UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030981 |
|---|---|
| Receipt number | R000035349 |
| Scientific Title | Inter-rater agreement on the Endoscopic ultrasound feature of lymphadenopathy |
| Date of disclosure of the study information | 2018/01/24 |
| Last modified on | 2019/03/04 18:42:15 |
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Basic information
Public title
Inter-rater agreement on the Endoscopic ultrasound feature of lymphadenopathy
Acronym
Inter-rater agreement on the Endoscopic ultrasound feature of lymphadenopathy
Scientific Title
Inter-rater agreement on the Endoscopic ultrasound feature of lymphadenopathy
Scientific Title:Acronym
Inter-rater agreement on the Endoscopic ultrasound feature of lymphadenopathy
Region
| Japan |
Condition
Condition
lymphadenopathy
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Findings with a high degree of interrater agreement from the ultrasonographic findings adopted in the EUS diagnostic criteria for lymphadenopathy with the objective of proposing new diagnostic criteria for lymphadenopathy using EUS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
interrater agreement from the ultrasonographic findings for lymphadenopathy
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
| 22 | years-old | <= |
Age-upper limit
| 91 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
EUS-FNA for lymphadenopathy of unknown origin observed in the mediastinal and abdominal cavities at Aizu Medical Center of Fukushima Medical University between June 2013 and August 2017.
Key exclusion criteria
biopsy and cytology were insufficient case
Target sample size
71
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Irisawa |
Organization
Aizu Medical center, Fukushima Medical University
Division name
Department of Gastroenterology
Zip code
Address
21-2 Maeda yazawa kawahigashicho aizuwakamatsu-si Fukushima, Japan
TEL
0242-75-2100
irisawa@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Takasaki |
Organization
Aizu Medical center, Fukushima Medical University
Division name
Department of Gastroenterology
Zip code
Address
21-2 Maeda yazawa kawahigashicho aizuwakamatsu-si Fukushima, Japan
TEL
0242-75-2100
Homepage URL
magidora9@gmail.com
Sponsor or person
Institute
Aizu Medical center, Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Aizu Medical center, Fukushima Medical University
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
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
| 2018 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2017 | Year | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 01 | Day |
Other
Other related information
Our subjects were 60 patients (with 68 lesions) who were subjected to detailed EUS observation and EUS-FNA for lymphadenopathy of unknown origin observed in the mediastinal and abdominal cavities at Aizu Medical Center of Fukushima Medical University between June 2013 and August 2017.
Management information
Registered date
| 2018 | Year | 01 | Month | 24 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035349
| 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 |
