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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034638
Receipt No. 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 2019/10/28

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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
Email 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
Email y-amano@shin-tokyohospital.or.jp

Sponsor
Institute Division of Endoscopy, New Tokyo Hospital
Institute
Department

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
Email 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 Preinitiation
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
2019 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039488

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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