UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047660 |
|---|---|
| Receipt number | R000054301 |
| Scientific Title | The influence of therapeutic inorganic iodine for Graves' disease on long-term prognosis. |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2022/05/06 12:06:39 |
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Basic information
Public title
The influence of therapeutic inorganic iodine for Graves' disease on long-term prognosis.
Acronym
The influence of therapeutic inorganic iodine for Graves' disease on long-term prognosis.
Scientific Title
The influence of therapeutic inorganic iodine for Graves' disease on long-term prognosis.
Scientific Title:Acronym
The influence of therapeutic inorganic iodine for Graves' disease on long-term prognosis.
Region
| Japan |
Condition
Condition
Graves' disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Research for recurrence rate of Graves' hyperthyroidism during and after discontinuation of inorganic iodine treatment
Basic objectives2
Others
Basic objectives -Others
Analysis of factors related to the recurrence of Graves' hyperthyroidism
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence rate of Graves' hyperthyroidism during and after discontinuation of inorganic iodine treatment
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) A patient's age at the registration of present study is 20< and <85 years old.
(2) A patient with Graves' disease treated only with inorganic iodine
(3) Therapeutic dose is less than 25 mg/day as potassium iodine.
(4) Thyroid function maintain normal range (>1.0 microIU/mL) at recently more than 2 times.
(5) Serum TSH receptor antibody measured by M22 antibody based assay is <10 IU/L.
Fulfill the criteria (2)-(5) for more than 6 months before registration.
(6) A patient who agrees with the informed consent of present study.
Key exclusion criteria
(1) A patient is treated with anti-thyroid drugs except inorganic iodine.
(2) A patient is not pregnant woman or lactating woman or expected pregnancy within recent 2 years.
(3) A patient has uncontrolled Graves' disease or untreated heart disease.
(4) A patient has already treated with radioiodine or surgery.
(5) A patient is inappropriate for present study by judging from the manager of the study.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Uchida |
| Middle name | |
| Last name | Toyoyoshi |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism & Endocrinology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo, Tokyo, Japan
TEL
03-5802-1579
uchitoyo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Uchida |
| Middle name | |
| Last name | Toyoyoshi |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism & Endocrinology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo, Tokyo, Japan
TEL
03-5802-1579
Homepage URL
uchitoyo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
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
ethics committee of Juntendo University Hospital
Address
2-1-1 Hongo, Bunkyo, Tokyo, Japan
Tel
03-3813-3111
uchitoyo@juntendo.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
| 2022 | Year | 06 | Month | 01 | 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
56
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
| 2018 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After making decision of treatment for patients with Graves' disease treated with inorganic iodine, the patients is observed at the out-patient clinic for two years.
Management information
Registered date
| 2022 | Year | 05 | Month | 06 | Day |
Last modified on
| 2022 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054301
