UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037414
Receipt No. 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 2019/07/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Fukuoka University Chikushi Hospital
Institute
Department

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
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 Preinitiation
Date of protocol fixation
2019 Year 06 Month 22 Day
Date of IRB
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
2019 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.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


Contact us.