UMIN-CTR Clinical Trial

Basic information
Public title	The exploratory clinical study of differential diagnosis of gastric submucosal tumor using circularity
Acronym	The study of diagnosis of gastric submucosal tumor using circularity
Scientific Title	The exploratory clinical study of differential diagnosis of gastric submucosal tumor using circularity
Scientific Title:Acronym	The study of diagnosis of gastric submucosal tumor using circularity
Region	Japan

Condition
Condition	Gastric submucosal tumours with a size of 1cm to 5cm
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether the circularity of the tumor measured using EUS still images is useful for the differential diagnosis of gastric submucosal tumors.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between tumor circularity in EUS still images and pathological diagnosis.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	GIMT (GIST, leiomyoma, schwannoma)are suspected and the three following conditions are satisfied. 1) The age of registration date is 20 years or older. 2) Performance status (PS) is 0-1 according to the ECOG standard. 3) Participants have given written consent to participate in the research.
Key exclusion criteria	1) Patients with a tendency to bleed. 2) Patients with liver cirrhosis corresponding to Child-Pugh score B-C. 3) Those with chronic renal failure during maintenance dialysis. 4) Those judged to be inappropriate for participation in this study by the attending physician.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Osamu Middle name Last name Goto
Organization	Nippon Medical School
Division name	Department of Gastroenterology
Zip code	113-8603
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL	03-3822-2131
Email	o-goto@nms.ac.jp

Public contact
Name of contact person	1st name Osamu Middle name Last name Goto
Organization	Nippon Medical School
Division name	Department of Gastroenterology
Zip code	113-8603
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL	03-3822-2131
Homepage URL
Email	o-goto@nms.ac.jp

Sponsor
Institute	Nippon Medical School
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	Nippon Medical School
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
Tel	03-3822-2131
Email	nms_fuzokurinri@nms.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	2021 Year 03 Month 08 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	Open public recruiting
Date of protocol fixation	2020 Year 11 Month 20 Day
Date of IRB	2020 Year 11 Month 30 Day
Anticipated trial start date	2021 Year 03 Month 09 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The purpose of this study is to prospectively investigate whether the circularity of the tumor measured using EUS still images is useful for the differential diagnosis of gastric submucosal tumors. For pathological diagnosis of tumor, tissue obtained by boring biopsy, EUS-FNA, mucosal incision biopsy, or surgery is used.

Management information
Registered date	2021 Year 03 Month 08 Day
Last modified on	2021 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049735