UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043874 |
|---|---|
| Receipt number | R000050088 |
| Scientific Title | The natural history of small gastric subepithelial lesion less than 2cm |
| Date of disclosure of the study information | 2021/04/10 |
| Last modified on | 2021/04/09 01:23:33 |
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Basic information
Public title
The natural history of small gastric subepithelial lesion less than 2cm
Acronym
A study on the natural history of small gastric subepithelial lesion less than 2cm
Scientific Title
The natural history of small gastric subepithelial lesion less than 2cm
Scientific Title:Acronym
A study on the natural history of small gastric subepithelial lesion less than 2cm
Region
| Japan |
Condition
Condition
gastric subepithelial lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine The natural history of small gastric subepithelial lesion less than 2cm
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to examine The natural history of GIST
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of growth (increasing size) in small gastric subepithelial lesion less than 2cm
Key secondary outcomes
The time required for growth regardless of the pathological diagnosis of SELs
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
The small gastric SEL case with 20 mm or less that could be followed up for more than 1 year
Key exclusion criteria
Detailed information including endoscopic findings could not be obtained were excluded
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Keiichiro |
| Middle name | |
| Last name | Abe |
Organization
Dokkyo medical university
Division name
Department of Gastroenterology
Zip code
3210293
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
TEL
0282861111
abebe0319@gmail.com
Public contact
Name of contact person
| 1st name | Keiichiro |
| Middle name | |
| Last name | Abe |
Organization
Dokkyo medical university
Division name
Department of Gastroenterology
Zip code
3210293
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
TEL
0282861111
Homepage URL
abebe0319@gmail.com
Sponsor or person
Institute
Dokkyo medical university
Institute
Department
Personal name
Funding Source
Organization
none
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
Dokkyo medical university
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
Tel
0282861111
abebe0319@gmail.com
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
| 2021 | Year | 04 | Month | 10 | 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
824
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
| 2000 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2000 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A multicenter retrospective observational study
Management information
Registered date
| 2021 | Year | 04 | Month | 09 | Day |
Last modified on
| 2021 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050088
