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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024156
Receipt No. R000027786
Scientific Title Assessment of the prognosis of the patients of connective tissue disease.
Date of disclosure of the study information 2016/09/26
Last modified on 2020/03/30

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Basic information
Public title Assessment of the prognosis of the patients of connective tissue disease.
Acronym Assessment of the prognosis of the patients of connective tissue disease.
Scientific Title Assessment of the prognosis of the patients of connective tissue disease.
Scientific Title:Acronym Assessment of the prognosis of the patients of connective tissue disease.
Region
Japan

Condition
Condition rheumatoid arthritis, scleroderma, polymyositis-dermatomyositis, systemic lupus erythematosus, mixed connective tissue disease, Sjogren syndrome, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, microscopic polyangiitis, IgG4-related disease.
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Reveal prognostic factor of collagen disease and complications risk factors.
Basic objectives2 Others
Basic objectives -Others Overall survival
progression-free survival
complications
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Overall survival
Key secondary outcomes progression-free survival
complications

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
16 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who meet the following of one of the diagnostic criteria.
1) 2010 ACR/EULAR classification criteria for rheumatoid arthritis.
2) 2013 classification criteria for systemic sclerosis
3) Bohan and Peter criteria for polymyositis and dermatomyositis
4) 2012 SLICC classification criteria for systemic lupus erythematosus
5) 2004 Preliminary diagnostic criteria for mixed connective tissue disease proposed by Ministry of Health, Labour and Welfare in Japan.
6) 2012 ACR classification criteria for Sjogren's syndrome
7) 1990 ACR classification of Churg-Strauss syndrome (allergic granulomatosis and angiitis)
8) 1990 ACR classification of Wegener's granulomatosis (granulomatosis and angiitis)
9) 1999 diagnostic criteria for microscopic polyangiitis by Ministry of Health and Welfare in Japan.
10) 2011 Comprehensive diagnostic criteria for IgG4-related disease by Ministry of Health, Labour and Welfare in Japan.
Key exclusion criteria 1) Patients who are judged to be inappropriate as a research subject by the principal investigator or research team members.
2) Patients who are considered to be difficult to obtain a valid consent.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Kubo
Middle name
Last name Makoto
Organization Yamaguchi University Hospital
Division name Internal Medicine 2
Zip code 755-8505
Address 1-1-1,MinamiKogushi,Ube City,Yamaguchi Prefecture,Japan
TEL 0836-22-2248
Email mkubo@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Kubo
Organization Yamaguchi University Hospital
Division name Internal Medicine 2
Zip code 755-8505
Address 1-1-1,MinamiKogushi,Ube City,Yamaguchi Prefecture,Japan
TEL 0836-22-2248
Homepage URL
Email mkubo@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Hospital
Institute
Department

Funding Source
Organization None
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 Center For Clinical Research, Yamaguchi University Hospital
Address 1-1-1,MinamiKogushi,Ube City,Yamaguchi Prefecture,Japan
Tel 0836-22-2428
Email me223@yamaguchi-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 山口大学医学部付属病院(山口県) Yamaguchi University Hospital

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 26 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
2016 Year 07 Month 27 Day
Date of IRB
2016 Year 07 Month 27 Day
Anticipated trial start date
2016 Year 09 Month 26 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 03 Month 31 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information This study is a prospective observational study that does not involve the intervention.
The subjects of the present study are collagen vascular disease patients who meet the selection criteria and are admitted to Yamaguchi University Hospital until December 2019 from September 2016.
Patients are followed for five years and are evaluated a multi-factor analysis including its prognostic factor and risk factor of complications. Analysis items are such as a blood test findings, urinary findings, imaging findings, physiological laboratory findings and biopsy findings. Survival of the subject patients, exacerbation of collagen disease, complications are evaluated after five years of registration.

Management information
Registered date
2016 Year 09 Month 25 Day
Last modified on
2020 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027786

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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