UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030748
Receipt number R000033966
Scientific Title The risk factors for Barrett's esophagus: A retrospective longitudinal study of an asymptomatic Japanese adults
Date of disclosure of the study information 2018/03/01
Last modified on 2018/09/03 16:08:51

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Basic information

Public title

The risk factors for Barrett's esophagus: A retrospective longitudinal study of an asymptomatic Japanese adults

Acronym

Risk factors for Barrett's esophagus

Scientific Title

The risk factors for Barrett's esophagus: A retrospective longitudinal study of an asymptomatic Japanese adults

Scientific Title:Acronym

Risk factors for Barrett's esophagus

Region

Japan


Condition

Condition

Barrett's esophagus

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the risk factors for Barrett's esophagus in a longitudinal cohort study.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

The impact of various factors, including life style factors, Helicobacter pylori, and central obesity, on the incidence of Barrett's esophagus.

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

We conducted a retrospective longitudinal study of a large number of Japanese adults, who underwent screening endoscopy twice (first endoscopy between 2007 and 2011 and second endoscopy between 2012 and 2016; mean interval was 60 months). All subjects visited our institute for participating in a comprehensive health-checkup program, including VAT/SAT evaluation by CT.

Key exclusion criteria

Subjects taking medications for gastroesophageal reflux symptoms, gastric/duodenal ulcers, or malignant diseases were excluded from the study. Subjects diagnosed as Barrett's esophagus or gastric/esophageal cancer at the time of first endoscopy were also excluded.

Target sample size

5000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiaki GUNJI

Organization

NTT Medical Center Tokyo

Division name

Center for Preventive Medicine

Zip code


Address

higashigotanda 5-9-22, shinagawa-ku, Tokyo, Japan

TEL

03-3448-6275

Email

tgunji-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiaki GUNJI

Organization

NTT Medical Center Tokyo

Division name

Center for Preventive Medicine

Zip code


Address

higashigotanda 5-9-22, shinagawa-ku, Tokyo, Japan

TEL

03-3448-6275

Homepage URL


Email

tgunji-tky@umin.ac.jp


Sponsor or person

Institute

NTT Medical Center Tokyo

Institute

Department

Personal name



Funding Source

Organization

NTT

Organization

Division

Category of Funding Organization

Profit organization

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

2018 Year 03 Month 01 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

Completed

Date of protocol fixation

2017 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date

2018 Year 09 Month 02 Day

Date of closure to data entry

2018 Year 09 Month 02 Day

Date trial data considered complete

2018 Year 09 Month 02 Day

Date analysis concluded

2018 Year 10 Month 01 Day


Other

Other related information

The final results will be open on academic paper.


Management information

Registered date

2018 Year 01 Month 10 Day

Last modified on

2018 Year 09 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033966


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name