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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017994
Receipt No. R000020853
Scientific Title Localization of specialized intestinal metaplasia and the molecular alterations in Barrett's esophagus in a Japanese population: an analysis of biopsy samples based on the "Seattle" biopsy protocol
Date of disclosure of the study information 2015/06/21
Last modified on 2015/12/25

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Basic information
Public title Localization of specialized intestinal metaplasia and the molecular alterations in Barrett's esophagus in a Japanese population: an analysis of biopsy samples based on the "Seattle" biopsy protocol
Acronym Phenotypic and molecular localization of BE
Scientific Title Localization of specialized intestinal metaplasia and the molecular alterations in Barrett's esophagus in a Japanese population: an analysis of biopsy samples based on the "Seattle" biopsy protocol
Scientific Title:Acronym Phenotypic and molecular localization of BE
Region
Japan

Condition
Condition Barrett's esophagus
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarify the differences of molecular alterations using four-quadrant biopsies from Barrett's esophagus (BE) based on the "Seattle" biopsy protocol
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate the differences of molecular alterations related to carcinogenesis using four-quadrant biopsies based on the "Seattle" biopsy protocol
Key secondary outcomes To investigate the differences of molecular alterations related to carcinogenesis between specialized intestinal metaplasia and columnar lined epithelium in Barrett's esophagus (BE)

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with Barrett's esophagus with more than 1 cm in diameter by endoscopy
Key exclusion criteria (1) Patients with a history of esophagectomy or gastrectomy
(2) Patients having no application to the guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment from Japan Gastroenterological Endoscopy Society
(3) Patients who have determined by the physicians to have any reasons of unqualified
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jiro Watari
Organization Hyogo College of Medicine
Division name Division of Gastroenterology
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya 663-8501, Japan
TEL 0798-45-6662
Email watarij@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jiro Watari
Organization Hyogo College of Medicine
Division name Division of Gastroenterology
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya 663-8501, Japan
TEL 0798-45-6662
Homepage URL
Email watarij@hyo-med.ac.jp

Sponsor
Institute Division of Gastroenterology, Hyogo College of Medicine
Institute
Department

Funding Source
Organization None
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
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
2015 Year 06 Month 21 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
1. MSI and hypermethylation at RUNX3, MGMT, hMLH1, p16 and APC genes were associated with BE carcinogenesis, but only APC gene hypermethylation was an independent predictive marker of EAC (OR=24.4, p=0.01) in the multivariate logistic regression analysis. In addition, the incidence of the these biomarkers did not show a significant difference between the 0-3 o'clock and 6-9 o'clock areas. 
2. SIM was more frequently identified in the 0-3 o'clock quadrant than in the 6-9 o'clock quadrant (p=0.08). 
3. The Ki-67 index was higher in SIM than in the columnar-lined epithelium (CLE) without goblet cells (p<0.0001), and in both SIM and CLE with Das-1 reactivity than in those without (p=0.04 and p=0.06, respectively).
4. The Ki-67 index was relatively higher in the 0-3 o'clock quadrant than in the 6-9 o'clock quadrant in cases with Das-1 reactivity.



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
2014 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2015 Year 04 Month 30 Day
Date analysis concluded
2015 Year 08 Month 31 Day

Other
Other related information 1. RUNX3 methylation and Das-1 reactivity were more frequently found in SIM than in CLE (p=0.04 and p<0.0001, respectively).

Management information
Registered date
2015 Year 06 Month 21 Day
Last modified on
2015 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020853

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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