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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028328
Receipt No. R000032411
Scientific Title Diagnostic efficacy for gastric cancer by Linked color image compare to White light image
Date of disclosure of the study information 2017/07/24
Last modified on 2017/07/21

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Basic information
Public title Diagnostic efficacy for gastric cancer by Linked color image compare to White light image
Acronym Diagnosis for gastric cancer by Linked color image
Scientific Title Diagnostic efficacy for gastric cancer by Linked color image compare to White light image
Scientific Title:Acronym Diagnosis for gastric cancer by Linked color image
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of diagnosis for gastric cancer by Linked color image compare to white light image
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Comparison between white light image and Linked color image for visibility score, and detection rate
Key secondary outcomes Accuracy, evaluation of characteristic of lesions which cannot be correctly diagnosed by white light image and Lincked color image, respectively

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 short movie of LCI
Interventions/Control_2 short movie of WLI
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients who have lesions for treatment, and were referred to our hospital, and need ditail examination
Key exclusion criteria 1. dirty stomach
2. Remnant stomach
3. Gastric tube
4. Peptic ulcer scar
5. History of endoscopic treatment
6. No consent for sedation
7. Pregnant
8. Mental illness
Target sample size 95

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Osawa, M.D., Ph.D
Organization Jichi medical University
Division name Department of Internal Medicine, Division of Gastroenterology
Zip code
Address 3311-1, Yakushiji, shimotsuke, Tochigi
TEL 0285-58-7539
Email osawa@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimasa Miura, M.D.
Organization Jichi Medical University
Division name Department of Internal Medicine, Division of Gastroenterology
Zip code
Address 3311-1, Yakushiji, shimotsuke, Tochigi
TEL 0285-58-7539
Homepage URL
Email y-miura@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization FUJIFILM MEDICAL Corporation
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 07 Month 24 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 No longer recruiting
Date of protocol fixation
2016 Year 05 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 03 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
2017 Year 07 Month 21 Day
Last modified on
2017 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032411

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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