UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A retrospective cohort study to evaluate the accuracy of preoperative risk classification of gastrointestinal stromal tumor by endoscopic ultrasound-guided fine needle aspiration biopsy using a 19 gauge needle
Title of the study (Brief title)	Preoperative risk classification of GIST by EUS-FNA
Region	Japan

Condition
Condition	GIST
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the accuracy of preoperative risk classification of gastrointestinal stromal tumor by endoscopic ultrasound-guided fine needle aspiration biopsy using a 19 gauge needle
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Co-efficiency of the recurrence risk classification of GIST between EUS-FNA samples and resected specimens
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with submucosal lesion of stomach which was judged we can perform EUS-FNA
Key exclusion criteria	1)Age below 20 years 2) Patients with bleeding tendency 3) Patients whose informed consent could not be obtained. 4)In case that doctors judged inappropriate for the entry
Target sample size	70

Research contact person
Name of lead principal investigator	Ichiro Yasuda
Organization	Teikyo University Mizonokuchi Hospital
Division name	Department of Gastroenterology
Address	3-8-3 Mizonokuchi, Takatsu-ku, Kawasaki, 213-8507, Japan
TEL	+81-44-844-3333
Email	YASUDAIC@aol.com

Public contact
Name of contact person	Ichiro Yasuda
Organization	Teikyo University Mizonokuchi Hospital
Division name	Department of Gastroenterology
Address	3-8-3 Mizonokuchi, Takatsu-ku, Kawasaki, 213-8507, Japan
TEL	+81-44-844-3333
Homepage URL
Email	YASUDAIC@aol.com

Sponsor
Institute	19 gauge EUS-FNA for GSMT group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

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	2015 Year 02 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 30 Day
Anticipated trial start date	2014 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We can exactly predict the recurrence risk of GISTs before surgical therapy.

Management information
Registered date	2015 Year 02 Month 16 Day
Last modified on	2016 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019212