UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013315 |
|---|---|
| Receipt number | R000015534 |
| Scientific Title | A study of the diagnosis, examination, and therapeutic strategy for gastric submucosal tumor |
| Date of disclosure of the study information | 2014/03/05 |
| Last modified on | 2020/10/02 15:37:58 |
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Basic information
Public title
A study of the diagnosis, examination, and therapeutic strategy for gastric submucosal tumor
Acronym
A study of the diagnosis, examination, and therapeutic strategy for gastric submucosal tumor
Scientific Title
A study of the diagnosis, examination, and therapeutic strategy for gastric submucosal tumor
Scientific Title:Acronym
A study of the diagnosis, examination, and therapeutic strategy for gastric submucosal tumor
Region
| Japan |
Condition
Condition
solid submucosal tumor of the stomach whose diameter is 2cm or less
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Multi-center prospective observational study for gastric submucosal tumor(SMT)
To observe the clinical course of gastric SMT and to find adequate diagnostic modality, duration of follow up, and therapeutic strategy.
Basic objectives2
Others
Basic objectives -Others
prospective observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the proportion of patients with tumor growing at greater than 5 mm per five years and per ten years, respectively
Key secondary outcomes
Clinical factor of patients with tumor growing at greater than 5 mm and time to tumor progression
The proportion of patients with growing tumor and time to tumor progression in each clinical risk factor, if the tumor is histologically diagnosed as GIST
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
1) Patients whose gastric submucosal tumors are newly diagnosed by EGD.
2) Patients whose gastric submucosal tumors were previously diagnosed by EGD and followed up or treated by resection.
3) Patients who have provided written informed consent for participation in the study
Key exclusion criteria
Patients judged unsuitable for study participation by the investigator for any other reason.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Okada |
Organization
Okayama University Hospital
Division name
Department of Endoscopy
Zip code
700-8558
Address
2-5-1 Shikata-Cho, Kita-Ku, Okayama 700-8558, Japan
TEL
0862357218
iwamuromasaya@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Tsuzuki |
Organization
Okayama University Hospital
Division name
Department of General Medicine,
Zip code
700-8558
Address
2-5-1 Shikata-Cho, Kita-Ku, Okayama 700-8558, Japan
TEL
0862357218
Homepage URL
tsuzuo@gmail.com
Sponsor or person
Institute
Japan Gastroenterological Endoscopy Society
Institute
Department
Personal name
Funding Source
Organization
Member of Japan Gastroenterological Endoscopy Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Member of Japan Gastroenterological Endoscopy Society
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
0862357218
iwamuromasaya@yahoo.co.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
| 2014 | Year | 03 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will release an interim report because this is a long-term observational study.
Management information
Registered date
| 2014 | Year | 03 | Month | 03 | Day |
Last modified on
| 2020 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015534
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
