UMIN-CTR Clinical Trial

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
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Institution consideration
Blocking
Concealment

Intervention
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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
Email	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
Email	ttakamura@m-kanazawa.jp

Sponsor
Institute	Kanazawa University Hospital Endocrinology and Metabolism 1
Institute
Department

Funding Source
Organization	Self funding Kanazawa University Hospital Endocrinology and Metabolism 1
Organization
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Category of Funding Organization	Self funding
Nationality of Funding Organization

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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
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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
URL(English)	https://upload.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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Research case data
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