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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003045
Receipt No. R000003338
Scientific Title Chromoendoscopy in diagnosis of gastric intestinal metaplasia: a muticenter prospecive randomized control trial
Date of disclosure of the study information 2010/02/01
Last modified on 2012/05/11

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Basic information
Public title Chromoendoscopy in diagnosis of gastric intestinal metaplasia: a muticenter prospecive randomized control trial
Acronym IM-chromo study
Scientific Title Chromoendoscopy in diagnosis of gastric intestinal metaplasia: a muticenter prospecive randomized control trial
Scientific Title:Acronym IM-chromo study
Region
Japan

Condition
Condition Gastric intestinal metaplasia
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate usefulness of choromoedoscopy in diagnosis of gastric intestinal metaplasia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic accuracy for intestinal metaplasia
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine Maneuver
Interventions/Control_1 Chromoendoscopy with indigo carmine
Interventions/Control_2 Conventional 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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients require esophago-gastro-duodenoscopy and gave written informed consent
Key exclusion criteria Patients who are suspicious of advanced malignancy, having symptoms of acute gastrointestinal hemorrhage, history of H. pylori eradication, diagnosed as having intestinal metaplasia, gastrectomy, NSAIDS, anticoaglants and antiplatelet aggregation agents with in one week, severe organ failure, pregnancy
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriya Uedo
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
Address 1-3-3, Nakamichi, Higashinari-ku, Osaka
TEL 06-6972-1181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noriya Uedo
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
Address
TEL
Homepage URL
Email uedou-no@mc.pref.osaka.jp

Sponsor
Institute Asahi University, Murakami Memorial Hospital
Institute
Department

Funding Source
Organization Japan Gastroenterological Endoscopy Society
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2010 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2010 Year 06 Month 01 Day
Date trial data considered complete
2010 Year 09 Month 01 Day
Date analysis concluded
2010 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 16 Day
Last modified on
2012 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003338

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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