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 UMIN000035344
Receipt No. R000040268
Scientific Title Establishment of Endoscopic Duodenal Observational Protocol on Duodenal Lesion Detection During Screening Esophagogastroduodenoscopy
Date of disclosure of the study information 2019/01/04
Last modified on 2018/12/22

* 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 Establishment of Endoscopic Duodenal Observational Protocol on Duodenal Lesion Detection During Screening Esophagogastroduodenoscopy
Acronym Endoscopic Duodenal Observational Protocol
Scientific Title Establishment of Endoscopic Duodenal Observational Protocol on Duodenal Lesion Detection During Screening Esophagogastroduodenoscopy
Scientific Title:Acronym Endoscopic Duodenal Observational Protocol
Region
Japan

Condition
Condition Duodenal Lesion
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To propose endoscopic duodenal observational protocol on duodenal lesion detection
Basic objectives2 Others
Basic objectives -Others To investigate the incidental rate of duodenal lesion by the observational protocol
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Phase I

Assessment
Primary outcomes The completion rate of established observational protocol
Key secondary outcomes 1.The incidental rate of duodenal lesion
2.The incidental rate of duodenal meoplasms which need treatment
3.The examination time of duodenum
4.Total examination time

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who undergo screening esophagogastroduodenoscopy
Key exclusion criteria 1)without informed consent
2)already detected duodenal neoplasm
3)past history of upper GI surgery
4)severe mental status
5)inproper indication judged by doctor
Target sample size 4000

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hideki Kobara
Organization Faculty of Medicine, Kagawa University
Division name Gastroenterology and Neurology
Zip code
Address 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL 0878985111
Email kobara@med.kagawa-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yasuoka
Organization Faculty of Medicine, Kagawa University
Division name Investigator
Zip code
Address 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL 0878985111
Homepage URL
Email kobara@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa University
Institute
Department

Funding Source
Organization Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor KKR hospital Mitsugu Yasuda
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
2019 Year 01 Month 04 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
2018 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2019 Year 03 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 none

Management information
Registered date
2018 Year 12 Month 22 Day
Last modified on
2018 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040268

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.