UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037414
Receipt number R000042645
Scientific Title International multicenter study on learning effect of early digestive tract cancer diagnosis for gastroenterologist in Myanmar
Date of disclosure of the study information 2019/10/01
Last modified on 2023/01/20 14:03:10

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Basic information

Public title

International multicenter study on learning effect of early digestive tract cancer diagnosis for gastroenterologist in Myanmar

Acronym

Learning effect of early digestive tract cancer diagnosis for gastroenterologist in Myanmar

Scientific Title

International multicenter study on learning effect of early digestive tract cancer diagnosis for gastroenterologist in Myanmar

Scientific Title:Acronym

Learning effect of early digestive tract cancer diagnosis for gastroenterologist in Myanmar

Region

Japan Asia(except Japan)


Condition

Condition

Early digestive tract cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Education of endoscopic diagnosis and evaluation of learning effect for gastroenterologist in Myanmar

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of early cancer detection rate before intervention and after 2 years of intervention.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

We give lectures, technical guidance and case studies on diagnosis of early cancer in Myanmar twice a year during two years.

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who are to be subjected to gastrointestinal endoscopy, those who agree with the main purpose of thisstudy.

Key exclusion criteria

Cases where patient consent can not be obtained.

Target sample size

8000


Research contact person

Name of lead principal investigator

1st name Kenshi
Middle name
Last name Yao

Organization

Fukuoka University Chikushi Hospital

Division name

Department of Endoscopy

Zip code

818-8502

Address

1-1-1 Zokumyoin, Chikushino, Fukuoka 818-8502

TEL

092-921-1011

Email

yao@fukuoka-u.ac.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Hisabe

Organization

Fukuoka University Chikushi Hospital

Division name

Department of Gastroenterology

Zip code

818-8502

Address

1-1-1 Zokumyoin, Chikushino, Fukuoka 818-8502

TEL

092-921-1011

Homepage URL


Email

hisabe@cis.fukuoka-u.ac.jp


Sponsor or person

Institute

Fukuoka University Chikushi Hospital

Institute

Department

Personal name



Funding Source

Organization

Asian Nobel Bio-Imaging and Intervention Group

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukuoka University Chikushi Hospital

Address

1-1-1 Zokumyoin, Chikushino, Fukuoka 818-8502

Tel

092-921-1011

Email

chikushirinsho@adm.fukuoka-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



Other administrative information

Date of disclosure of the study information

2019 Year 10 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

8000

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

2019 Year 06 Month 22 Day

Date of IRB

2019 Year 06 Month 12 Day

Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2022 Year 12 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

2019 Year 07 Month 18 Day

Last modified on

2023 Year 01 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042645


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name