UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016555 |
|---|---|
| Receipt number | R000019212 |
| Scientific Title | A retrospective cohort study to evaluate the accuracy of preoperative risk classification of gastrointestinal stromal tumor by endoscopic ultrasound-guided fine needle aspiration biopsy using a 19 gauge needle |
| Date of disclosure of the study information | 2015/02/20 |
| Last modified on | 2016/05/12 18:52:26 |
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Basic information
Public title
A retrospective cohort study to evaluate the accuracy of preoperative risk classification of gastrointestinal stromal tumor by endoscopic ultrasound-guided fine needle aspiration biopsy using a 19 gauge needle
Acronym
Preoperative risk classification of GIST by EUS-FNA
Scientific Title
A retrospective cohort study to evaluate the accuracy of preoperative risk classification of gastrointestinal stromal tumor by endoscopic ultrasound-guided fine needle aspiration biopsy using a 19 gauge needle
Scientific Title:Acronym
Preoperative risk classification of GIST by EUS-FNA
Region
| Japan |
Condition
Condition
GIST
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the accuracy of preoperative risk classification of gastrointestinal stromal tumor by endoscopic ultrasound-guided fine needle aspiration biopsy using a 19 gauge needle
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Co-efficiency of the recurrence risk classification of GIST between EUS-FNA samples and resected specimens
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
Patients with submucosal lesion of stomach which was judged we can perform EUS-FNA
Key exclusion criteria
1)Age below 20 years
2) Patients with bleeding tendency
3) Patients whose informed consent could not be obtained.
4)In case that doctors judged inappropriate for the entry
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Teikyo University Mizonokuchi Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-8-3 Mizonokuchi, Takatsu-ku, Kawasaki, 213-8507, Japan
TEL
+81-44-844-3333
YASUDAIC@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Teikyo University Mizonokuchi Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-8-3 Mizonokuchi, Takatsu-ku, Kawasaki, 213-8507, Japan
TEL
+81-44-844-3333
Homepage URL
YASUDAIC@aol.com
Sponsor or person
Institute
19 gauge EUS-FNA for GSMT group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 02 | Month | 20 | 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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We can exactly predict the recurrence risk of GISTs before surgical therapy.
Management information
Registered date
| 2015 | Year | 02 | Month | 16 | Day |
Last modified on
| 2016 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019212
