UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027236 |
|---|---|
| Receipt number | 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 | 2023/03/21 14:47:32 |
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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
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
s-izawa@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Faculty of Medicine
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
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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 12 | 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
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 05 | Month | 03 | Day |
Last modified on
| 2023 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029528
