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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014377
Receipt No. R000016739
Scientific Title A prospective study of usefulness of acetic acid-indigocarmine mixture for diagnosis of horizontal margin of gastric mucosal tumors just before ESD
Date of disclosure of the study information 2014/06/25
Last modified on 2015/07/13

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Basic information
Public title A prospective study of usefulness of acetic acid-indigocarmine mixture for diagnosis of horizontal margin of gastric mucosal tumors just before ESD
Acronym A prospective study of AIM for diagnosis of horizontal margin of gastric tumors just before ESD.
Scientific Title A prospective study of usefulness of acetic acid-indigocarmine mixture for diagnosis of horizontal margin of gastric mucosal tumors just before ESD
Scientific Title:Acronym A prospective study of AIM for diagnosis of horizontal margin of gastric tumors just before ESD.
Region
Japan

Condition
Condition gastric mucosal tumors
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To prove the usefulness of AIM for diagnosis of horizontal margin of gastric mucosal tumors just before ESD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The correspondence of horizontal margin of gastric mucosal tumores diagnosed by AIM spraying with by pathological examination.
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients whose gastric mucosal neoplasms will be treated by ESD in our hospital and who agree to the study.
Key exclusion criteria The patients who do not agree to the study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoyoshi Izumi
Organization Machida municipal hospital
Division name department of Gastroenterology
Zip code
Address 2-15-41, Asahi-machi, Machida-city, Tokyo
TEL 042-722-2230
Email m.izumi@machida-city-hp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Emiko Tanida
Organization Machida municipal hospital
Division name department of Gastroenterology
Zip code
Address 2-15-41, Asahi-machi, Machida-city, Tokyo
TEL 042-722-2230
Homepage URL
Email e.tanida@machida-city-hp.jp

Sponsor
Institute Machida municipal hospital
Institute
Department

Funding Source
Organization none
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
2014 Year 06 Month 25 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
2014 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 20 Day
Last follow-up date
2015 Year 05 Month 30 Day
Date of closure to data entry
2015 Year 05 Month 30 Day
Date trial data considered complete
2015 Year 09 Month 30 Day
Date analysis concluded
2015 Year 09 Month 30 Day

Other
Other related information During analysis

Management information
Registered date
2014 Year 06 Month 25 Day
Last modified on
2015 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016739

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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