UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011324 |
|---|---|
| Receipt number | R000013270 |
| Scientific Title | The utility of Blue LASER Imaging for the diagnosis of gastric cancer |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2018/11/11 09:40:58 |
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Basic information
Public title
The utility of Blue LASER Imaging for the diagnosis of gastric cancer
Acronym
The utility of Blue LASER Imaging for the diagnosis of gastric cancer
Scientific Title
The utility of Blue LASER Imaging for the diagnosis of gastric cancer
Scientific Title:Acronym
The utility of Blue LASER Imaging for the diagnosis of gastric cancer
Region
| Japan |
Condition
Condition
early gastric cancer and suspicious of early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of detection ability of early gastric cancer by Blue LASER Imaging. To clarify the usefulness of the diagnosis of magnified endoscopic images with Blue LASER Imaging for early gastric cancer or suspicious of early gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection ability of early gastric cancer by Blue LASER Imaging and diagnosis ability of magnified endoscopic images by Blue LASER Imaging according to VS classification
Key secondary outcomes
Degree of diagnosis agreement according to VS classification of magnified endoscopic images with Blue LASER Imaging and narrow band imaging
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Blue LASER Imaging-white light imaging group
Interventions/Control_2
white light imaging-Blue LASER Imaging group
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 chronic atrophic gastritis, past history of gastric cancer or suspicious of gastric cancer
Key exclusion criteria
Patients who do not have chronic atrophic gastritis, past history of gastric cancer and suspicious of gastric cancer
Patients whom a researcher judged to be inappropriate as a subject
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Dohi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kawaramachi Hirokoji Kamigyo-ku, Kyoto
TEL
075-251-5519
Homepage URL
osamu-d@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine Department of Molecular Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto Prefectural University of Medicine Department of Molecular Gastroenterology and Hepatology
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
京都府立医科大学附属北部医療センター
京都府立医科大学
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 30 | Day |
Last modified on
| 2018 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013270
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
