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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020107
Receipt No. 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

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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
Email 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
Email harutakahashi@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Central institute for Endoscopy
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023227

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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