UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003408 |
|---|---|
| Receipt number | R000004130 |
| Scientific Title | A clinical trial for evaluating diagnostic utility of magnified endoscopic examination with narrow band imaging (NBI) for reddish depressive lesion in stomach |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2016/03/16 11:14:45 |
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Basic information
Public title
A clinical trial for evaluating diagnostic utility of magnified endoscopic examination with narrow band imaging (NBI) for reddish depressive lesion in stomach
Acronym
Endoscopic diagnosis for gastric reddish depressive lesion by NBI
Scientific Title
A clinical trial for evaluating diagnostic utility of magnified endoscopic examination with narrow band imaging (NBI) for reddish depressive lesion in stomach
Scientific Title:Acronym
Endoscopic diagnosis for gastric reddish depressive lesion by NBI
Region
| Japan |
Condition
Condition
Reddish depressive lesion in stomach
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective for this study is to evaluate diagnostic utility of magnifying endoscopy with NBI for gastric reddish depressive lesion, compared to normal white light endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
To evaluate the following outcomes of magnifying endoscopy with NBI compared with those of normal white light endoscopy, when we diagnose reddish depressive lesion in stomach using these devices.
1. Primary outcomes: 1) exact diagnostic rate (verified by pathological examination), 2) sensitivity, specificity, positive predictive value, and negative predictive value (for cancer diagnosis)
Key secondary outcomes
2. Secondary outcomes: 1) to determine useful findings of magnifying endoscopy with NBI to discriminate gastric cancer from benign lesion, 2) to evaluate whether magnifying endoscopy with NBI needs extra time during examination, compared with normal white light endoscopy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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 gastrointestinal endoscopy with NBI system
Interventions/Control_2
Normal white light gastrointestinal endoscopy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who will have newly detected gastric depressed lesion, which needs to be biopsied for diagnosis, in upper gastrointestinal screening by regular endoscopy.
Key exclusion criteria
1. Lesions already diagnosed before the study
2. Obvious carcinoma
3. Non-epithelial tumor
4. Lesions which cannot be biopsied (e.g. because recipients receive anti-platelet therapy)
5. Lesions which cannot be pathologically diagnosed (e.g. because specimen is too small to be diagnosed"
6. Lesions detected by trans-nasal upper gastrointestinal endoscopy
Target sample size
752
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Yamashita |
Organization
Sapporo Medical University school of medicine
Division name
First Dept. of Int. Med.
Zip code
Address
S-1, W-17, chuo-ku, Sapporo, Hokkaido, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tokuma Tanuma |
Organization
Sapporo Medical University School of Medicine
Division name
First Dept. of Int. Med.
Zip code
Address
TEL
Homepage URL
ttokuma@sapmed.ac.jp
Sponsor or person
Institute
First Department of Internal Medicine, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
First Department of Internal Medicine, Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2010 | Year | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 30 | Day |
Last modified on
| 2016 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004130
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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