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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039003
Receipt No. 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

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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
Email 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
Email mkawaguchi@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044447

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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