UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024244
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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 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
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
Registered date File name

Research case data
Registered date File name


Contact us.