UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012924 |
|---|---|
| Receipt number | R000015114 |
| Scientific Title | Evaluation of the endoscopic findings of superficial elevated gastric lesions on conventional endoscopy with white-light imaging |
| Date of disclosure of the study information | 2014/01/22 |
| Last modified on | 2016/11/14 22:30:08 |
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Basic information
Public title
Evaluation of the endoscopic findings of superficial elevated gastric lesions on conventional endoscopy with white-light imaging
Acronym
Endoscopic diagnosis of superficial elevated gastric lesions
Scientific Title
Evaluation of the endoscopic findings of superficial elevated gastric lesions on conventional endoscopy with white-light imaging
Scientific Title:Acronym
Endoscopic diagnosis of superficial elevated gastric lesions
Region
| Japan |
Condition
Condition
early gastric carcinomas, low-grade gastric adenomas
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the useful endoscopic findings of superficial elevated-type gastric epithelial neoplasias on conventional endoscopy with white-light imaging for differential diagnosis between early carcinomas and low-grade adenomas
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The useful useful optical signs on conventional endoscopy for discriminating between early carcinomas and low-grade adenomas
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Evaluation of superficial elevated-type gastric epithelial neoplasias on conventional endoscopy with white-light imaging and chromoendoscopy
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
The superficial elevated-type gastric epithelial neoplasia which were resected by endoscopic submucosal dissection at our institution
Key exclusion criteria
Other exclusion criteria includes advanced gastric carcinoma, co-existing advanced gastric carcinomas, co-existing carcinomas of any other organs, and a past history of surgical resection of the stomach
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nonaka Takashi |
Organization
Yokohama City University Hospital
Division name
Gastroenterology Division
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL
045-787-2640
nonaka@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nonaka Takashi |
Organization
Yokohama City University Hospital
Division name
Gastroenterology Division
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL
045-787-2640
Homepage URL
nonaka@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital, Gastroenterology Division
Institute
Department
Personal name
Funding Source
Organization
The Yokohama Foundation for Advancement of Medical Science
Organization
Division
Category of Funding Organization
Non profit foundation
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
Yokohama City University Hospital
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 22 | 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
The lesion size and color may be useful optical parameters on conventional endoscopy with white-light imaging of superficial elevated-type gastric epithelial neoplasias for discriminating between early carcinomas and low-grade adenomas
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
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 22 | Day |
Last modified on
| 2016 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015114
