UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022565
Receipt number R000026005
Scientific Title The analysis for melanogenesis in the pathogenesis of Mowat-Wilson syndrome
Date of disclosure of the study information 2016/08/01
Last modified on 2016/08/12 13:19:17

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Basic information

Public title

The analysis for melanogenesis in the pathogenesis of Mowat-Wilson syndrome

Acronym

The analysis for melanogenesis in the pathogenesis of Mowat-Wilson syndrome

Scientific Title

The analysis for melanogenesis in the pathogenesis of Mowat-Wilson syndrome

Scientific Title:Acronym

The analysis for melanogenesis in the pathogenesis of Mowat-Wilson syndrome

Region

Japan


Condition

Condition

hair

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the melanogenesis in the pathogenesis of
Mowat-Wilson syndrome

Basic objectives2

Others

Basic objectives -Others

To clarify the new aspect of the pathogenesis of
Mowat-Wilson syndrome

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To measure the quantity of melanin in hair of patients with Mowat-Wilson syndrome and healthy volunteers.

Key secondary outcomes

To observe the color of hair of patients with Mowat-Wilson syndrome and healthy volunteers.


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

Patients with Mowat-Wilson syndrome

Key exclusion criteria

Patients with no Mowat-Wilson syndrome

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kimiko Nakajima

Organization

Kochi Medical School, Kochi University

Division name

Department of Dermatology

Zip code


Address

Kohasu, Okohcho, Nanakoku, Kochi

TEL

088-880-2363

Email

nakajimk@kochi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kimiko Nakajima

Organization

Kochi Medical School, Kochi University

Division name

Department of Dermatology

Zip code


Address

Kohasu, Okohcho, Nanakoku, Kochi

TEL

088-880-2363

Homepage URL


Email

nakajimk@kochi-u.ac.jp


Sponsor or person

Institute

Department of Dermatology
Kochi Medical School, Kochi University

Institute

Department

Personal name



Funding Source

Organization

Department of Dermatology
Kochi Medical School, Kochi 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


Address


Tel


Email



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

高知大学附属病院皮膚科


Other administrative information

Date of disclosure of the study information

2016 Year 08 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


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

Preinitiation

Date of protocol fixation

2016 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 03 Month 31 Day

Date trial data considered complete

2021 Year 03 Month 31 Day

Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information

To measure quantity of melanin in hair of patients with
Mowat-Wilson syndrome


Management information

Registered date

2016 Year 06 Month 01 Day

Last modified on

2016 Year 08 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026005


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name