UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024244 |
|---|---|
| Receipt number | R000027880 |
| Scientific Title | Ultrasonography based diagnosis of Thyroid Nodules |
| Date of disclosure of the study information | 2016/10/03 |
| Last modified on | 2016/09/30 20:30:51 |
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Basic information
Public title
Ultrasonography based diagnosis of Thyroid Nodules
Acronym
Ultrasonography based diagnosis of Thyroid Nodules
Scientific Title
Ultrasonography based diagnosis of Thyroid Nodules
Scientific Title:Acronym
Ultrasonography based diagnosis of Thyroid Nodules
Region
| Japan |
Condition
Condition
Thyroid nodules
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish a diagnostic tool for thyroid noduleson the basis of ultrasonography.
Basic objectives2
Others
Basic objectives -Others
Retrospective examination on the diagnostic accuracy for thyroid nodules of both our original flowchart and TIRADS classification.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The diagnostic accuracy of our original flowchart and TIRADS
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
| 15 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent US-guided fine-needle aspiration cytology (FNAC) in our institution between 2007 and 2015
Key exclusion criteria
Informed consent was obtained in the form of opt-out on the web-site. Those who rejected were excluded.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takamura Toshinari |
Organization
Kanazawa University Hospital
Division name
Endocrinology and Metabolism 1
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2233
ttakamura@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamura Toshinari |
Organization
Kanazawa University Hospital
Division name
Endocrinology and Metabolism 1
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2233
Homepage URL
ttakamura@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University Hospital
Endocrinology and Metabolism 1
Institute
Department
Personal name
Funding Source
Organization
Self funding
Kanazawa University Hospital
Endocrinology and Metabolism 1
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
金沢大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 03 | 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
| 2007 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 02 | Month | 01 | Day |
Other
Other related information
A total of 1237 thyroid nodules which underwent US-guided fine-needle aspiration cytology (FNAC) from 2007 to 2015 were retrospectively evaluated on their US features and cytological diagnosis.
Management information
Registered date
| 2016 | Year | 09 | Month | 30 | Day |
Last modified on
| 2016 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027880
| 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 |
