UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the association between patients' characteristic and endoscopic evaluation, especially gastroesophageal reflex disease.
Acronym	Examination of the association between patients' characteristic and endoscopic evaluation.
Scientific Title	Examination of the association between patients' characteristic and endoscopic evaluation, especially gastroesophageal reflex disease.
Scientific Title:Acronym	Examination of the association between patients' characteristic and endoscopic evaluation.
Region	Japan

Condition
Condition	gastrointestinal disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the association between patients' characteristic and endoscopic evaluation.
Basic objectives2	Others
Basic objectives -Others	factor
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Factors that may affect endoscopic evaluations.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who received endoscopic examination in our hospital.
Key exclusion criteria	none
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Matsunaga
Organization	Saiseikai Karatsu Hospital
Division name	Divison of internal medicine
Zip code	847-0852
Address	817, motohata town, karatsu city, saga prefecture Japan
TEL	0955-73-3175
Email	mattaku0810@gmail.com

Public contact
Name of contact person	1st name Takuya Middle name Last name Matsunaga
Organization	Saiseikai Karatsu Hospital
Division name	Divison of internal medicine
Zip code	847-0852
Address	817, motohata town, karatsu city, saga prefecture Japan
TEL	0955-73-3175
Homepage URL
Email	mattaku0810@gmail.com

Sponsor
Institute	Saiseikai Karatsu Hospital
Institute
Department

Funding Source
Organization	self funding
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	Saiseikai Karatsu Hospital
Address	817, motohata town, karatsu city, saga prefecture Japan
Tel	0955-73-3175
Email	info@saiseikai-karatsu.com

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 07 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	1991
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	2017 Year 07 Month 02 Day
Date of IRB
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2018 Year 07 Month 31 Day
Date of closure to data entry	2018 Year 07 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study type:Prospective Observational Study Object:Patients who will receive endoscopic examination in Saiseikai Karatsu Hospital from 1 August 2017 until 31 July 2018.

Management information
Registered date	2017 Year 07 Month 02 Day
Last modified on	2019 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032104

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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