UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030161 |
|---|---|
| Receipt number | R000034445 |
| Scientific Title | Usefulness of LCI (Linked Color Imaging) for Early Gastric Cancer |
| Date of disclosure of the study information | 2017/11/28 |
| Last modified on | 2017/11/28 20:34:24 |
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Basic information
Public title
Usefulness of LCI (Linked Color Imaging) for Early Gastric Cancer
Acronym
Usefulness of LCI (Linked Color Imaging) for Early Gastric Cancer
Scientific Title
Usefulness of LCI (Linked Color Imaging) for Early Gastric Cancer
Scientific Title:Acronym
Usefulness of LCI (Linked Color Imaging) for Early Gastric Cancer
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the usefulness of LCI for early gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of WLI and LCI images
Comparison of "color" findings and pathological findings in LCI images
Key secondary outcomes
Consensus rate of WLI observation and LCI observation diagnosis among image evaluators
Comparison of color differences between WLI and LCI
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have a therapy for early gastric cancer
Key exclusion criteria
Patient whom a resercher judged to be inappropriate as a subject
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Hirooka |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Endoscopy
Zip code
Address
65, Tsuruma-cho Showa-ku, Nagoya, Japan
TEL
052-744-2431
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihisa Fujiyoshi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65, Tsuruma-cho Showa-ku, Nagoya, Japan
TEL
052-744-2431
Homepage URL
t-fuji@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine, department of Gastroenterology and Hepatology
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
| 2017 | Year | 11 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical observation study
Management information
Registered date
| 2017 | Year | 11 | Month | 28 | Day |
Last modified on
| 2017 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034445
