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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027236
Receipt No. R000029528
Scientific Title Clinical Significance of Thyroid Incidentaloma detected by Computed Tomography (Tottori, Japan)
Date of disclosure of the study information 2017/05/08
Last modified on 2018/10/30

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Basic information
Public title Clinical Significance of Thyroid Incidentaloma detected by Computed Tomography (Tottori, Japan)
Acronym TI-CT (Tottori)
Scientific Title Clinical Significance of Thyroid Incidentaloma detected by Computed Tomography (Tottori, Japan)
Scientific Title:Acronym TI-CT (Tottori)
Region
Japan

Condition
Condition Thyroid Incidentaloma
Classification by specialty
Medicine in general Endocrinology and Metabolism Endocrine surgery
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to explore the useful manifestations for evaluating thyroid incidentaloma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes Explore CT manifestations associated with thyroid carcinoma and thyroid dysfunction
Key secondary outcomes Explore CT manifestatins associated with:
1) serum thyroid autoantibodies and thyroglobulin.
2) typical ultrasound manifestations, fine-needle aspiration cytology, and histological diagnosis.

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
90 years-old >
Gender Male and Female
Key inclusion criteria Patients, who visited Endocrinology and Metabolism, Tottori University Hospital from October, 2011 to September, 2016, to consult thyroid incidentaloma detected by Computed Tomography evaluating diseases other than thyroid gland
Key exclusion criteria Patients with past history of thyroid disease and those who are not suitable for the research are excluded.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoichiro Izawa
Organization Tottori University Hospital
Division name Endocrinology and Metabolism
Zip code
Address 36-1, Nishi-cho, Yonago, JAPAN
TEL 0859-38-6517
Email s-izawa@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoichiro Izawa
Organization Tottori University Hospital
Division name Endocrinology and Metabolism
Zip code
Address 36-1, Nishi-cho, Yonago, JAPAN
TEL 0859-38-6517
Homepage URL
Email s-izawa@med.tottori-u.ac.jp

Sponsor
Institute Tottori University Faculty of Medicine
Institute
Department

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
Email

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
2017 Year 05 Month 08 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 No longer recruiting
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
2018 Year 09 Month 30 Day
Date trial data considered complete
2018 Year 09 Month 30 Day
Date analysis concluded
2019 Year 09 Month 30 Day

Other
Other related information None

Management information
Registered date
2017 Year 05 Month 03 Day
Last modified on
2018 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029528

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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