UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043550 |
|---|---|
| Receipt number | R000049735 |
| Scientific Title | The exploratory clinical study of differential diagnosis of gastric submucosal tumor using circularity |
| Date of disclosure of the study information | 2021/03/08 |
| Last modified on | 2021/09/24 19:28:26 |
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Basic information
Public title
The exploratory clinical study of differential diagnosis of gastric submucosal tumor using circularity
Acronym
The study of diagnosis of gastric submucosal tumor using circularity
Scientific Title
The exploratory clinical study of differential diagnosis of gastric submucosal tumor using circularity
Scientific Title:Acronym
The study of diagnosis of gastric submucosal tumor using circularity
Region
| Japan |
Condition
Condition
Gastric submucosal tumours with a size of 1cm to 5cm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the circularity of the tumor measured using EUS still images is useful for the differential diagnosis of gastric submucosal tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between tumor circularity in EUS still images and pathological diagnosis.
Key secondary outcomes
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
GIMT (GIST, leiomyoma, schwannoma)are suspected and the three following conditions are satisfied.
1) The age of registration date is 20 years or older.
2) Performance status (PS) is 0-1 according to the ECOG standard.
3) Participants have given written consent to participate in the research.
Key exclusion criteria
1) Patients with a tendency to bleed.
2) Patients with liver cirrhosis corresponding to Child-Pugh score B-C.
3) Those with chronic renal failure during maintenance dialysis.
4) Those judged to be inappropriate for participation in this study by the attending physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Goto |
Organization
Nippon Medical School
Division name
Department of Gastroenterology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
o-goto@nms.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Goto |
Organization
Nippon Medical School
Division name
Department of Gastroenterology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
o-goto@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
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
Nippon Medical School
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
Tel
03-3822-2131
nms_fuzokurinri@nms.ac.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
| 2021 | Year | 03 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to prospectively investigate whether the circularity of the tumor measured using EUS still images is useful for the differential diagnosis of gastric submucosal tumors.
For pathological diagnosis of tumor, tissue obtained by boring biopsy, EUS-FNA, mucosal incision biopsy, or surgery is used.
Management information
Registered date
| 2021 | Year | 03 | Month | 08 | Day |
Last modified on
| 2021 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049735
