UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007641 |
|---|---|
| Receipt number | R000008961 |
| Scientific Title | Comparison of diagnostic ability of endoscopic observational methods about demarcation of early gastirc cancers |
| Date of disclosure of the study information | 2012/04/02 |
| Last modified on | 2015/10/05 15:52:31 |
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Basic information
Public title
Comparison of diagnostic ability of endoscopic observational methods about demarcation of early gastirc cancers
Acronym
Diagnosis of demarcation of early gastric cancers
Scientific Title
Comparison of diagnostic ability of endoscopic observational methods about demarcation of early gastirc cancers
Scientific Title:Acronym
Diagnosis of demarcation of early gastric cancers
Region
| Japan |
Condition
Condition
early garic cancer
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare diagnostic ability of magnifying endoscopy with narrow band imaging and chromoendoscopy with indigocarmine about demarcation of early gastric cancers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of accurate diagnosis of demarcation of early gastric cancers
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Maneuver |
Interventions/Control_1
marking dots for demarcation of tumors
Interventions/Control_2
marking dots for demarcation of tumors
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients of early gastric cancer who will undergo endoscopic submucosal dissection at our hospital and gave written informed consent
Key exclusion criteria
patients of type 0-I cancer
patients whose cancers locate at the
greater curvature of gastric body
patients of residual cancers after
endoscopic resection
patients whose cancer was resected in
a piecemeal fashion
patients of gastric tube or post-
gastrectomy
cancers whose diameter is less than 10 mm
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Kodashima |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
kodashima-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Itsuko Asada-Hirayama |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
ihirayama-tky@umin.ac.jp
Sponsor or person
Institute
the Department of Gastroenterology, Graduate School
of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Laboratory 108, the Department of Gastroenterology
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
| 2012 | Year | 04 | Month | 02 | 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
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 02 | Day |
Last modified on
| 2015 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008961
