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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Thyroid nodules | ||
Classification by specialty |
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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 | |
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Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Type of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Organization | Kanazawa University Hospital | ||||||
Division name | Endocrinology and Metabolism 1 | ||||||
Zip code | |||||||
Address | 13-1 Takara-machi, Kanazawa, Ishikawa | ||||||
TEL | 076-265-2233 | ||||||
ttakamura@m-kanazawa.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
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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 |
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Last modified on |
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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 |