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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007641
Receipt No. 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

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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
Email 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
Email ihirayama-tky@umin.ac.jp

Sponsor
Institute the Department of Gastroenterology, Graduate School
of Medicine, The University of Tokyo
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008961

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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