UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019584 |
|---|---|
| Receipt number | R000022622 |
| Scientific Title | Measurement of urinary iodine for the post-operative patients of differentiated thyroid carcinoma |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2022/11/08 14:16:27 |
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Basic information
Public title
Measurement of urinary iodine for the post-operative patients of differentiated thyroid carcinoma
Acronym
Measurement of urinary iodine for the patients of thyroid carcinoma
Scientific Title
Measurement of urinary iodine for the post-operative patients of differentiated thyroid carcinoma
Scientific Title:Acronym
Measurement of urinary iodine for the patients of thyroid carcinoma
Region
| Japan |
Condition
Condition
thyroid carcinoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the influence of urinary iodine for the I-131 therapy for the patients of diffentiated thyroid carcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We assess the outcome with the I-131 scintigraphy and serum thyroglobulin level 6 to 8 months after the I-131 therapy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Diagnosis
Type of intervention
| Food | Maneuver |
Interventions/Control_1
method of restriction in iodine-intake: A, method of stimulating TSH: A
(method of restriction in iodine-intake: A:self-control B:use of packed low-iodine diet
method of stimulating TSH: A: withdrawal of tyroid hormone B: administration of recombinant human TSH)
Interventions/Control_2
method of restriction in iodine-intake: B, method of stimulating TSH: A
Interventions/Control_3
method of restriction in iodine-intake: A, method of stimulating TSH: B
Interventions/Control_4
method of restriction in iodine-intake: B, method of stimulating TSH: B
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The post-operative patients with differentiated tyroid carcinoma who consent to this study in writing and undergo I-131 therapy.
Key exclusion criteria
The patients whose urine sample are not able to taken, and the patients who are not able to take meals.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Ito |
Organization
Nagoya University Hospital
Division name
Department of Radiology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2327
itoshj@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Ito |
Organization
Nagoya University Hospital
Division name
Department of Radiology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2327
Homepage URL
itoshj@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics comittee of Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
Tel
052-744-2881
ethics@med.nagoya-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
| 2016 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s12149-018-1261-0
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12149-018-1261-0
Number of participants that the trial has enrolled
45
Results
Post-LID urinary iodine levels of the strict LID group tended to be lower than those of the self-managed LID group. Twenty-five cases (56%) showed absence of uptake, whereas 20 cases (44%) showed residual uptake on the response-evaluation WBS. There were no significant differences between "absence" and "residual" groups in urinary iodine concentrations and Tg levels (p = 0.253 and p = 0.234, respectively). However, significant differences were observed in I-131 uptake by the thyroid bed (p = 0.035).
Results date posted
| 2022 | Year | 11 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Japanese patients with differentiated thyroid cancer who received initial I-131 remnant ablation using a fixed low dose of I-131 (1110 MBq).
Participant flow
Patients were classified into a self-managed LID group and a strict LID group. We measured the urinary iodine concentration on the day of RAI after patients consumed LID for 2 weeks. A response-evaluation whole-body scan (WBS) was performed 6-8 months after RAI to determine the outcome of the therapy.
Adverse events
Nothing was seen.
Outcome measures
To identify prognostic factors associated with a low-iodine diet (LID) and the amount of remnant thyroid tissue in Japanese patients with differentiated thyroid cancer.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 31 | Day |
Last modified on
| 2022 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022622
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