UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013893 |
|---|---|
| Receipt number | R000015549 |
| Scientific Title | The usefulness of magnifying endoscopy with Blue LASER Imaging (ME-BLI) for superficial esophageal squamous cell carcinoma (SCC) |
| Date of disclosure of the study information | 2014/05/07 |
| Last modified on | 2023/02/09 14:41:41 |
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Basic information
Public title
The usefulness of magnifying endoscopy with Blue LASER Imaging (ME-BLI) for superficial esophageal squamous cell carcinoma (SCC)
Acronym
Esophageal BLI (Blue LASER Imaging) study
Scientific Title
The usefulness of magnifying endoscopy with Blue LASER Imaging (ME-BLI) for superficial esophageal squamous cell carcinoma (SCC)
Scientific Title:Acronym
Esophageal BLI (Blue LASER Imaging) study
Region
| Japan |
Condition
Condition
superficial esophageal SCC
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of ME-BLI compared to magnifying endoscopy with Narrow Band Imaging (ME-NBI) for the diagnosis of invasion depth of the tumor in superficial esophageal SCC
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The accuracy rate of invasion depth of the targeted region in superficial esophageal SCC
Key secondary outcomes
Interobserver agreement between two blind reviewers for the diagnosis of invasion depth of the targeted area in superficial esophageal SCC
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
To diagnose the invasion depth of superficial esophageal SCC by two modalities such as ME-BLI and ME-NBI (two examinations are performed in the different days
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
1) The patients with superficial esophageal SCCs treated by endoscopic resection or surgical resection
2) The patients who agreed with informed consent
Key exclusion criteria
1) The patients with previous histological diagnosis of esophageal dysplasia or cancer
2) The patients with any previous treatments for esophageal diseases
Target sample size
178
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Koike |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7171
tkoike@rd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Waku |
| Middle name | |
| Last name | Hatta |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7171
Homepage URL
waku-style@festa.ocn.ne.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Fujifilm corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Hospital Ethics Committee
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-7146
rinri-2@proj.med.tohoku.ac.jp
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 07 | 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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 06 | Day |
Last modified on
| 2023 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015549
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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