UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045414 |
|---|---|
| Receipt number | R000051853 |
| Scientific Title | A phase II trial of the efficacy and safety of boring biopsy with rapid on-site evaluation for histological diagnosis of gastric mesenchymal tumor |
| Date of disclosure of the study information | 2021/09/08 |
| Last modified on | 2022/07/20 21:29:42 |
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Basic information
Public title
A phase II trial of the efficacy and safety of boring biopsy with rapid on-site evaluation for histological diagnosis of gastric mesenchymal tumor
Acronym
A phase II trial of the efficacy and safety of boring biopsy with rapid on-site evaluation for histological diagnosis of gastric mesenchymal tumor
Scientific Title
A phase II trial of the efficacy and safety of boring biopsy with rapid on-site evaluation for histological diagnosis of gastric mesenchymal tumor
Scientific Title:Acronym
A phase II trial of the efficacy and safety of boring biopsy with rapid on-site evaluation for histological diagnosis of gastric mesenchymal tumor
Region
| Japan |
Condition
Condition
Gastric mesenchymal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic ability and safety of boring biopsy with rapid on-site evaluation for histological diagnosis of gastric mesenchymal tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of cases diagnosed with GIST
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
Primary registration eligibility criteria:
-Patients who will undergo endoscopic ultrasonography for gastric submucosal tumors.
-The age at the time of registration is 20 years or older.
-Performance status is ECOG 0-2.
-Written consent has been obtained from the patient for participation in the study.
Secondary registration eligibility criteria:
-Endoscopic ultrasonography shows that the lesion is a hypoechoic mass with a diameter of 20 mm or more that is continuous with the 4th layer.
Key exclusion criteria
-The lesion is difficult to recognize by white light endoscopy.
-The Lesion is present in the cardia.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kanesaka |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka
TEL
+81-6-6945-1181
takashikanesaka@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kanesaka |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka
TEL
+81-6-6945-1181
Homepage URL
takashikanesaka@gmail.com
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Osaka International Cancer Institute
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
Institutional Review Board of Osaka International Cancer Institute
Address
3-1-69 Otemae, Chuo-ku, Osaka
Tel
+81-6-6945-1181
rinri01@opho.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 | 09 | 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
| 2021 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 09 | Month | 07 | Day |
Last modified on
| 2022 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051853
| 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 |
