UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042728 |
|---|---|
| Receipt number | R000048716 |
| Scientific Title | Long-Term Course of Gastric Submucosal Tumors by Tumor Size. prospective and retrospective study, observational study. |
| Date of disclosure of the study information | 2020/12/11 |
| Last modified on | 2023/08/07 14:27:20 |
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Basic information
Public title
Long-Term Course of Gastric Submucosal Tumors by Tumor Size: Time to Growth and Risk Factors
Acronym
Long-Term Course of Gastric Submucosal Tumors by Tumor Size
Scientific Title
Long-Term Course of Gastric Submucosal Tumors by Tumor Size. prospective and retrospective study, observational study.
Scientific Title:Acronym
Long-Term Course of Gastric Submucosal Tumors by Tumor Size
Region
| Japan |
Condition
Condition
Gastric submucosal tumors
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the long-term course of gastric mesenchymal tumors (GMTs), and clarify the factors affected by the size increase and growth speed of the tumors.
Basic objectives2
Others
Basic objectives -Others
Natural course
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
size increase of gastric SMT
Key secondary outcomes
the factors affected by the size increase and growth speed of the tumors
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
SMT cases in which endoscopic ultrasonography is performed
Key exclusion criteria
none
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Matsumura |
Organization
Chiba university
Division name
gastroenterology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku,Chiba-shi,Chiba
TEL
043-222-7171
matsumura@chiba-u.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Shiratori |
Organization
Chiba university
Division name
gastroenterology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku,Chiba-shi,Chiba
TEL
043-222-7171
Homepage URL
shiratori.wataru@chiba-u.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
Chiba university
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
Chiba university
Address
1-8-1 Inohana, Chuo-ku,Chiba-shi,Chiba
Tel
043-222-7171
shiratori.wataru@chiba-u.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective and retrospective study
Management information
Registered date
| 2020 | Year | 12 | Month | 11 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048716
