UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030538
Receipt number R000034865
Scientific Title Endoscopic features in patient with early gastric cancer detected after successful Helicobacter pylori eradication
Date of disclosure of the study information 2017/12/25
Last modified on 2017/12/24 01:13:35

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Basic information

Public title

Endoscopic features in patient with early gastric cancer detected after successful Helicobacter pylori eradication

Acronym

Endoscopic features in patient with early gastric cancer detected after successful Helicobacter pylori eradication

Scientific Title

Endoscopic features in patient with early gastric cancer detected after successful Helicobacter pylori eradication

Scientific Title:Acronym

Endoscopic features in patient with early gastric cancer detected after successful Helicobacter pylori eradication

Region

Japan


Condition

Condition

Gastric cancer detected after successful Helicobacter pylori eradication

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify endoscopic features in patient with early gastric cancer detected after successful Helicobacter pylori eradication.

Basic objectives2

Others

Basic objectives -Others

To clarify endoscopic features in patient with early gastric cancer detected after successful Helicobacter pylori eradication.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The frequency of endoscopic finding recognized in patients with early gastric cancer detected after successful H.pylori eradication

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

15 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent esophagogastroduodenoscopy after successful H.pylori eradication at Kyoto Prefectural University of Medicine from November 2015

Key exclusion criteria

Patients who underwent esophagogastroduodenoscopy within one year after H.pylori eradication

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuji Naito

Organization

Kyoto Prefectural University of Medicine

Division name

Gastroenterology and Hepatology

Zip code


Address

465 Kajiicho Kamigyoku Kyoto

TEL

075-251-5111

Email

ynaito@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Atsushi Majima

Organization

Kyoto Prefectural University of Medicine

Division name

Gastroenterology and Hepatology

Zip code


Address

465 Kajiicho Kamigyoku Kyoto

TEL

075-251-5111

Homepage URL


Email

a-majima@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine
Gastroenterology and Hepatology

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine
Gastroenterology and Hepatology

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

2017 Year 12 Month 25 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

Open public recruiting

Date of protocol fixation

2015 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The frequency of endoscopic finding recognized in patients with early gastric cancer detected after successful H.pylori eradication


Management information

Registered date

2017 Year 12 Month 24 Day

Last modified on

2017 Year 12 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034865


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name