UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013621
Receipt number R000015904
Scientific Title Comparative study for evaluation of endoscopic screening for gastric cancer
Date of disclosure of the study information 2014/04/03
Last modified on 2019/10/09 15:08:03

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Basic information

Public title

Comparative study for evaluation of endoscopic screening for gastric cancer

Acronym

Evaluation study of endoscopic screening for gastric cancer

Scientific Title

Comparative study for evaluation of endoscopic screening for gastric cancer

Scientific Title:Acronym

Evaluation study of endoscopic screening for gastric cancer

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of mortality reduction from gastric cancer by endoscopic screening

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Mortality of gastric cancer

Key secondary outcomes

1) All causes mortality/Mortality of all cancers
2) Incidence of gastric cancer
3) Sensitivity/Specificity
4) Rates of adverse effects
5) Cost-effectiveness ratio


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Upper gastrointestinal endoscopy
Helicobacter pylori antibody
Pepsinogen

Interventions/Control_2

No intervention

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

61 years-old <=

Age-upper limit

61 years-old >=

Gender

Male and Female

Key inclusion criteria

1) 61 years at first screening year for intervention
2) Inhabitants who have lived in Niigata city for more than 3 years before the first screening for intervention

Key exclusion criteria

1) Any cancer patients
2) Individuals who have participated in gastric cancer screening in Niigata city within 2 years
3) Patient who have been in therapy for any gastric diseases
4) Patients who have any serious disease and have excluded from target of endoscopic screening for gastric cancer

Target sample size

6000


Research contact person

Name of lead principal investigator

1st name Chisato
Middle name
Last name Hamashima

Organization

Teikyo University

Division name

Faculty of Medical Technology

Zip code

173-8606

Address

2-11-1 Kaga Itabashi-ku, Tokyo

TEL

03-3964-1211

Email

chamashi@med.teikyo-u.ac.jp


Public contact

Name of contact person

1st name Chisato
Middle name
Last name Hamashima

Organization

Niigata City Medical Association

Division name

Office of Research for Endoscopic Screening

Zip code

9500914

Address

3-3-11, Shichikuyama, Chuo-ku, Niigata-shi, Niigata

TEL

025-247-8900

Homepage URL

http://www.esgcr.jp/

Email

kenshin@esgcr.jp


Sponsor or person

Institute

Japan Agency for Medical Reaserch and DEvelopment

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Reaserch and DEvelopment

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Niigata City Health Community Center
Niigata City Medical Association

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Teikyo University

Address

2-11-1 Kaga Itabashi-ku, Tokyo

Tel

0339641211

Email

turb-office@teikyo-u.ac.jp


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

新潟市医師会による内視鏡検診実施認定施設(新潟市)


Other administrative information

Date of disclosure of the study information

2014 Year 04 Month 03 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

No longer recruiting

Date of protocol fixation

2012 Year 05 Month 29 Day

Date of IRB

2012 Year 05 Month 16 Day

Anticipated trial start date

2012 Year 05 Month 29 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 04 Month 03 Day

Last modified on

2019 Year 10 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015904


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name