UMIN-CTR Clinical Trial

Basic information
Public title	A study of the diagnosis, examination, and therapeutic strategy for gastric submucosal tumor
Acronym	A study of the diagnosis, examination, and therapeutic strategy for gastric submucosal tumor
Scientific Title	A study of the diagnosis, examination, and therapeutic strategy for gastric submucosal tumor
Scientific Title:Acronym	A study of the diagnosis, examination, and therapeutic strategy for gastric submucosal tumor
Region	Japan

Condition
Condition	solid submucosal tumor of the stomach whose diameter is 2cm or less
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Multi-center prospective observational study for gastric submucosal tumor(SMT) To observe the clinical course of gastric SMT and to find adequate diagnostic modality, duration of follow up, and therapeutic strategy.
Basic objectives2	Others
Basic objectives -Others	prospective observational study
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	the proportion of patients with tumor growing at greater than 5 mm per five years and per ten years, respectively
Key secondary outcomes	Clinical factor of patients with tumor growing at greater than 5 mm and time to tumor progression The proportion of patients with growing tumor and time to tumor progression in each clinical risk factor, if the tumor is histologically diagnosed as GIST

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	1) Patients whose gastric submucosal tumors are newly diagnosed by EGD. 2) Patients whose gastric submucosal tumors were previously diagnosed by EGD and followed up or treated by resection. 3) Patients who have provided written informed consent for participation in the study
Key exclusion criteria	Patients judged unsuitable for study participation by the investigator for any other reason.
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Okada
Organization	Okayama University Hospital
Division name	Department of Endoscopy
Zip code	700-8558
Address	2-5-1 Shikata-Cho, Kita-Ku, Okayama 700-8558, Japan
TEL	0862357218
Email	iwamuromasaya@yahoo.co.jp

Public contact
Name of contact person	1st name Takao Middle name Last name Tsuzuki
Organization	Okayama University Hospital
Division name	Department of General Medicine,
Zip code	700-8558
Address	2-5-1 Shikata-Cho, Kita-Ku, Okayama 700-8558, Japan
TEL	0862357218
Homepage URL
Email	tsuzuo@gmail.com

Sponsor
Institute	Japan Gastroenterological Endoscopy Society
Institute
Department

Funding Source
Organization	Member of Japan Gastroenterological Endoscopy Society
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Member of Japan Gastroenterological Endoscopy Society
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Okayama University Hospital
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
Tel	0862357218
Email	iwamuromasaya@yahoo.co.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	2014 Year 03 Month 05 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	Enrolling by invitation
Date of protocol fixation	2014 Year 02 Month 27 Day
Date of IRB	2014 Year 03 Month 01 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2024 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We will release an interim report because this is a long-term observational study.

Management information
Registered date	2014 Year 03 Month 03 Day
Last modified on	2020 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015534