UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013970 |
|---|---|
| Receipt number | R000016275 |
| Scientific Title | I-131 therapy for metastatic thyroid cancer with recombinant human thyroid-stimulating hormone (Thyrogen) |
| Date of disclosure of the study information | 2014/05/16 |
| Last modified on | 2018/05/20 07:56:32 |
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Basic information
Public title
I-131 therapy for metastatic thyroid cancer with recombinant human thyroid-stimulating hormone (Thyrogen)
Acronym
I-131 therapy for metastatic thyroid cancer with recombinant human thyroid-stimulating hormone
Scientific Title
I-131 therapy for metastatic thyroid cancer with recombinant human thyroid-stimulating hormone (Thyrogen)
Scientific Title:Acronym
I-131 therapy for metastatic thyroid cancer with recombinant human thyroid-stimulating hormone
Region
| Japan |
Condition
Condition
Thyroid cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy of I-131 therapy with recombinant human thyroid-stimulating hormone in metastatic thyroid cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of anti-tumor effects with tumor uptake and tumor markers
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
recombinant human thyroid-stimulating hormone
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) a patient with distant metastases of thyroid cancer, who underwent total thyroidectomy or almost total thyroidectomy for differenciated thyroid cancer
2) a patient who underwent thyroidectomy before 6 weeks or more
Key exclusion criteria
1) a patient whose thyroid Ca has not able to uptake I-131
2) a patient with clitical disease
3) a patient who was administered an iodinated contrast agent
4) pregnant female and feeding female
5) when medical staff determine that treatment can not be properly carried out
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsutaka Okizaki |
Organization
Asahikawa Medical University
Division name
Department of Radiology
Zip code
Address
2-1-1-1, Midorigaokahigashi, Asahikawa, Hokkaido, Japan
TEL
+166-68-2572
okizaki@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsutaka Okizaki |
Organization
Asahikawa Medical University
Division name
Department of Radiology
Zip code
Address
2-1-1-1, Midorigaokahigashi, Asahikawa, Hokkaido, Japan
TEL
+166-68-2572
Homepage URL
okizaki@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
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
Address
Tel
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
| 2014 | Year | 05 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 16 | Day |
Last modified on
| 2018 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016275
| 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 |
