UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021900 |
|---|---|
| Receipt number | R000025247 |
| Scientific Title | The study on the safety of perchlorate discharge test for Pendred syndrome patients |
| Date of disclosure of the study information | 2016/04/19 |
| Last modified on | 2019/03/29 05:09:25 |
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Basic information
Public title
The study on the safety of perchlorate discharge test for Pendred syndrome patients
Acronym
The study on the safety of perchlorate test
Scientific Title
The study on the safety of perchlorate discharge test for Pendred syndrome patients
Scientific Title:Acronym
The study on the safety of perchlorate test
Region
| Japan |
Condition
Condition
Pendred syndrome
Classification by specialty
| Endocrinology and Metabolism | Endocrine surgery | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the safety of perchrolate discharge test for Pendred syndrome patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the safety. Intake rate test by scintigraphy is performed 3 hrs after 123I intake.
Key secondary outcomes
To assess the efficacy. Intake rate and thyroid function tests are performed after perchlorate administration.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Intake rate test by schincigraphy is performed 3 hrs after induction of 123I intake. Perchlorate (20 mg/kg for over 3 years old (e.g.0.6 g for 6 years old) and 1.0 g for over 50 kg body weight or adults)is administerred when intake rate is above the set point.
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
All patients who are eligible to the follosing criteria.
1) Pendred syndrome suspected patients with sensorineural hearing loss and thyroid goiter.
2) Patients or their guardians if the patients are children who understand our explanation completely with written informed consent signed and dated.
Key exclusion criteria
1) Patients who do not consent to our study.
2) Patients judged by investigators ineligible due to seriousness of patients condition.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Tanaka |
Organization
Chiba University Graduate School of Medicine
Division name
Clinical Cell Biology and Medicine
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL
043-222-7171
tomoaki@restaff.chiba-u.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Koide |
Organization
Chiba University Graduate School of Medicine
Division name
Clinical Cell Biology and Medicine
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL
043-222-7171
Homepage URL
koideh@chiba-u.jp
Sponsor or person
Institute
Chiba university hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Chiba university hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Japan
Tel
0432227171
tomoaki@restaff.chiba-u.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 | 04 | Month | 19 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 02 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 13 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025247
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
