UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010417 |
|---|---|
| Receipt number | R000012183 |
| Scientific Title | Estimation for adequacy of histopathologic specimen based on macroscopic findings of specimen obtained by EUS-FNA using 19-gauge needle |
| Date of disclosure of the study information | 2013/04/04 |
| Last modified on | 2015/01/17 00:55:20 |
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Basic information
Public title
Estimation for adequacy of histopathologic specimen based on macroscopic findings of specimen obtained by EUS-FNA using 19-gauge needle
Acronym
Estimation Study
Scientific Title
Estimation for adequacy of histopathologic specimen based on macroscopic findings of specimen obtained by EUS-FNA using 19-gauge needle
Scientific Title:Acronym
Estimation Study
Region
| Japan |
Condition
Condition
Solid tumor around the upper intestine
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate correlation between macroscopic findings of EUS-FNA specimen obtained a 19-gauge needle and adequacy of specimen for histopathological analysis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate correlation between macroscopic findings of EUS-FNA specimen obtained a 19-gauge needle and adequacy of specimen for histopathological analysis
Key secondary outcomes
Disagnostic power of EUS-FNA using 19-gauge needle
Safety
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
1)patients with solid tumor around the upper intestine
2)performance status of 0-3
3)life expectancy more than 4 weeks
4)written informed consent obtained from the patient
Key exclusion criteria
1)severe bleeding tendency
2)severe cardiac disease, severe pulmonary disease, severe renal disease
4)pregnancy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Gifu University Hospital
Division name
First Dept. of Internal Medicine
Zip code
Address
1-1 Yanagido, Gifu, Gifu, Japan
TEL
058-230-6308
takuji@w7.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuji Iwashita |
Organization
Gifu University Hospital
Division name
First Dept. of Internal Medicine
Zip code
Address
1-1 Yanagito, Gifu
TEL
058-230-6308
Homepage URL
takuji-guh@umin.ac.jp
Sponsor or person
Institute
Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
岐阜大学医学部附属病院（岐阜県）Gifu University Hospital(Gifu)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | 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
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
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study.
Management information
Registered date
| 2013 | Year | 04 | Month | 04 | Day |
Last modified on
| 2015 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012183
