UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003045 |
|---|---|
| Receipt number | 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 09:07:04 |
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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
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
uedou-no@mc.pref.osaka.jp
Sponsor or person
Institute
Asahi University, Murakami Memorial Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003338
