UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023596 |
|---|---|
| Receipt number | R000013022 |
| Scientific Title | Randomized study for the diagnosis of early esophageal cancer using the blue laser imaging endoscopy |
| Date of disclosure of the study information | 2016/08/15 |
| Last modified on | 2019/03/13 19:05:26 |
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Basic information
Public title
Randomized study for the diagnosis of early esophageal cancer using the blue laser imaging endoscopy
Acronym
Randomized study for the diagnosis of early esophageal cancer using BLI endoscopy
Scientific Title
Randomized study for the diagnosis of early esophageal cancer using the blue laser imaging endoscopy
Scientific Title:Acronym
Randomized study for the diagnosis of early esophageal cancer using BLI endoscopy
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of magnifying endoscopy using blue laser imaging for detection of early esophageal squamous cell carcinoma compared with narrow band imaging
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
compare the detection ability of early esophageal squamous cell carcinoma in narrow band imaging and blue laser imaging
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
White light and NBI study
Interventions/Control_2
White light and BLI study
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
current or previous head and neck cancer or
previous (moreover six months before) superficial esophageal cancer
Informed consent was obtained
Key exclusion criteria
esophageal adenocarcinoma
allergies of iodine
medication of anticoagulant
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tatsuyuki |
| Middle name | |
| Last name | Kawano |
Organization
Tokyo Medical and Dental University
Division name
Gastrointestinal surgery
Zip code
113-8519
Address
Yushima 1-5-45, Bunkyoku, Tokyo, Japan
TEL
03-5803-5254
kawano.srg1@tmd.ac.jp
Public contact
Name of contact person
| 1st name | kenro |
| Middle name | |
| Last name | kawada |
Organization
Tokyo Medical and Dental University
Division name
Gastrointestinal surgery
Zip code
113-8519
Address
Yushima
TEL
03-5803-5254
Homepage URL
kawada.srg1@tmd.ac.jp
Sponsor or person
Institute
TokyoMedical and dental universit
Institute
Department
Personal name
Funding Source
Organization
none
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
Department of gastrointestinal surgery, Tokyo medical and dental university
Address
Yushima 1-5-45, Bunkyoku, Tokyo ,Japan
Tel
0358035254
kawano.srg1@tmd.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 15 | 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
513
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
| 2013 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 12 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 13 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 12 | Day |
Last modified on
| 2019 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013022
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/03/13 | 実施計画書2013.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2019/03/13 | NBI・BLI研究概要.pptx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/03/13 | NBI-BLI study data固定.xlsx |
