UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038739 |
|---|---|
| Receipt number | R000044082 |
| Scientific Title | Utility of detective flow imaging endoscopic ultrasonography for submucosal lesions |
| Date of disclosure of the study information | 2020/06/19 |
| Last modified on | 2023/12/01 09:24:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Utility of detective flow imaging endoscopic ultrasonography for submucosal lesions
Acronym
DFI-EUS for SMT
Scientific Title
Utility of detective flow imaging endoscopic ultrasonography for submucosal lesions
Scientific Title:Acronym
DFI-EUS for SMT
Region
| Japan |
Condition
Condition
Submucosal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of DFI-EUS for differential diagnosis in submucosal tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the utility of DFI-EUS for differential diagnosis of SMTs
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
DFI-EUS and EUS were performed on the same day. Pathological diagnosis was obtained by EUS fine-needle aspiration biopsy and/or surgical specimen.
Key exclusion criteria
age < 20years
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kitano |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-0012
Address
811-1, Kimiidera, Wakayama City, Wakayama, Japan
TEL
073-447-2300
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasunobu |
| Middle name | |
| Last name | yamashita |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-0012
Address
811-1, Kimiidera, Wakayama City, Wakayama, Japan
TEL
073-447-2300
Homepage URL
yasunobu@wakayama-med.ac.jp
Sponsor or person
Institute
Second Department of Internal Medicine, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Second Department of Internal Medicine, Wakayama Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University
Address
811-1, Kimiidera, Wakayama City, Wakayama, Japan
Tel
073-447-2300/(+81)-73-4472300
yasunobu@wakayama-med.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
| 2020 | Year | 06 | Month | 19 | 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
| 2018 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the utility of DFI-EUS for the differential diagnosis between GIST and other SMTs.
Management information
Registered date
| 2019 | Year | 11 | Month | 29 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044082
