UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007981 |
|---|---|
| Receipt number | R000009393 |
| Scientific Title | Endoscopic diagnosis of early squamous neoplasia of the esophagus with narrow band imaging |
| Date of disclosure of the study information | 2012/05/18 |
| Last modified on | 2013/03/28 13:18:19 |
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Basic information
Public title
Endoscopic diagnosis of early squamous neoplasia of the esophagus with narrow band imaging
Acronym
Endoscopic diagnosis of early squamous neoplasia of the esophagus with narrow band imaging
Scientific Title
Endoscopic diagnosis of early squamous neoplasia of the esophagus with narrow band imaging
Scientific Title:Acronym
Endoscopic diagnosis of early squamous neoplasia of the esophagus with narrow band imaging
Region
| Japan |
Condition
Condition
early squamous neoplasia of the esophagus
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of narrow band imaging for the diagnosis of early squamous neoplasia of the esophagus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of diagnosis of early squamous neoplasia of the esophagus with narrow band imaging
Key secondary outcomes
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
Head and neck cancer
Post EMR for early esophageal cancer
Key exclusion criteria
Patients whom a researcher judged to be inappropriate as a subject
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Shimizu |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology
Zip code
Address
N14,W5,Kita-ku,Sapporo,Hokkaido
TEL
011-716-1161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology
Zip code
Address
N14,W5,Kita-ku,Sapporo,Hokkaido
TEL
Homepage URL
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
| 2012 | Year | 05 | Month | 18 | 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
| 2010 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 11 | Month | 24 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of NBI and iodine staining
Management information
Registered date
| 2012 | Year | 05 | Month | 17 | Day |
Last modified on
| 2013 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009393
