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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016555
Receipt No. R000019212
Scientific Title 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
Date of disclosure of the study information 2015/02/20
Last modified on 2016/05/12

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Basic information
Public title 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
Acronym Preoperative risk classification of GIST by EUS-FNA
Scientific Title 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
Scientific Title:Acronym 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

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 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
1st name
Middle name
Last name Ichiro Yasuda
Organization Teikyo University Mizonokuchi Hospital
Division name Department of Gastroenterology
Zip code
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
1st name
Middle name
Last name Ichiro Yasuda
Organization Teikyo University Mizonokuchi Hospital
Division name Department of Gastroenterology
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2014 Year 01 Month 30 Day
Date of IRB
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

Other
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

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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