UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017994
Receipt number 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 18:35:36

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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 or person

Institute

Division of Gastroenterology, Hyogo College of Medicine

Institute

Department

Personal name



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

Value
https://center6.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