UMIN-CTR Clinical Trial

Public title

Database-construction to study the etiology of skin diseases

Acronym

Database-construction to study the etiology of skin diseases

Scientific Title

Database-construction to study the etiology of skin diseases

Scientific Title:Acronym

Database-construction to study the etiology of skin diseases

Region

Japan

Condition

Skin-related diseases

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this project is to accumulate clinical, biochemical and pathological data for later use in elucidating the pathogenesis of skin diseases using residual and surplus specimens of blood, tissue, skin secretions and desquamation used for testing in normal medical practice.

Basic objectives2

Others

Basic objectives -Others

Database-construction

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Establishing new treatment by elucidating the pathogenesis of skin diseases

Key secondary outcomes

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who visited the Department of Dermatology and Allergy, Nagasaki University Hospital with a chief complaint of skin disease during the period from the date of approval by the head of the research institute to February 28, 2025

Key exclusion criteria

none

Target sample size

Name of lead principal investigator

1st name	Hiroyuki
Middle name
Last name	Murota

Organization

Nagasaki university

Division name

Dermatology

Zip code

8528501

Address

1-7-1, Sakamoto, Nagasaki city

TEL

0958197331

Email

h-murota@nagasaki-u.ac.jp

Name of contact person

1st name	Hiroyuki
Middle name
Last name	Murota

Organization

nagasaki university

Division name

dermatology

Zip code

8528501

Address

1-7-1, Sakamoto, Nagasaki city

TEL

0958197331

Homepage URL

Email

h-murota@nagasaki-u.ac.jp

Institute

Nagasaki university

Institute

Department

Personal name

Organization

self-finance

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Clinical research cencer, Nagasaki univrtsity

Address

1-7-1, Sakamoto, Nagasaki

Tel

0958197331

Email

h-murota@nagasaki-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

12

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2020

Year

03

Month

01

Day

Date of IRB

2020

Year

12

Month

24

Day

Anticipated trial start date

2020

Year

12

Month

24

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The following information obtained as necessary in general practice before and after the time the specimen is collected is used
Patient background: age, sex, occupation, medical history, family history, current medical history, morbidity, and complications.
Test results
a) Imaging studies (only if performed): radiographs, CT images, MRI images, echo findings, PET images
b) Blood tests: blood cell count, white blood cell fraction, CRP, blood sedimentation rate, HTLV-1 antibody, hepatitis B, hepatitis C, AST, ALT, g-GTP, LDH, Cr, BUN, IgG, IgA, IgM, antinuclear antibody, CEA, SS-A antibody, SS-B antibody, anti-DNA antibody, Scl-70 antibody, ARS antibody, MDA5 antibody, TIF1g antibody, BP180 antibody, anti-Dsg antibody, IgE, TARC, view39, MAST36, C3, C4, C1-INH, Na, Cl, K, Ca, P, ASO
c) Physiological examination: sweat test, quantitative scraping analysis results

Preparation of specimens
(Cultured cells) Some tissue and blood cells are cultured in vitro and used for the following studies.
(Preparation of liquid samples) For blood, serum and plasma components are separated and used. (Preparation of liquid samples) For blood, serum and plasma components are separated and used. Sweat is collected and passed through a 0.22um filter for study.
(Pathological specimen of tissue) Paraffin-embedded tissue, cryopreserved tissue, and fresh tissue are used.
(Protein samples) Liquid samples should be diluted and used for research. (Protein samples) Liquid samples should be diluted and used for research. Tissue and cell samples should be extracted using a homogenizer and lysis solution.
(Nucleic acid samples) RNA should be extracted using a kit and following the protocol provided by the provider.
(Cotton swab scraped from skin surface) Used for bacterial flora examination.

Registered date

2020

Year

12

Month

24

Day

Last modified on

2020

Year

12

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048896