UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059253 |
|---|---|
| Receipt number | R000067773 |
| Scientific Title | Optimising radioiodine therapy strategies for thyroid cancer in Japan |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/10/01 01:18:44 |
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Basic information
Public title
Optimising radioiodine therapy strategies for thyroid cancer in Japan
Acronym
Optimising radioiodine therapy strategies for thyroid cancer in Japan
Scientific Title
Optimising radioiodine therapy strategies for thyroid cancer in Japan
Scientific Title:Acronym
Optimising radioiodine therapy strategies for thyroid cancer in Japan
Region
| Japan |
Condition
Condition
Thyroid cancer
Classification by specialty
| Endocrinology and Metabolism | Endocrine surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Establishment of treatment dose and interval aimed at safety and long-term improvement of prognosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression free survival
Preservation of good health and quality of life
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 with thyroid cancer who underwent total thyroidectomy and required radioiodine therapy
Key exclusion criteria
Patients with unknown medical history
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Atsunori |
| Middle name | |
| Last name | Fukuhara |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Metabolic Medicine
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
+81-6-6879-3732
fukuhara@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Rieko |
| Middle name | |
| Last name | Nakatani |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Endocrinology and Metabolism
Zip code
6028566
Address
465 Kajii-cho, Kawaramachi-Hirokoji Kamigyo-ku, Kyoto
TEL
+81-75-251-5505
Homepage URL
rieko425@koto.kpu-m.ac.jp
Sponsor or person
Institute
Osaka University 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
Ethical Review Board of Osaka University Hospital
Address
Yamadaoka 2-2, Suita, Osaka, Japan
Tel
+81-6-6210-8296
rinri@hp-crc.med.osaka-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
| 2025 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
301
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
Main results already published
Date of protocol fixation
| 2019 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study was to evaluate the prognosis and disease characteristics based on initial RAI therapy using image findings.
Specifically,we focused on the initial RAI therapy and investigated its impact on patient prognosis, with particular emphasis on the 131I-avidity of metastatic lesions. Guided by our semi-quantitative 131I imaging analysis,we identified risk factors associated with disease progression, including latent risks, in order to gain further insight into the best treatment strategy.
Management information
Registered date
| 2025 | Year | 10 | Month | 01 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067773
