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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007981
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009393

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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