UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026267 |
|---|---|
| Receipt number | R000028973 |
| Scientific Title | Associations of the velocity of superior thyroid artery with thyroid diseases and psychiatric disorders |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2018/09/15 08:40:24 |
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Basic information
Public title
Associations of the velocity of superior thyroid artery with thyroid diseases and psychiatric disorders
Acronym
Associations of the velocity of superior thyroid artery with thyroid diseases and psychiatric disorders
Scientific Title
Associations of the velocity of superior thyroid artery with thyroid diseases and psychiatric disorders
Scientific Title:Acronym
Associations of the velocity of superior thyroid artery with thyroid diseases and psychiatric disorders
Region
| Japan |
Condition
Condition
hyperthyroidism/thyrotoxicosis and mental disorders
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Psychosomatic Internal Medicine |
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical feasibility of measuring peak systolic velocity of superior thyroid artery (STA-PSV) for differential diagnosis of hyperthyroidism/thyrotoxicosis, and the differences in STA-PSV between patients with and without mental disorders (MD).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thyroid volume(length,width,depth),STA-PSV,clinical diagnosis of thyroid diseases
Key secondary outcomes
Age,sex,height,weight,BMI,blood pressure,TSH,FT3,FT4,autoantibodies(TRAb,TSAb,TgAb,TPOAb),thyroglobulin,with and without MD,clinical diagnosis of MD
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among subjects who had undergone a thyroid ultrasonography between April 2013 and November 2016 at National Center for Global Health and Medicine Kohnodai Hospital, Chiba, Japan.
Key exclusion criteria
Subjects who were younger than 20 years, had a thyroid cancer, and received a radioiodine therapy or surgical therapy.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Marino Morikawa, Yanai Hidekatsu |
Organization
National Center for Global Health and Medicine Kohnodai Hospital
Division name
Department of Internal Medicine.
Zip code
Address
kohnodai1-7-1,Itikawa-City,Chiba,Japan
TEL
047-372-3501
dyanai@hospk.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Marino Morikawa |
Organization
National Center for Global Health and Medicine Kohnodai Hospital
Division name
Department of Internal Medicine
Zip code
Address
kohnodai1-7-1,Itikawa-City,Chiba,Japan
TEL
047-372-3501
Homepage URL
mmorikawa-kgw@umin.ac.jp
Sponsor or person
Institute
National Center for Global Health and Medicine Kohnodai Hospital
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
国立国際医療研究センター国府台病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | 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 | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Cross-sectional study. Setting & Participants: Among subjects who had undergone a thyroid ultrasonography between April 2013 and November 2016.
Management information
Registered date
| 2017 | Year | 02 | Month | 22 | Day |
Last modified on
| 2018 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028973
