UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020107 |
|---|---|
| Receipt number | R000023227 |
| Scientific Title | Clinical study on the usefulness of enteral diet load test that applies a useful white opaque substance in the diagnosis of gastric epithelial tumors (adenomas, gastric cancer) |
| Date of disclosure of the study information | 2015/12/15 |
| Last modified on | 2015/12/28 13:32:02 |
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Basic information
Public title
Clinical study on the usefulness of enteral diet load test that applies a useful white opaque substance in the diagnosis of gastric epithelial tumors (adenomas, gastric cancer)
Acronym
ED loading test
Scientific Title
Clinical study on the usefulness of enteral diet load test that applies a useful white opaque substance in the diagnosis of gastric epithelial tumors (adenomas, gastric cancer)
Scientific Title:Acronym
ED loading test
Region
| Japan |
Condition
Condition
Gastric epithelial tumors (adenomas, gastric cancer)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Useful for the diagnosis of white opaque substance gastric epithelial tumors (adenomas, gastric) by enteral diet load?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference between the fat load test positive rate in the load group and the non-load (control) group
Key secondary outcomes
Color change in the epithelial tumors before and after enteral diet load test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
1 cans to the subject a ENSURE H (250mL, 375kcal) only once to administration (completed in one day)
Interventions/Control_2
No Load
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Men and women 20 years of age or older to receive an endoscopic resection for gastric epithelial tumors
Key exclusion criteria
Patients who did not consent to the test
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenshi Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Depatrtment of Endoscopy
Zip code
Address
1-1-1, Zokumyoin, Chikushino city, Fukuoka, Japan
TEL
092-921-1011
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruhiko Takahashi |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-1-1, Zokumyoin, Chikushino city, Fukuoka, Japan
TEL
092-921-1011
Homepage URL
harutakahashi@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Central institute for Endoscopy
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Central institute for Endoscopy
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
福岡大学筑紫病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 15 | 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
| 2015 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 07 | Day |
Last modified on
| 2015 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023227
