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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000421
Receipt No. R000000513
Scientific Title Study on diagnostic accuracy of magnified narrow band imaging (NBI) for small depressive lesion in the stomach
Date of disclosure of the study information 2006/05/20
Last modified on 2010/06/09

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Basic information
Public title Study on diagnostic accuracy of magnified narrow band imaging (NBI) for small depressive lesion in the stomach
Acronym NBI study for gastric small lesion
Scientific Title Study on diagnostic accuracy of magnified narrow band imaging (NBI) for small depressive lesion in the stomach
Scientific Title:Acronym NBI study for gastric small lesion
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To estimate the diagnostic accuracy of magnified NBI for gastric small depressive lesion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes (1) Diagnostic sensitivity
(2) Diagnostic specificity
Key secondary outcomes Time required for confirming the endoscopic diagnosis

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Magnified endoscopic examination with NBI system
Interventions/Control_2 Magnified endoscopic examination without NBI system
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 reddish depressive lesion within 10mm in length without ulceration and erosion in the stomach
(2) Written informed consent
(3) 20<=age
Key exclusion criteria (1) Severe concomitant other disease
(2) User of anti-coagulant
(3) Poor condition to obtain appropriate endoscopic images
(4)Any other inappropriate condition for participating this study estimated by physician
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Muto
Organization National Cancer Center Hospital East (NCCHE)
Division name Division of Endoscopy & GI oncology
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasumasa Ezoe
Organization National Cancer Center Hospital East (NCCHE)
Division name Division of Endoscopy & GI oncology
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL 04-7133-1111
Homepage URL
Email yezoe@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital EAST
(NCCHE)
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

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
2006 Year 05 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/20189506
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
2006 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2006 Year 03 Month 01 Day
Last follow-up date
2008 Year 02 Month 01 Day
Date of closure to data entry
2008 Year 02 Month 01 Day
Date trial data considered complete
2008 Year 08 Month 01 Day
Date analysis concluded
2008 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 05 Month 17 Day
Last modified on
2010 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000513

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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