UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039003 |
|---|---|
| Receipt number | R000044447 |
| Scientific Title | The study on lipid components of epidermis in patients with FAHN |
| Date of disclosure of the study information | 2020/01/31 |
| Last modified on | 2020/12/26 11:06:17 |
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Basic information
Public title
The study on lipid components of epidermis in patients with FAHN
Acronym
Lipid components of epidermis in patients with FAHN
Scientific Title
The study on lipid components of epidermis in patients with FAHN
Scientific Title:Acronym
Lipid components of epidermis in patients with FAHN
Region
| Japan |
Condition
Condition
FAHN(fatty acid hydroxylase-associated neurodegeneration)
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate FA2H gene function by analyzing lipid components of FAHN patients
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the lipid components of epidermis, the amount of percutaneous water evaporation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1,persons with FA2H gene mutation.
2,persons who got consent in document
Key exclusion criteria
1,persons who cannot be tested because of their skin condition
2,when consent cannot be obtaind
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kidokoro |
Organization
Nagoya University Hospital
Division name
Department of Pediatrics
Zip code
466-8550
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, JAPAN
TEL
052-744-2295
kidokoro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Kawaguchi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
466-8550
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, JAPAN
TEL
052-744-2295
Homepage URL
mkawaguchi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
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
Nagoya University Ethics Review Committee
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, JAPAN
Tel
052-744-2061
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
| 2020 | Year | 01 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will analyze the lipd components of epidermis and measure the amount of percutaneous water evaporation in patients with FAHN.
Management information
Registered date
| 2019 | Year | 12 | Month | 26 | Day |
Last modified on
| 2020 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044447
