UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034638 |
|---|---|
| Receipt number | R000039488 |
| Scientific Title | Multicenter retrospective study of the relationship between Barrett's esophagus and colonic diseases |
| Date of disclosure of the study information | 2018/10/31 |
| Last modified on | 2020/04/26 09:56:48 |
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Basic information
Public title
Multicenter retrospective study of the relationship between Barrett's esophagus and colonic diseases
Acronym
The relationship between Barrett's esophagus and colonic diseases
Scientific Title
Multicenter retrospective study of the relationship between Barrett's esophagus and colonic diseases
Scientific Title:Acronym
The relationship between Barrett's esophagus and colonic diseases
Region
| Japan |
Condition
Condition
Barrett's esophagus
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the risk factor of Barrett's esophagus, the relationship between Barrett's esophagus and colonic diseases is investigated.
Basic objectives2
Others
Basic objectives -Others
Establishment of a new strategy of the clinical management of Barrett's esophagus.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of the combination of Barrett's esophagus and colonic diseases
Key secondary outcomes
The relationship between reflux esophagitis and colonic dideases and recent prevalence of Barrett's esophagus.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In the enrolled 3 institutions, from January 2012 to December 2017, patients who received both EGD and colonoscopy during 6 months.
Key exclusion criteria
Post-colectomy, post-esophagotomy, post-total and post-proximal gastrectomy
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Amano |
Organization
New Tokyo Hospital
Division name
Endoscopy
Zip code
270-2232
Address
1271 Wanagaya, Matsudo city, Chiba
TEL
047-711-8700
y-amano@shin-tokyohospital.or.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Amano |
Organization
New Tokyo Hospital
Division name
Endoscopy
Zip code
270-2232
Address
1271 Wanagaya, Matsudo city, Chiba
TEL
047-711-8700
Homepage URL
y-amano@shin-tokyohospital.or.jp
Sponsor or person
Institute
Division of Endoscopy, New Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
self finding
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
New Tokyo Hospital
Address
1271 Wanagaya, Matsudo, Chiba, Japan
Tel
047-711-8700
y-amano@shin-tokyohospital.or.jp
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
| 2018 | Year | 10 | Month | 31 | 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
Main results already published
Date of protocol fixation
| 2018 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 04 | Month | 30 | Day |
Other
Other related information
The entry will be started after the IRB approval in other enrolled institutions.
Management information
Registered date
| 2018 | Year | 10 | Month | 25 | Day |
Last modified on
| 2020 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039488
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
