UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000421 |
|---|---|
| Receipt number | 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 21:00:46 |
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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
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
yezoe@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital EAST
(NCCHE)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000513
