UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013664
Receipt number R000015944
Scientific Title The usefulness of a novel atrophic gastritis diagnosis method by gastric X-ray examination -comparison to gastric ABC screening-
Date of disclosure of the study information 2014/04/10
Last modified on 2015/05/08 22:03:33

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Basic information

Public title

The usefulness of a novel atrophic gastritis diagnosis method by gastric X-ray examination -comparison to gastric ABC screening-

Acronym

A novel atrophic gastritis diagnosis method

Scientific Title

The usefulness of a novel atrophic gastritis diagnosis method by gastric X-ray examination -comparison to gastric ABC screening-

Scientific Title:Acronym

A novel atrophic gastritis diagnosis method

Region

Japan


Condition

Condition

Atrophic gastritis
Infectious gastritis of Helicobacter pylori

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison between our original atrophic gastritis diagnosis method and ABC screening

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sensitivity and specificity of atrophic gastritis diagnosis method

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

All patiants of screening for gastric disease

Key exclusion criteria

Patiants who use antibiotic drug to treat infectious gastritis of Helicobacter pylori

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noritsugu Ohashi

Organization

Ichinomiya Nishi Hospital

Division name

Department of gastroenterology

Zip code


Address

1 Hira Kaimei Ichinomiya Aichi Japan

TEL

0586-48-0077

Email

ichinishi084@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noritsugu Ohashi

Organization

Ichinomiya Nishi Hospital

Division name

Depatement of gastroenterology

Zip code


Address

1 Hira Kaimei Ichinomiya Aichi Japan

TEL

0586-48-0077

Homepage URL


Email

ichinishi084@yahoo.co.jp


Sponsor or person

Institute

Ichinomiya Nishi Hospital

Institute

Department

Personal name



Funding Source

Organization

Ichinomiya Nishi Hospital

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

2014 Year 04 Month 10 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

2014 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 04 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective study


Management information

Registered date

2014 Year 04 Month 07 Day

Last modified on

2015 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015944


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name