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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041795
Receipt No. R000047703
Scientific Title Endoscopic resection for gastric submucosal tumor
Date of disclosure of the study information 2020/09/15
Last modified on 2020/09/15

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Basic information
Public title Endoscopic resection for gastric submucosal tumor
Acronym ER for gastric SMT
Scientific Title Endoscopic resection for gastric submucosal tumor
Scientific Title:Acronym ER for gastric SMT
Region
Japan

Condition
Condition gastric submucosal tumor
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of endoscopic resection for gastric submucosal tumor
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes En block resection rate by endoscopy
Key secondary outcomes Pathological complete resection rate, endoscopic procedure complete resection rate, adverse event, procedure time, comparison of preoperative diagnosis and pathological diagnosis, overall survival at five years, and disease specific survival at five years

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Endoscopic resection
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

Not applicable
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) 11-30mm by EUS and CT
2) intraluminal type
Key exclusion criteria 1) epithelial tumor
2) ulcerative finding by endoscopy
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Noriya
Middle name
Last name Uedo
Organization Osaka International Cancer Institute
Division name Department of Gastrointestinal Oncology
Zip code 5418567
Address 3-1-69, Otemae, Chuo-ku, Osaka, Japan
TEL 0669451181
Email noriya.uedo@oici.jp

Public contact
Name of contact person
1st name Satoki
Middle name
Last name Shichijo
Organization Osaka International Cancer Institute
Division name Department of Gastrointestinal Oncology
Zip code 5418567
Address 3-1-69, Otemae, Chuo-ku, Osaka, Japan
TEL 0669451181
Homepage URL
Email 7satoki@oici.jp

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization N/A
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 Osaka International Cancer Institute
Address 3-1-69, Otemae, Chuo-ku, Osaka, Japan
Tel 0669451181
Email rinri01@opho.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 杏林大学医学部、静岡がんセンター、神戸大学医学部附属病院 国際がん医療・研究センター、横浜市立大学附属市民総合医療センター、大阪国際がんセンター

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 15 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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 09 Day
Date of IRB
2020 Year 08 Month 15 Day
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2028 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 15 Day
Last modified on
2020 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047703

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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