UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001769 |
|---|---|
| Receipt number | R000002100 |
| Scientific Title | Study of usefulness of the demarcation line in magnified endoscopy-combined narrow band imaging (NBI) for determining the expanded area of early-stage differentiated gastric carcinoma |
| Date of disclosure of the study information | 2009/03/12 |
| Last modified on | 2012/09/12 19:08:46 |
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Basic information
Public title
Study of usefulness of the demarcation line in magnified endoscopy-combined narrow band imaging (NBI) for determining the expanded area of early-stage differentiated gastric carcinoma
Acronym
NBI study for early-stage gastric carcinoma
Scientific Title
Study of usefulness of the demarcation line in magnified endoscopy-combined narrow band imaging (NBI) for determining the expanded area of early-stage differentiated gastric carcinoma
Scientific Title:Acronym
NBI study for early-stage gastric carcinoma
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the usefulness of the demarcation line in magnified endoscopy-combined narrow band imaging (NBI) for determining the expanded area of early-stage differentiated gastric carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic accuracy
Key secondary outcomes
(1)The rate of consistency of the boundary between the cancerous and non-cancerous mucosa(Demarcation Line) on magnified NBI and that identified in the biopsied speciment
(2)Sensitivity and specificity
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
(a)differenciated gastric carcinoma of the superficial depressed or flat types as determined at standard endoscopy
(b)Written informed consent
(c)20<= age
Key exclusion criteria
(a)Protruded and superficial elevated types
(b)Undifferenciated gastric carcinoma
(c)The lesions with ulceration
(d)Sever concomitant disease
(e)Poor condition to obtain appropriate endoscopic images
(f)Any other inappropriate condition for participating this study estimated by physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroto Kita |
Organization
Saitama Medical University International Medical Center
Division name
Division of Gastroenterology
Zip code
Address
1397-1 Yamane Hidakashi Saitama, 350-1298, Japan
TEL
042-984-0053
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kouichi Nonaka |
Organization
Saitama Medical University International Medical Center
Division name
Division of Gastroenterology
Zip code
Address
1397-1 Yamane Hidakashi Saitama, 350-1298, Japan
TEL
042-984-0053
Homepage URL
nonaka@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
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
| 2009 | Year | 03 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 03 | Month | 01 | Day |
Other
Other related information
prospective study
Management information
Registered date
| 2009 | Year | 03 | Month | 12 | Day |
Last modified on
| 2012 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002100
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
