UMIN-CTR Clinical Trial

Basic information
Public title	The natural history of small gastric subepithelial lesion less than 2cm
Acronym	A study on the natural history of small gastric subepithelial lesion less than 2cm
Scientific Title	The natural history of small gastric subepithelial lesion less than 2cm
Scientific Title:Acronym	A study on the natural history of small gastric subepithelial lesion less than 2cm
Region	Japan

Condition
Condition	gastric subepithelial lesion
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine The natural history of small gastric subepithelial lesion less than 2cm
Basic objectives2	Others
Basic objectives -Others	The purpose of this study is to examine The natural history of GIST
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of growth (increasing size) in small gastric subepithelial lesion less than 2cm
Key secondary outcomes	The time required for growth regardless of the pathological diagnosis of SELs

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	The small gastric SEL case with 20 mm or less that could be followed up for more than 1 year
Key exclusion criteria	Detailed information including endoscopic findings could not be obtained were excluded
Target sample size	900

Research contact person
Name of lead principal investigator	1st name Keiichiro Middle name Last name Abe
Organization	Dokkyo medical university
Division name	Department of Gastroenterology
Zip code	3210293
Address	880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
TEL	0282861111
Email	abebe0319@gmail.com

Public contact
Name of contact person	1st name Keiichiro Middle name Last name Abe
Organization	Dokkyo medical university
Division name	Department of Gastroenterology
Zip code	3210293
Address	880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
TEL	0282861111
Homepage URL
Email	abebe0319@gmail.com

Sponsor
Institute	Dokkyo medical university
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Dokkyo medical university
Address	880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
Tel	0282861111
Email	abebe0319@gmail.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	2021 Year 04 Month 10 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	824
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	2000 Year 04 Month 01 Day
Date of IRB	2020 Year 08 Month 23 Day
Anticipated trial start date	2000 Year 04 Month 01 Day
Last follow-up date	2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A multicenter retrospective observational study

Management information
Registered date	2021 Year 04 Month 09 Day
Last modified on	2021 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050088