 2021 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039906
