UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007428 |
|---|---|
| Receipt number | 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 14:56:54 |
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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
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
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008753
