UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053547 |
|---|---|
| Receipt number | R000061094 |
| Scientific Title | Data analysis to improve thyroid ultrasound diagnostic performance using ACR-TIRADS, a standard established by the American College of Radiology |
| Date of disclosure of the study information | 2024/02/06 |
| Last modified on | 2024/02/05 18:36:11 |
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Basic information
Public title
Data Analysis to Improve Thyroid Ultrasound Diagnostic Performance Using ACR-TIRADS
Acronym
Analysis of Thyroid Ultrasonography Using ACR-TIRADS
Scientific Title
Data analysis to improve thyroid ultrasound diagnostic performance using ACR-TIRADS, a standard established by the American College of Radiology
Scientific Title:Acronym
Analysis of Thyroid Ultrasonography Using ACR-TIRADS
Region
| Japan |
Condition
Condition
thyroid nodules (nodular goiter, adenomatous goiter), papillary thyroid carcinoma
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will confirm the validity of ACR-TIRADS, which has been reported to have high diagnostic performance, by retrospectively evaluating the results of thyroid ultrasonography in Japan. We will also examine factors that contribute to improved diagnostic performance, with the aim of establishing a more useful ultrasonographic method in actual clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sensitivity, specificity, and negative/positive predictive value of ACR-TIRADS for the diagnosis of malignancy in thyroid nodules. In addition, the cut-off value and hazard ratio of ACR-TIRADS for the diagnosis of malignant tumors will be examined.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with thyroid nodules who underwent thyroid ultrasound examination at Hirosaki University Hospital or Hachinohe City Hospital after October 2017 and were confirmed by cytological or histological diagnosis, or both.
Key exclusion criteria
Cases with unverifiable cytology and histology results, insufficiently described ultrasound results, follicular or medullary thyroid cancer, poorly differentiated carcinoma, malignant lymphoma or undifferentiated carcinoma.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Watanuki |
Organization
Hirosaki University Hospital
Division name
Endocrinology and metabolism
Zip code
036-8562
Address
5 Zaihu-cho, Hirosaki-shi, Aomori
TEL
0172-39-5062
waji0927@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Watanuki |
Organization
Hirosaki University hospital
Division name
Depatment of Endocrinology and Metabolism
Zip code
036-8562
Address
5, Zaihu-cho, Hirosaki-shi, Aomori
TEL
0172-39-5062
Homepage URL
waji0927@yahoo.co.jp
Sponsor or person
Institute
Yutaka Watanuki, Department of Endocrinology and Metabolism, Hirosaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yutaka Watanuki, Department of Endocrinology and Metabolism, Hirosaki University Hospital
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
Clinical Trial Management Center, Hirosaki university Hospital
Address
53, Hon-cho, Hirosaki-shi, Aomori
Tel
0172-39-5295
rinri@hirosaki-u.ac.jp
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
| 2024 | Year | 02 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study design is a retrospective design that refers to historical data. Personal information will be anonymized by registry number, and information ascertained by clinical examination will be used only for statistical studies.
Management information
Registered date
| 2024 | Year | 02 | Month | 05 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061094
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
