UMIN-CTR Clinical Trial

Basic information
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
Condition	Skin-related diseases
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Establishing new treatment by elucidating the pathogenesis of skin diseases
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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 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

Research contact person
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

Public contact
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

Sponsor
Institute	Nagasaki university
Institute
Department

Funding Source
Organization	self-finance
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	Clinical research cencer, Nagasaki univrtsity
Address	1-7-1, Sakamoto, Nagasaki
Tel	0958197331
Email	h-murota@nagasaki-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 12 Month 24 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	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

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.

Management information
Registered date	2020 Year 12 Month 24 Day
Last modified on	2020 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048896