UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052106 |
|---|---|
| Receipt number | R000059452 |
| Scientific Title | Investigation of clinical usefulness of ultrasound endoscopy-guided biopsy in the field of digestive diseases |
| Date of disclosure of the study information | 2023/09/04 |
| Last modified on | 2023/09/04 20:13:36 |
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Basic information
Public title
Clinicopathological investigation of synchronous malignancies in patients with preoperatively diagnosed gastric GIST by endoscopic ultrasonography-guided fine-needle aspiration (A retrospective study)
Acronym
Investigation of synchronous malignancy of gastric GIST
Scientific Title
Investigation of clinical usefulness of ultrasound endoscopy-guided biopsy in the field of digestive diseases
Scientific Title:Acronym
EUS-FNA for Digestive disease
Region
| Japan |
Condition
Condition
Gastric GIST
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clinicopathologic characterization of synchronous malignancies in patients with preoperatively diagnosed gastric GIST by EUS-FNA
Basic objectives2
Others
Basic objectives -Others
Investigation of clinicopathological feature
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of synchronous malignancies
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Preoperative EUS-FNA diagnosis was GIST
Key exclusion criteria
Preoperative EUS-FNA diagnosis was other than GIST
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Akahoshi |
Organization
Iizuka Hospital
Division name
Endoscopy Center
Zip code
820-8505
Address
Yoshio 3-83 Iizuka, Japan
TEL
0948-22-3800
kakahoshi2@aol.com
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Akahoshi |
Organization
Iizuka Hospital
Division name
Endoscopy Center
Zip code
820-8505
Address
Yoshio3-83, Iizuka, Japan
TEL
0948-22-3800
Homepage URL
kakahoshi2@aol.com
Sponsor or person
Institute
Iizuka Hospital
Institute
Department
Personal name
Kazuya Akahoshi
Funding Source
Organization
Iizuka Hospital
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
Ethical board of Iizuka Hospital
Address
Yoshio3-83, Iizuka, Japan
Tel
0948 22 3800
rinri@aih-net.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
| 2023 | Year | 09 | Month | 04 | 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
184
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2006 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2023 | Year | 09 | Month | 04 | Day |
Last modified on
| 2023 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059452
