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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007428
Receipt No. R000008753
Scientific Title Diagnostic efficacy of ultrasound endoscopy for submucosal tumor of the stomach
Date of disclosure of the study information 2012/03/02
Last modified on 2013/01/20

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Basic information
Public title Diagnostic efficacy of ultrasound endoscopy for submucosal tumor of the stomach
Acronym Diagnostic efficacy of ultrasound endoscopy for submucosal tumor of the stomach
Scientific Title Diagnostic efficacy of ultrasound endoscopy for submucosal tumor of the stomach
Scientific Title:Acronym Diagnostic efficacy of ultrasound endoscopy for submucosal tumor of the stomach
Region
Japan

Condition
Condition submucosal tumor of the stomach
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to estimate diagnostic efficacy of ultrasound endoscopy for the submucosal tumor of the stomach.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sensitivity, specificity and incidence of complication
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Biopsy with ultrasound endoscopy and fine needle aspiration biopsy
Interventions/Control_2 Biopsy with ultrasound endoscopy and without fine needle aspiration biopsy
Interventions/Control_3 Biopsy without ultrasound endoscopy and with fine needle aspiration biopsy
Interventions/Control_4 Biopsy without ultrasound endoscopy and fine needle aspiration biopsy
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) gastric submucosal tumor diagnosed by endoscopic examination
(2) clinical solitary tumor
(3) no prior treatment
(4) age 20-80 years
(5) sufficient organ function
Key exclusion criteria (1) synchronous or metachronous malignancy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Ito, MD, PhD
Organization Showa University Nothern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.
TEL
Homepage URL
Email

Sponsor
Institute Showa University Northern Yokohama Hospital
Institute
Department

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

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
2012 Year 03 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

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
2011 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 02 Day
Last modified on
2013 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008753

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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