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

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 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

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

Value
https://center6.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