UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028328 |
|---|---|
| Receipt number | 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 19:17:39 |
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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
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
y-miura@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032411
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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