UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000937 |
|---|---|
| Receipt number | R000001012 |
| Scientific Title | Molecular and endoscopic surveillance of Barrett's esophagus |
| Date of disclosure of the study information | 2007/12/07 |
| Last modified on | 2013/06/15 15:43:17 |
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Basic information
Public title
Molecular and endoscopic surveillance of Barrett's esophagus
Acronym
Molecular and endoscopic surveillance of Barrett's esophagus
Scientific Title
Molecular and endoscopic surveillance of Barrett's esophagus
Scientific Title:Acronym
Molecular and endoscopic surveillance of Barrett's esophagus
Region
| Japan |
Condition
Condition
Reflux esophagitis,Barrett's esophagus
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Aim of this study is to determine the pathogenesis of reflux esophagitis and Barrett's esophagus and to examine risk factor of the development to the esophageal adenocarcinoma.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relasion between carcinogenesis of the esophageal adenocarcinoma from Barrett's esophagus and DNA methylation, a change of microRNA expression, oxidation stress marker,metabolic marker.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria is the following.
1.Patient who have atended a Keio University Hospital
2.Patient who have Reflux esophagitis or Barrett's epithelium or Barrett's esophagus
3.Patient who provide weitten informed consent
Key exclusion criteria
Exclusion criteria is the following.
1.Patient who have medical history of an upper gastrointestinal tract disease
2.Patient who have other severe diseases
3.Patient who take some anticoagulant or antiplatelet drugs and who cannnot stop it.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidekazu Suzuki, M.D., Ph.D. |
Organization
Keio University
Division name
Division of Gastroenterology,Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidekazu Suzuki |
Organization
Keio University
Division name
Division of Gastroenterology,Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
hsuzuki@sc.itc.keio.ac.jp
Sponsor or person
Institute
Division of Gastroenterology,Department of Internal Medicine, School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2007 | Year | 12 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2007 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 12 | Month | 07 | Day |
Last modified on
| 2013 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001012
