UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055604 |
|---|---|
| Receipt number | R000063509 |
| Scientific Title | Investigation of Endoscopic Thyroidectomy for Thyroid Carcinoma In Tokyo |
| Date of disclosure of the study information | 2024/09/25 |
| Last modified on | 2025/09/29 09:13:50 |
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Basic information
Public title
Investigation of Endoscopic Thyroidectomy for Thyroid Carcinoma In Tokyo
Acronym
Tokyo Endoscopic Thyroidectomy Study (TETS)
Scientific Title
Investigation of Endoscopic Thyroidectomy for Thyroid Carcinoma In Tokyo
Scientific Title:Acronym
Tokyo Endoscopic Thyroidectomy Study (TETS)
Region
| Japan |
Condition
Condition
Thyroid carcinoma
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the trends and outcomes of endoscopic thyroidectomy for thyroid carcinoma, targeting cases registered in the Tokyo Cancer Registry, including those before and after the procedure became covered by insurance in 2018. A comparison with open surgery will also be conducted.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival (OS)
Key secondary outcomes
Disease-specific survival, 90-day and 180-day mortalities from diagnosis, transition in endoscopic eligibility rates, and evaluation of factors influencing the choice of endoscopic surgery.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients registered in the Tokyo Cancer Registry between 2012 and 2020, with ICD-O3 code C739 and excluding ICD-10 code C73.
Key exclusion criteria
Histopathological diagnosis other than papillary or follicular thyroid carcinoma, and cases where the type of surgery (endoscopic or open) is unclear.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Saito |
Organization
Ito hospital
Division name
Department of Surgery
Zip code
160-8582
Address
4-3-6 Jinguumae, Shibuya-ku, Tokyo, Japan
TEL
+81-3-3402-7411
y-saito@ito-hospital.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Saito |
Organization
Ito hospital
Division name
Department of Surgery
Zip code
160-8582
Address
4-3-6 Jinguumae, Shibuya-ku, Tokyo, Japan
TEL
+81-3-3402-7411
Homepage URL
y-saito@ito-hospital.jp
Sponsor or person
Institute
Ito hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ito Hospital Institutional Review Board
Address
4-3-6 Jinguumae, Shibuya-ku, Tokyo, Japan
Tel
+81-3-3402-7411
k-sugino@ito-hospital.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 | 09 | Month | 25 | 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
11989
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 14 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 14 | Day |
Date analysis concluded
Other
Other related information
Objective:
To investigate the trends and outcomes of endoscopic surgery for thyroid carcinoma using data from the Tokyo Cancer Registry.
Design:
Retrospective observational study using data from the Tokyo Cancer Registry.
Setting:
This study utilizes the Tokyo Cancer Registry data. Data extraction and analysis will be conducted ensuring confidentiality and compliance with all applicable regulations.
Participants:
Patients registered in the Tokyo Cancer Registry between 2012 and 2020 who underwent either endoscopic or open thyroid surgery.
Main Outcome and Measure:
The primary outcome is overall survival (OS). Secondary outcomes include disease-specific survival, 90-day and 180-day mortalities from diagnosis, the transition of endoscopic eligibility rates, and an evaluation of factors influencing the choice of endoscopic surgery.
Management information
Registered date
| 2024 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063509
